Clinical Data Manager Resume Samples

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L Weimann

Lysanne

Weimann

1177 Marion Rapid

Phoenix

+1 (555) 238 9943

1177 Marion Rapid

Phoenix

Phone

p +1 (555) 238 9943

Experience Experience

New York, NY

Clinical Data Manager

New York, NY

Medhurst LLC

New York, NY

Clinical Data Manager

Provide input into the development of data management SOPs and processes. Write or review Data Management work instructions and SOPs
Work with the Manager of CDM to create, modify and implement data management processes
Assists in the development of data management plan for study design and database content development
Develop and execute database queries and perform discrepancy management
Assist in developing data management process and procedure improvements
Assist with developing test cases and performing user acceptance testing of EDC systems
Provides expertise in the data management area to study managers, statisticians, and statistical/clinical programmers

San Francisco, CA

Lead Clinical Data Manager

San Francisco, CA

Hermiston and Sons

San Francisco, CA

Lead Clinical Data Manager

30% Delivering Excellence: Takes leadership role in project implementation
Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire’s quality standards and SOPs
Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment
15% Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve

present

Philadelphia, PA

Senior Clinical Data Manager

Philadelphia, PA

VonRueden, Rodriguez and Crona

present

Philadelphia, PA

Senior Clinical Data Manager

present

Manages data management personnel including hiring, performance management, training, and resource allocations
Direct team members in daily activities including training and supervising Clinical Data Managers I and II
Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance
Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling
Lead Case Report Form Design according to the protocol with all Study Team members using established standards
Responsible for ensuring the integrity of data and providing recommendations for corrective action when necessary
Liaise with Biostatisticians regarding data validation and lock of the database, including management of discrepancies

Education Education

Bachelor’s Degree in Life Science

Northeastern University

Bachelor’s Degree in Life Science

Skills Skills

Ability to attain, maintain and apply a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Knowledge or ability to rapidly gain knowledge with programming/query languages
Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs
Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
Ability to prioritize activities and consistently meets deadlines according to accepted levels of quality, paying attention to details
Ability to prioritize and to adapt quickly to changing business conditions plus a “can-do” attitude
Logical thinking, attention to detail, good organizational skills, and problem-solving abilities
Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices)
Good communication skills with the ability to communicate with both the technical and business areas
Excellent problem solving skills and ability to think creatively

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Clinical Data Manager Resume Examples & Samples

Associate's Degree in related Clinical Science studies
AHIMA certified with the following current credentials: CCS,, RHIA or RHIT
ICD 10 certification
Master's Degree in related field

Lead Clinical Data Manager Resume Examples & Samples

30% Delivering Excellence: Takes leadership role in project implementation
As a member of the clinical study or project team, ensures oversight of the Data Management CRO ; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO
Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of SAS data deliverables according to internal and regulatory standards
25% Accountability and Ownership: Drives accountability at every possible level
Collaborates with CRO and study team members to identify and resolve issues impacting goal attainment
15% Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
Provides within and between study comparisons of DM timelines for assigned projects. Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve
Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results
10% Courage to challenge: Takes risks and challenges norms to support tomorrow’s needs
Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations
10% Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
Supports each clinical study and project team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams’ long-term needs are addressed
As Data Management lead to the clinical study, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view
10% Building Authentic Relationships: Building trusting relationships that will enhance current and future needs
Leads in developing trust through transparency in communication and individual actions; ensures outcomes are team driven rather than individually driven; promotes collaborative team and organizational success
Minimum of 5-7 years as a Sr. Data Manager within a Data Management organization
CCDM certification preferred
Must be able to produce data management reports
Strong attention to detail and accuracy is a must
Ability to read, analyze and interpret complex technical documents
Ability to present complex issues in oral and written form
Strong knowledge of MS Word, Excel, PowerPoint, Access and Outlook
Must be able to independently present complex information to departmental management, professional organizations, CROs and the medical community
Proven ability to manage and communicate effectively with research vendors including reviewing request for proposals, analyzing scope of work, budgeting and forecasting, responding to inquiries and complaints
Demonstrated ability to prioritize across work assignments
Proven ability to independently resolve problems
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
Understanding and facility with CDISC/CDASH standards
Demonstrated knowledge of data management and drug development process
May be responsible for supervising Clinical Data Management contractors

Clinical Data Manager Resume Examples & Samples

Bachelor’s degree in Mathematics, Science or related discipline
3+ years of clinical data management experience in the biotechnology or pharmaceutical industry
Oncology and/or ophthalmology experience preferred
Familiarity with all applicable regulations including; CFR, GCP, and ICH Guidelines
Software proficiency with CDMS required

Senior Clinical Data Manager Resume Examples & Samples

Bachelor’s degree in scientific or health-related discipline
5+ years of experience in data management, preferably within a pharmaceutical company
Solid SAS or other relevant programming skills, with experience in relational databases
Knowledge of CDM systems, Clinical Operations SOPS and Working Practices
Familiarity with ISO 9001:2000 requirements

Clinical Data Manager Resume Examples & Samples

BS or BA in relevant field
2+ years of clinical data management experience, including database set-up, data validation and consistency checks, initiation and closure of trial databases, CRF design, query resolution, review and reporting of laboratory and safety data, coding, and SAE reconciliation or equivalent
Proficient in the use of clinical data management systems, including paper based and EDC systems, IVRS systems, and online enrollment
Knowledge of applicable regulatory rules and guidelines
Knowledge in the use of data management tools
Knowledge of clinical data acquisition standards harmonization (CDASH), experience with SAS programming or relational databases

Senior Clinical Data Manager Resume Examples & Samples

50% Delivering Excellence: Provides functional expertise in project implementation
Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization
Works with team members via matrix relationships (internally or at CROs) by directing work, resolving problems and/or providing guidance
Supports each clinical study team by ensuring data management plans and data handling activities are designed to meet project and protocol deadlines. Consults with the team(s) to ensure the teams’ long-term needs are addressed
Leads development of Data Review Plans; contributes to other key study level documents (e.g. protocols, SAPs)
30% Accountability and Ownership: Drives accountability at every possible level
Ensures Data Management CROs are delivering quality data and documentation on time, on budget and to Shire’s quality standards and SOPs
Reviews Data Management CRO performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
Ensure consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations
20% Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
Contributes regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results
Minimum of 5 years as a Data Manager within a Data Management or service organization

Lead Clinical Data Manager Resume Examples & Samples

5-7 years as a Senior Data Manager within a Data Management organization
Bachelor's Degree in the sciences
Strong knowledge of end-to-end clinical research and data management processes, as well as global regulatory and industry rules and guidelines
CCDM certification

Lead Clinical Data Manager Resume Examples & Samples

3-7 years of experience as a Lead Data Manager
Experience working with or managing a CRO
Able to independently present complex information to departmental management, professional organizations, CROs and the medical community
Ability to produce data management reports
Excellent communication skills $
Pharmaceutical/biotechnology industry experience
CCDM Certification

Clinical Data Manager Resume Examples & Samples

4+ years of experience in Drug Development; 3+ years of experience in Clinical Data Management
University or College Degree in a related field
Degree in Life Sciences, Computer Science, Pharmacy, and Nursing

Lead Clinical Data Manager Resume Examples & Samples

30%: Delivering Excellence: Takes leadership role in project implementation
25%: Accountability and Ownership: Drives accountability at every possible level
15%: Judgment and Decision Making: Evaluates immediate business impact and takes decisive action
10%: Courage to challenge: Takes risks and challenges norms to support tomorrow’s needs
10%: Serving Customers: Partnering with customers as a trusted consultant and becoming an integral part of customer’s decision making
10%: Building Authentic Relationships: Building trusting relationships that will enhance current and future needs

Lead Clinical Data Manager Resume Examples & Samples

As Data Management lead to the clinical study and project teams, becomes involved in decision making processes to ensure maximum performance of the team. Provides Data Management expertise to the teams in customer oriented point of view
Mentors team members, junior staff or contractors via matrix relationships (internally or at CROs) or direct supervision, by directing work, resolving problems and/or providing guidance
Communicates closely with Data Management CRO contacts outside of the project and study team in order to ensure that the CRO is acting as an extended workforce
Assists in the development of proposal requests and/or budget grids, reviews budget proposals and may support selection of data management service providers
Contributes to regular budget forecasting and cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results
Supports consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to DM Operations. Evaluates need for updates and modifications to improve individual project and overall organization-wide efficiency
Minimum 8-10 years as a Sr. Data Manager and/or Manager within a Data Management organization
CCDM certification strongly preferred

Clinical Data Manager Resume Examples & Samples

Assists in the development of data management plan for study design and database content development
Assist in configuration of the data content collection in the EDC system per the research protocol
Assist in eCRF testing, edit check development and configuration, documentation, and user training prior to going live
Per project needs, help program specific reports in the EDC system or using SAS, writes reports specification as required by the project's needs
Assists in the dissemination of results/findings and maintains communication patterns with physicians, hospital staff and study sponsors
Acts as liaison with all study team members and other functional groups on all levels on technical requirements for database development and data quality within a study
Assists with new proposals and business development activities

Senior Clinical Data Manager Resume Examples & Samples

10 years data management experience, or B.S. /B.A. in a science or technical discipline degree with 6 years data management experience, or MS degree with 4 years data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment
Meet the requirements of a Clinical Data Manager II with a high degree of proficiency and autonomy
3 years' experience supervising Clinical Data Managers and team activities
Ability to program in SQL or SAS desirable, but not required
Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes
Ability to work in a collaborative and multi-disciplinary environment

Clinical Data Manager Resume Examples & Samples

Strong Microsoft Office skills required
Working knowledge of industry standards such as CDISC, SDTM, CDASH
Knowledge of CDISC SDTM data structures and basic SAS programming skills preferred
Excellent communication skills and technical writing experience
Perform all data management activities from study start-up to database lock
Create study related documents (data management plan ,CRF completion guidelines, laboratory specifications, edit check specifications)
Perform data review and query resolution
Design Case Report Forms
Perform medical dictionary coding using WHODD and MedDRA
Review external data file imports and reconciliation

Clinical Data Manager Resume Examples & Samples

Data Gathering
Participates in the reliable collection of preoperative, operative, and postoperative components for approximately 2,000 heart cases per annum
Participates in the collection of reliable, valid data for comparative risk-adjusted outcomes of Cardiac Surgery
Demonstrates appropriate utilization of resources necessary to obtain valid, reliable clinical data
Demonstrates applicability of methodology and reliability of data definitions and reviews through inter-reliability testing
Identifies areas for streamlining and improving the data collection process. Provides ideas, recommendations and alternative strategies where appropriate
Elicits support necessary to obtain valid, reliable data for reporting to regulatory agencies
Maintains up to date knowledge of regulatory changes of definitions and variables for reporting data
Ensures and maintains confidentiality of data in compliance with HIPAA and PHS Human Research Committee regulations
Software Management
Responsible for determining and utilizing software applications available at BWH for data collection and analysis
Participates in the accurate entry of data into the program’s software to ensure the transmission of completed data to regulatory agencies as required (STS, DPH)
Assists in the testing of the functionalities of the web application as an Alpha test site and provides feedback and comments for the purpose of identifying ways of enhance the data entry to improve performance
Works Effectively with Patients, Families, and Staff
Collaborates in a professional manner with all members of the healthcare team to promote the goals and objectives of the Division of Cardiac Surgery. This will require working with a wide variety of individuals, Divisions and Organizations
Collaborates in a professional manner with colleagues involved in data collection and reporting at local, regional and other cardiac surgery site(s)
Maintains a professional relationship with patients and families via telephone and written communications for 30 day post operative follow-up data collection
Educates lay and professional individuals and groups as to the nature of the project through individual as well as public presentations as needed
Clinical Research Application
Participates in the preparation and presentation of clear, precise and clinically accurate summaries of findings including their significance and implications to various audiences
Participates in the preparation of appropriate clinical criteria and/or benchmarks for medical review
Utilizing the analysis of the study data and professional expertise, provide recommendations to improve patient care
Possesses clinical knowledge of medical care processes and the analytical ability to correlate clinical diagnosis and symptoms with established diagnostic and treatment modalities
Bachelors degree in related health care field required, Master’s preferred
Minimum 3-5 years of clinical experience, preferably in surgical critical care and/or cardiothoracic surgery
Working knowledge of cardiac procedures and terminology
Computer proficiency required – familiarity and comfort with MS Office products is essential for success in this position (Word, Excel, PowerPoint and Microsoft Access)
Medical record review and abstraction experience preferred
Database management experience strongly preferred
Meticulous attention to detail and problem solving skills
Statistical knowledge highly preferred
Background in quality improvement/assessment or utilization management strongly preferred

Clinical Data Manager Resume Examples & Samples

Develop eCRF design requirements; review and approve eCRF specifications according to protocol and approved standards
Ensure proper documentation/availability (e.g., Data Management Plans)
Liaise with and oversees external vendors (e.g., EDC, CROs, laboratories)
Provide training for team members in data management procedures
Ensure proper clinical data review and query management
Ensure SAE and external data reconciliation
Experience with EDC (e.g., Medidata Rave, Oracle Inform)
Familiarity with CDISC/CDASH and standard international coding dictionaries (e.g., WHODD, MedDRA)
Provide oversight of data management activities to ensure progress according to study timelines
Ensure proper collection and validation of data and documentation on a timely manner
Organize study specific meetings (e.g., Patient Validation, Medical Review)
Participate in the development/follow-up of the study budget and selection and management of vendors
Mentors/trains new comers

Lead Clinical Data Manager Resume Examples & Samples

Serve as Lead Data Manager for multiple projects/trials from multiple franchises and providing professional Data Management input to Clinical Trial Teams (CTTs)
Responsible for ensuring consistency of protocols, project CRFs, clinical databases for all trials within assigned projects and provide technical feedback to CPOs as needed
Provide CDM input to study protocols and Study Specification Worksheets (SSW) for CPO proposal requests; provide input/create quotes
Develop CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings, and Validation and Analysis Plans (VAPs) as appropriate
Ensure complete and consistent medical term coding using appropriate standard dictionaries; ensure consistency of serious adverse event data across clinical and drug safety databases
Monitor clinical data quality and progress of trials with CTS; drive corrective actions as needed; ensure proper integration of third-party/non-CRF data as applicable
Proactively identify project threats and resolve issues with clinical trial teams; escalate to CTS management if necessary and appropriate
Ensure up-to-date and accurate tracking of report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues
Provide input, review, and maintenance of local working practices and standards
Participate in the development of a Data Management organization through his/her leadership role within the DM Group for CTS
Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, and mentoring of other Data Management staff
University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree
Ideally 4 or more years experience in drug development, with at least 3 years in Data Management activities
Experience in managing outsourced studies or working for a CRO
Understanding SAS output and introductory level skills with SAS
Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding
Project team leadership experience; good organizational and project management skills
Good technical and problem solving skills
Good interpersonal and communication skills and ability to operate effectively in an international environment
Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners

Expert Clinical Data Manager Resume Examples & Samples

Skilled on a range of systems/tools in use by Novartis and by Contract Research Organi-zation (CRO) partners and how to work with each accordingly
Effectively refines requirements for data validation based on metrics generated and les-sons learned from cleaning activities
Responsible for ongoing review of data, database maintenance & creation / maintenance of study documentation
Ensures the review of listings for quality, content, format and output
Supports & assists junior staff for assigned trials (e.g. raising data issues for Data Review Team (DRT) attention)
Responsible for the final review of data and finalization of the study documentation
Responsible for the final review of listings for quality, content, format and output
Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure timely deliverables (incl. Snapshots and interim/final locks)
Ensures creation of study specific project plans
Prepares feedback information about sites query performance and data entry compliance
Plans appropriately to ensure adherence to timelines, including assignment of workloads and identifying resource and timeline issues within and across programs
Interacts at International Clinical Teams (ICTs) and Biometrics and Data Management (BDM) Project Teams
Ensures adherence to GCP, DM standards, SOPs/Working Practices (WPs) and process guidelines
Able to effectively represent DM in SOP reviews and updates
Participates in Health Authority Inspections and assists in responding to requests for information from Health Authorities on DM related topics
Responsible for managing all study documents required during a Regulatory or internal audit
Acts as cross-functional subject matter expert and presents at or chairs forums in areas of expertise
Mentors and trains new colleagues and/or other team members as assigned
Provides ongoing training and development of direct reports (if applicable)
Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
Proposes solutions to address resource and timeline issues
Provides ongoing input on performance of team members to next level manager

Clinical Data Manager Resume Examples & Samples

Prepare training materials for data management activities and processes as required
Travel is required as needed
University Science Degree in life sciences, phar-macy, nursing or equivalent relevant experience
Excellent written and oral English skills
Understanding of clinical trial methodology, GCP and medical terminology
Good organizational and project management skills. 7.Good communication and interpersonal skills 8.Intermediate presentation and problem solving skills 9.Ability to work well in a team 10.May coordinate and provide direction on task to other data management team members

Senior Clinical Data Manager Resume Examples & Samples

Identify and make recommendations on trends in data discrepancies and remediation, e.g., developing instruments to effectively identify trends in data discrepancies, identifying need for training and recommending appropriate training programs
Lead project management activities for multiple complex (multi-site and multi-cohort) projects to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders
Develop Data Management deliverables including data management plans (DMPs), training materials and user aids
Review and clean data according to DMP (Data Management Plan), SOPs and associated documents using the clinical data management system, listings, and reports
Perform Site/User Administration, developing Electronic Data Capture (EDC) applications for user completion to allow access to the database, ensuring all users are qualified to access data base
Participate in development and review of SOPs, work instructions, and associated documents for CDM, including recommending revisions and updates to SOPs, participating in the development of user training
Bachelor’s degree required, preferably in life sciences
Ability to understand protocols, DMPs, SAPs, and to collaborate effectively with the Clinical study teams

Clinical Data Manager Resume Examples & Samples

Bachelor’s degree in life sciences, math, computer science or related field required
Master’s degree in life sciences, math, computer science or related field preferred
Minimum of five years clinical data management experience
Prior experience with biostatistics and SAS programming preferred
Thorough and broad knowledge of data management processes, including EDC and IVRS experience
Knowledge of regulatory guidelines such as GCP, 21 CFR Part 11 etc
Knowledge of study data tabulation model (SDTM)
Must have excellent verbal, written and communication skills
Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast paced environment
Demonstrated ability to stay abreast of trends and new information in the profession
Demonstrated leadership and project management skills
This position will travel occasionally; the average travel for this position is 15-20% with some variation based upon the demands of the business imperatives

Senior Clinical Data Manager Resume Examples & Samples

Serve as the primary contact for contract research organization (CRO) and vendor interactions, including development of the RFP, defining deliverables, ensuring data quality, problem resolution, and monitoring project activity
Supports study teams by providing standards for data capture and safety data, assessing the overall quality of data and identifying and escalating key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns, e.g., frequency of queries and protocol deviations
Responsible for standardization of DM processes and process improvement and efficiency
Responsible for the implementation of DM systems (i.e., electronic data capture [EDC]) for clinical trials including database build, CRF development, user acceptance testing (UAT), edit check specification development
Develops or oversees development of DMPs to define the data collection and processing workflow for clinical studies
Performs database lock activities to ensure the accuracy and completeness of final clinical trial databases prior to submission to Biostatistics for analyses and submission to the FDA and other regulatory agencies in other countries
Participates in vendor and technology (e.g., EDC) evaluation, qualification and selection. Supports RFP development, budget and contract negotiation, as needed
Works in conjunction with the clinical development team on case report form design, data collection processes, query generation procedures, and project timelines
Develop guidelines and material to support clinical operations in the area of data listing reviews, data analysis, and data presentation
Oversees related activities outsourced to DM service providers as well as other external data sources (e.g. central and/or specialty labs, IVR vendors, etc.) from study start-up through study close-out and final database lock/transfer/integration
Manages adjudicated safety events and reconciliations between clinical and safety databases
Act as a liaison with all study members and other functional groups on all levels on technical requirements for database development and data quality within a study
Accountable for completing project deliverables on schedule, on budget, and according to quality standards and requirements from study start-up through archival
Responsible for ensuring SOP and regulatory compliance with FDA regulations, GCP, ICH guidelines and Good Clinical DM Practices internally and with DM vendors via regular process auditing. Ensures DM project documentation is in an inspection-ready state
Oversees the development of data validation specifications and programs for assuring the accuracy of clinical trial data, e.g., data review guidelines, computerized edit check programs, DMPs
Provides input and participates in development of clinical study documents including protocol and monitoring plans, and CRF completion instructions
Able to cultivate effective and productive working relationships with colleagues, vendors and management. Able to use clear judgment to solve problems and to escalate issues with proposed solutions, as necessary
Develops SOPs and specific quality processes and procedures for Data Management
Perform additional duties as needed in support of clinical study teams or department activities

Clinical Data Manager Resume Examples & Samples

Contribute to the decision-making process involving data management issues for Phase 1-Phase 3 studies
Work on/lead cross-functional teams and lead outsourced vendors to produce high quality data
Provide oversight and participate in study setup and initiation procedures such as case report form design, database design, edit check design/review, Data Management Plan review/approval and annotated case report form design
Ensure clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and a possible regulatory submission by working with lead CRO data manager or equivalent
Coordinate and participate in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
Ensure clinical data within EDC is of a quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock
Maintain the study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial
Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis including raw datasets and bookmarking annotated CRFs
Develop data management guidelines and quality processes to ensure final operational data and databases are accurate, complete and consistent
Work closely with study functional leads and project managers to develop timelines and review budgets and contracts to ensure departmental and corporate clinical trial data management objectives are met
Develop/utilize study metrics to monitor quality, project status, activities and budget and work with Manager to identify trends and provide updates/recommendations on opportunities for improvements
Participate in department and process improvement initiatives
BA/BS and 3+ years of experience in a data management role in a CRO or pharmaceutical/biologics/biotechnology company
AS and 6+ years of experience in a data management role
High School Diploma and 10+ years of data management experience
Experience as lead CDM managing studies from start-up through close-out (including data management activities related to study conduct, study completion and archiving of study materials)
Experience must include management of outsourced CDM activities
Experience with an electronic data capture data management system (e.g., Rave or Oracle RDC)
Familiarity with coding of medications, medical conditions, and AEs/SAEs using MedDRA and WHODRUG dictionaries
Proficiency in basic SAS and/or JMP or a demonstrated ability to learn basic programming skills
Understanding of ICH GCP as well as general knowledge of industry practices and standards (CDISC, SDTM, CDASH)
Ability to prioritize and effectively manage several projects simultaneously
Aptitude for attention to detail

Clinical Data Manager Resume Examples & Samples

Familiarity with industry standards or proprietary data management systems/software for managing and reporting clinical trials data
Familiarity with Windows environment, Office 2010 (including MS Access), Visual Basic, SAS, SQL and/or other clinical programming
Demonstrated ability to work on multiple projects simultaneously. Demonstrated experience with Electronic Data Capture (EDC)

Clinical Data Manager Resume Examples & Samples

Responsible and accountable for managing all Data Management deliverables from study start up to study close
Perform protocol review
Responsible to manage CRO vendor and perform oversight of study if applicable
Ensures adherence to GCP, DM standards, SOPs and process guidelines
Create and maintain study documentation in accordance with SOPs (e.g. DMP, CRF design, CCG’s, UAT, DVS, SAE reconciliation, and coding guidelines) and assures consistency and adherence across trials
Perform day to day related DM functions including data review, generating queries, review of data listings, coding, SAE reconciliation and ensure high quality data available for analysis and reporting
Identifies trends in the data and possible solutions for efficiencies
Provide input for DM initiatives, innovation and quality
Assist in development or updating of SOP
Cross-functional team player who is able to build effective work relations throughout the organization to achieve business goals
BA degree or equivalent experience in a health care or related field
3-5 years of clinical data management experience as well as 1+ years as a lead data manager
Thorough understanding of clinical data management and therapeutic area of Oncology preferred
Experience working with EDC platforms

Principal Clinical Data Manager Resume Examples & Samples

Serve as lead CDM on assigned clinical trials. Attend clinical trial project team meetings as lead CDM. Manage clinical trial and project database lock activities. Manage and monitor external vendors and clinical projects from start-up to completion according to project deadlines
Manage the definition and user acceptance testing of programmed edit specifications and data review reports on assigned clinical trials
Perform pre-, during, and post-data entry review of clinical data, identify data discrepancies and corresponding resolutions, and generate and manage queries on assigned clinical trials
Develop, document, maintain and finalize the data management manual (DMM)
Develop, implement and maintain the global standard CDASH case report form library, code lists, and process documentation. Implement and maintain the CDASH eCRF standards in Medidata/RAVE
Provide ongoing technical support of Medidata/RAVE during clinical trial conduct including development of clinical trials in EDC according to CDASH, provide ad-hoc report development, and support database lock and archiving activities
Review and contribute as a member of the CRF development team to develop the data collection modules on assigned studies
Manage centralized dictionary coding of clinical data to MedDRA and the World Health Organization Drug Dictionary. Generate and manage associated queries to identify and correct data issues to ensure accurate coding. Manage the creation and updating of standard dictionary coding guidelines and coding reports
Develop standard operating procedures (SOPs) with CDM management
Train peers on clinical data management activities and procedures
Provide guidance to clinical data management personnel on assigned projects
Set-up, maintain and archive electronic and hard-copy project documentation
Independently monitor own activities and project status for successful project deliverables according to timelines
Perform other additional tasks as requested by CDM management and personnel
Demonstrate strong medical terminology skills
Experience defining, entering, processing, reviewing and validating clinical data; and understanding and following clinical trial protocols and data collection documents
Proficient implementing and operating the EDC product Medidata/RAVE. Experience with Oracle Clinical/Inform a plus
Proficient with: (a) CDASH, (b) dictionary coding with MedDRA and the World Health Organization Drug Dictionary (WHO-DD), (c) SAS for data review
Possess effective written and verbal communication skills, interact professionally with personnel at all levels within and external to the company, and be dependable and a team player
Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be capable of working under deadlines
Capable of working on multiple projects simultaneously, independently manage responsibilities according to deadlines, and define tracking tools to manage projects
Experience in solving extremely complex and increasingly difficult problems, taking appropriate corrective action, and identify and implement improvements
Possess a thorough knowledge of Data Management SOPs and regulatory requirements, and be capable of providing guidance to and training peers

Clinical Data Manager Resume Examples & Samples

2+ years’ experience in comparable position within the pharmaceutical, biotech or CRO industry required
Familiarity with SAS desirable
Experience working with office productivity tools including Word, Excel and Access preferred
Understanding of clinical trial terminology desirable

Clinical Data Manager Resume Examples & Samples

Adhering to all Bioclinica Clinical Data Management (CDM) procedures, policies, and work instructions
Working with CDM management to discuss and seek resolution to department issues
Reading, understanding and adhering to applicable Standard Operating Procedures (SOPs)
Participating in the review and updating of company SOPs related to DM Services

Clinical Data Manager Resume Examples & Samples

Education: Bachelor’s degree preferred
CCDM Certified Professional a plus
6+ years of data management or relevant clinical research experience required
Experience working with computer software including Word, Excel and Access preferred
6+ year of experience working with clinical trials and/or within pharmaceutical environment preferred
Broad knowledge of drug development process
Thorough knowledge of effective clinical data management practices
Understanding of clinical development budgets and relationship to productivity targets
Understanding of time and cost estimate development and pricing strategies
1+ years supervisory experience, managing the other of others

Clinical Data Manager Resume Examples & Samples

Assist USAMMDA Chief of Data Management in implementing infrastructure for the discipline of clinical data management for FDA regulated clinical studies in human subjects
Write, read, implement and assist in training on clinical data management SOP’s, templates and forms, (i.e. including but not limited to: data management plan SOP and template, data audit plan SOP and template, and edit specification plan and template)
Review and provide documented comment on protocols prepared for FDA regulated clinical studies in human subjects by principal investigators and/or partners as requested under guidance and shall prepare data management sections of regulatory and clinical documents
Create and/or review Case Report Forms and database specifications, as well as reviewing GCP quality control requirements. This skill also requires mentoring, reviewing and advising trial teams
Address evolving customer needs for clinical design services, performance requirements, and procedural or application solutions
Identify, assist to implement and execute new clinical data management procedures with the lead Clinical Data Manager to plan resources and timelines for projects
Perform all other clinical data management activities, to include, but limited to data review, medical coding, data transfer management, Serious Adverse Event (SAE) reconciliation, database lock/unlock, data archive, assist with budgeting
Possess experience in a clinical trial environment and/or performing clinical data management activities. Possess knowledge of FDA regulations and ICH standards for design, conduct, and analysis of clinical trials
Possess a bachelor’s or master’s degree in a science or computer discipline required and experience of 6 or more years in a clinical trial environment and/or performing clinical data management
This task is IT/ADP II and requires Secret access; therefore this individual shall have a completed National Agency Check with Law and Credit adjudicated by Defense industrial Security Clearance Office (DISCO) for a Secret clearance prior to the commencement of work on this contract
Position requires the ability to obtain secret level clearance

Clinical Data Manager Resume Examples & Samples

Thorough understanding of Good Clinical Practice (GCP), Good Clinical Data Management Practices (GCDMP), and Clinical Data Management (CDM) tasks with ability to critically evaluate the information in relation to key project documents and processes
Performs data management activities / tasks related to project(s), as needed
Provides leadership and trains Data Management staff assigned to work on their projects, including Clinical Data Coordinators and supports training of project staff
Monitor activities / tasks vs. contractual obligations for CDM and report any out of scope items to the Management Team within Clinical Data Management and, as necessary, Project Management
Monitors the quality and coordinates all data management QC activities for the project, participating in audits as needed
Work with Project Management and Sponsor on start−up activities. Approving documentation as required by SOPs
Writes, updates/reviews and approves all required trial data management documentation. Including but not limited to

Clinical Data Manager Resume Examples & Samples

Manage clinical study data collection, including monitor of case report form receipt and process pertaining to data entry
Manage and partner with external CDM vendors such as CROs, EDC, central and local labs to ensure CDM related activities including clinical study data collection from study start-up to study close-out and final database lock/transfer while ensuring that all study deliverables and milestones are met on time and within budget
Examine complex CDM technical issues from various perspectives by utilizing appropriate CDM concepts and resources
Develop and execute database queries and perform discrepancy management
Timely review and resolution of discrepancies through communication with site coordinators and team members
Assist and/or manage study budgets and vendor budgets and invoices
Provide CDM operational direction, planning, execution, collection and handling of all clinical data to the highest quality standards
Provide direction and training to further develop staff as needed

Clinical Data Manager Resume Examples & Samples

Assist with designing CRFs and eCRFs for data acquisition and data entry
1-3 years of related professional experience
Ability to use a combination of Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require

Senior Clinical Data Manager Resume Examples & Samples

Provide clinical data management support to Clinical Operation teams and to clinical projects
Review and update clinical study documents (e.g. protocols)
Set up the clinical database including consistency checks defined in the Data Validation Plan
Develop Data Transfer Agreement with external data vendors and/or core labs
Conduct data quality review meetings during the study execution
Liaise with Biostatisticians regarding data validation and lock of the database, including management of discrepancies
Prepare and maintain key documents for the Data Management of Clinical Trials file
Collaborate with cross-functional internal resources (clinical data manager, clinical project manager, scientists, medical directors) on different health benefit areas
MSc degree with a scientific background
Minimum of 4 years’ experience in the field of clinical research
Knowledge of industry standards and best practices in data management and regulatory guidance (ICH, CDISC)
Experience with Data Management Systems such as Medidata
Good communication and team-player mindset
Central monitoring and analytical skills are a plus

Principal Clinical Data Manager Resume Examples & Samples

Excellent written/ verbal communication skills with a strong command of English language and grammar; strong organizational and analytical/problem solving skills; strong customer focus and excellent interpersonal skills
Ability to identify project risks and to effectively evaluate and develop plans to mitigate those risks
Ability to train and direct a study team, providing leadership and direction to both subordinates and peers
Ability to forecast project resourcing, project timeline planning and adherence to timelines
Ability to successfully apply above skills, knowledge and abilities across a portfolio of studies or with a franchise client

Clinical Data Manager Resume Examples & Samples

Bachelor's degree or equivalency in education (e.g., R.N., M.T., P.A., R.Ph, etc.) and experience demonstrating theoretical knowledge of biology, chemistry, physics, and/or health sciences, or closely related
3+ years of data management experience
Or a combination of performance, education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Proven flexibility and adaptability
Ability to act as a study or department expert for DM processes
Ability to assist in forecasting project resourcing and hours needed

Clinical Data Manager Resume Examples & Samples

Ensures database accuracy according to departmental operating procedures
Performs a QC review of the data and makes corrections to the DM database
Develops data validation manual
Defines and tests databases and data validation system
Represents Data Management in all cross functional meetings relating to the study
Reviews data listings for consistency and accuracy of data
Develops and maintains data management project documentation files
Performs independent reviews of data management deliverables following documented guidelines
Acts as an interdepartmental and sponsor liaison for all DM study activities
Produces project-specific status reports for management and sponsors
Monitors study metrics
Analyzes and resolves discrepancies in data validation or other reports
3+ years work experience in a professional environment, preferably within a clinical or medical data environment, including 2 years of data management experience
Knowledge of Oracle Clinical (preferred)
Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
Good organizational and analytical/problem-solving skills

Clinical Data Manager Resume Examples & Samples

Create and/or review study-specific Case Report Forms (CRFs) using prior device knowledge, protocol specific information and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner
Configure, migrate, and test EDC databases based on internal procedures, approved requirements and system best practices. Serve as project database manager for the study specific clinical team, including compilation of edit checks
Develop database requirements for use by EDC vendors. Serve as project database manager and work with vendors to obtain deliverables in a timely manner
Create and/or review study-specific data management and database documentation, which may include: Data Management Plan, CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, and Edit Check Specifications
Attend study-specific team meetings and produce requested metrics, which may include query information or data trends
Provide status reports or expert guidance on how they should be programmed or designed
Perform data review and query generation/closure
Perform coding of verbatim terms. Collaborate with Medical Sciences for coding, consistency, review and approval. Transfer coding file to biostatistics
Identify improvement related to departmental processes. As applicable, participate in development of a new process or revision of an existing process and review drafts
Train internal colleagues in clinical data management in either informal or formal classroom settings as needed
Train Investigators and Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed
Provide data management expertise and support to the clinical teams using data management best practices
Provides analytic insight on data management strategies and advises internal team with tactical strategies accordingly
As necessary, provide work direction, guidance, mentoring, influence and support to junior staff. Train junior staff in more complex clinical data management processes
Demonstrates a passion for learning, sharing and discovering new information. Builds solid relationships of trust across the organization
Considers the vision, direction and goals of the organization when setting business or work priorities. Works to understand and influence the matrixed organization and the dependencies between functions, divisions and regions on decision making
Recognizes the need for unique or modified approaches to achieving results and adding value to the direction of the business. Plans for change and perceives it as opportunistic
Fosters an atmosphere of open communication. Speaks and presents effectively and listens to what others have to say
Displays insight in analyzing complex situations, considers various approaches and perspectives in addressing problems, and makes timely decisions, anticipating their potential impact and using sound judgment
Establishes a model for excellence and achieving objectives. Enthusiastic about the work he/she is producing as well as the overall direction of the business
Identifies, defines and evaluates problems. Uses knowledge, experience and judgment to problem solve appropriately for the role
Understands and interprets technical, scientific, and clinical information and applies that understanding to product approval activities
Activities related to targeting, building and maintaining relationships with customers
Good at managing and figuring out processes necessary to get things done. Understand how to separate and combine tasks into efficient work flow. Resulting in effectively managing priorities and completing deliverables on time
Utilizes data, knowledge and experience to deliver information to enable scientific and business objectives
Bachelor’s Degree and 5+ years of clinical research experience, including a minimum of 2 years clinical data management experience
Database Requirements: 1-2 years of Medidata Rave Architect experience; 2+ years of Microsoft Office experience
Preferred: MedDRA coding experience; CDISC awareness
The ability to identify, use, control and manage interpersonal skills

Senior Clinical Data Manager Resume Examples & Samples

Independently abstract data elements from clinical study protocol; may contribute to the design and development of Case Report Form Standards (CRFs) for global clinical studies; provide appropriate input to CRF completion guidelines and annotated CRFs
Independently define data validation and electronic edit checks for database development
Independently plan, manage and report data management aspects of global clinical studies through oversight of data management staff; work with cross functional teams to ensure alignment
Create and report data management updates to management on a regular basis; report on performance to plan
Serve as data management resource to the clinical study team and data management team; assist in preparation of data for clinical study reports, documents for regulatory submission and help with submissions as directed. Mentors newly hired BCDM staff and advises less experienced Data Managers. Oversees the deliverables of contract staff and vendors in Clinical Data Management
Facilitate data cleaning and manage timeline to database lock; interact with study sites as needed; responsible for database lock
Follow current SOPs. Ensure current procedures are efficient and of high quality; may lead process improvement initiatives as directed
Maintain knowledge of current technology, best practices and regulations in the data management space and share learnings with Global Clinical Development and across the business
Perform leadership function in data management, including effective mentoring skills and the ability to deal effectively with internal and external customers; organize and lead internal and external meetings with associated communications and materials
Ensure study level training for users, including but not limited to, clinical study team members and investigational site staff; provide first tier support for CRF completion
Bachelor's degree in computer science, life sciences or related area; or equivalent combination of education and experience
Experience in medical device industry, clinical setting or research field
Data Management/Project Management skills
Knowledge and application of industry standards and best practices in clinical data management and applicable country regulations (e.g., US FDA, ISO-14155, ICH, CDISC)
Proficient with Data Management Systems such as Oracle Clinical, Medidata, Inform or Datafax
Proficient with electronic data capture
Proficient with SQL, Microsoft Access, Excel, Word, Powerpoint, Outlook, Sharepoint, Visio and Project
Proficient with Clinical Trial Management System

Lead Clinical Data Manager Resume Examples & Samples

Previous experience and proven competence in managing delivery of multiple projects through full DM life-cycle (several studies/programmes)
Demonstrated expert data management skills and thorough knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and/or new technology)
Previous experience of handling customer negotiations
Knowledge of Good Clinical Practices and relevant regulatory guidelines
Excellent communication, interpersonal, customer service, and teamwork skills
Excellent organizational and problem-solving skills
Ability to work independently with available resources, e.g., functional managers, senior DTLs
Bachelor’s Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related field, and a minimum of 5 years direct Data Management experience, including 3 or more years as a CDM project lead; or equivalent combination of education, training and experience

Assistant Clinical Data Manager Resume Examples & Samples

Serve as Data Team Lead (DTL) on multiple global studies
Provide leadership to DM team
Manage DM customer relationship for DM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance)
Provide marketing capabilities presentations and business development presentations
Or serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 20 operations staff (excludes DE), or serve in a leadership role to a specific DM Task
With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead, providing leadership and technical expertise to Operations team
Manage delivery of projects through full data management process life-cycle
With minimal guidance, manage project timelines and quality issues, determine resource needs, and identify and justify out-of-scope
Provide input for negotiations with customer
Provide comprehensive data management expertise (including all operations tasks and DMP generation)
Perform comprehensive quality control procedures
Independently bring project solutions to the CDM team
Solves issues through using the global issue escalation/communication plan
Consult with Standards Group for process issues; communicate ideas for process improvement
Understand and comply with core operating procedures and working instructions
Thorough knowledge of the data management process
Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
Previous experience and proven competence in managing delivery of project through full data management study life-cycle (of several large phase I or at least 1 medium size Phase III)
Excellent organizational, communication, and data management skills (detail oriented)
Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification with 3 years of related experience including clinical trials experience in a function similar to DM; or equivalent combination of education, training and experience

Clinical Data Manager, Work From Home Resume Examples & Samples

Knowledge of regulatory guidelines (i.e. HIPPA, 21 CRF Part II, GCP)
Knowledge of available resources
Conflict Management
1 Year
Clinical Data Management or other relevant experience
Demonstrated success in clinical data management
Experience managing multiple teams as well as interdisciplinary teams
Experience working with and negotiating with external clients
Prior experience with case report form and data specifications creation
Prior equivalent experience in managing database systems and teams

Clinical Data Manager Resume Examples & Samples

Lead the data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure
Responsible for tracking important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in weekly meetings
Education: Bachelor’s degree required
Experience: At least 2 years of CDM experience at a pharmaceutical/biotechnology company or Contract Research Organization
Experience leading the database lock of a clinical study preferred
Computer literacy with competence in MS Word and Excel
Understanding the principles of clinical research, GCP (Good Clinical Practice), and GCDMP (Good Clinical Data Management Practices)
Logical thinking, attention to detail, good organizational skills, and problem-solving abilities
Ability to prioritize and to adapt quickly to changing business conditions plus a “can-do” attitude
Working knowledge of SAS or SQL preferred
Working experience with Excel associated with conditional formatting, complex formula, and macros a plus
Excellent understanding of CDISC data models a plus

Senior Clinical Data Manager Resume Examples & Samples

Create, organize, and track all data management documentation including project specific documentation, i.e. Protocols, eCRF competition guides, Data Management Plan and the Data Management File
Ensure that data management operations are conducted to SOPs and contribute to ongoing revision/improvement
Provide advanced leadership in data management support to create seamless project execution for all entities associated with the Global Research Initiatives supported in conjunction with the University of Arizona Health Sciences
Set-up processes for reconciliation and perform reconciliation of data from external sources (e.g. Serious Adverse Events, Central Laboratory). Produce information/reports from the clinical database
Perform User Acceptance Testing of configured databases and support/oversee data cleaning activities
Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Ensure that any recommendations are discussed and that solutions are incorporated
Provide in depth training to end users to make full and correct use of the company Data Capture systems for the collection of clinical data. Provide training and guidance to the Sr. data coordinator and data coordinator (e.g. data entry, oversight of data transfers, etc.) when needed/assigned
Bachelor’s degree in Computer Science, Computer Engineering or Life Science related field
Three years of experience in Clinical Data Management
Advanced knowledge of REDCap (Research Electronic Data Capture) and Freezerworks sample management systems
Experience with all data management processes from study start-up to study close-out
Experience working in global settings with diverse populations
Experience in data management processes specific to Nephrology and Chronic Kidney Disease clinical research projects
Experience with at least one clinical data management system (CDMS) including an understanding of database design, set-up and user acceptance testing; edit check development and/or programming and validation; management of data entry and queries; and study change control
Strong organization, written and oral communication skills

Senior Clinical Data Manager Resume Examples & Samples

A minimum of four (4) years direct data management experience, including at least three (3) years as a clinical data management project lead
Previous experience managing the delivery of multiple projects through the full data management life cycle
Thorough knowledge of the data management process (e.g., serious adverse event reconciliation, management of local laboratory data)
Knowledge of data management operating procedures and the ability to generate and apply them in practice
Knowledge of clinical research regulations including Good Clinical Practices and relevant regulatory guidelines
Working knowledge of clinical research operations, clinical trials, medical terminology, and/or pharmacology
Excellent communication, interpersonal and teamwork skills with the ability to establish and maintain effective working relationships with coworkers and collaborators
Strong project management, organization and problem-solving skills
Ability to work independently with available resources
Ability to travel up to 10% (domestically/internationally) including travel to high risk locations
Familiarity with DataFax, OpenClinica, Oracle Clinical, SAS, and R
Interest in infectious disease research

Senior Clinical Data Manager Resume Examples & Samples

Masters or Bachelor degree in Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications
The candidate should have around 6 to 7 years of data management experience and the majority of this within Pharmaceutical Industry or Development
Preferably knowledge of Clinical Development and Project Management

Clinical Data Manager Resume Examples & Samples

Assist the study lead Clinical Data Manager with data management tasks including but not limited to the following
Test and review data validation checks
Issue and resolve data queries
Review data listings and identify discrepancies based on current review specifications
Prepare and review reports
Communicate with internal and external study personnel regarding data queries
Create data management documents as directed
Assist the study lead clinical data manager with other study related activities

Clinical Data Manager Resume Examples & Samples

Participate or lead the cross-functional project team as the
Contribute to the design of protocols, forms, and data collection processes
Troubleshoot and implement solutions to issues that arise during the development, management and

Clinical Data Manager Resume Examples & Samples

Utilize, process, and analyze elements of a comprehensive data warehouse containing clinical, financial, and patient experience data and integrate them into a single analytics platform
Perform varied analyses, design and construct data visualizations, perform data validation tests, provide technical oversight
Strong understanding of analytics and statistics
Experience with relational database best practices
Strong Technical Skills in SQL Server Experience including SSMS, SSIS, SSAS, and SSRS
Working knowledge of database principles, processes, technologies and tools
Working knowledge of Extract, Transform, and Load (ETL) applications
Effective written and verbal communication and presentation skills and be comfortable presenting to all levels of client engagement (technical staff, clinical staff, managers, directors and executive teams). Ability to present key concepts to small and large audiences effectively. Ability to communicate in a group setting, concisely and at an appropriate detail level
Self-motivated; comfortable working independently under general direction
Strong negotiation skills; ability to anticipate, diffuse and/or manage conflict resolution. Ability to lead and support technical resources through tenuous situations
Excellent problem solving skills and ability to think creatively
Ability to both educate and learn from others, including technical (analysts and data architects) and others who are non-technical (e.g., clinicians, physicians, executives) client team members
Ability to adapt quickly and change direction as needed to address emergent client needs
Ability to independently learn new software tools quickly and ask for help or training when necessary
Advanced decision-making skills and ability to assimilate complex information to understand core issues, develop proposed solutions that align with VA’s methodologies and support long-term interests of the client
Ability to collaborate with study team members to prioritize the project management deliverables and understand risk and/or impact
Strong sense of customer service to consistently and effectively address client needs

Clinical Data Manager Resume Examples & Samples

Participate or lead the cross-functional project team as the clinical data management knowledge expert
Troubleshoot and implement solutions to issues that arise during the development, management and close out of clinical studies
Develop timeline for clinical data management deliverables, and ensure they are completed
Manage and/or complete all study level data management activities with a high degree of quality
Work with the Manager of CDM to create, modify and implement data management processes
Provide in-house expertise on data management related technical subject matter. (i.e. CDISC, 21 CFR Part 11, Systems validation, etc.)

Clinical Data Manager Resume Examples & Samples

Acts as Project Leader on a stand alone contract ("project") for Data Management, to include
Assists in the negotiation and contracting process with outside vendors such as e-CRF/Diary vendors, CRF Printer, and IVRS vendors
Provides project specific training for

Senior Clinical Data Manager Resume Examples & Samples

Manage and ensure CDM quality, timeline and deliverables of CROs. Specifically,
Bachelor’s degree in Science or Medical/Clinical discipline from accredited college or university, or equivalent experience required
At least of 5 years of experience in clinical data management required
Strong demonstrated knowledge of medical terminology, clinical study protocol, clinical trial process and therapeutic areas are preferred
Demonstrated knowledge of EDC Clinical databases, Interactive Response Technology, Clinical Laboratory Data, CDISC understanding, SAS dataset structure, MedDRA and WHO-Drug coding dictionaries, and Microsoft Office programs (WORD, EXCEL, POWERPOINT, etc), is mandated
Excellent written and verbal English communications skills
Proven strong detail orientation; ability to manage multiple projects, set priorities and meet deadlines

Lead Clinical Data Manager Resume Examples & Samples

As a member of the clinical study or project team, ensures oversight of the Data Management external service providers; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the external service provider
Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation, testing and implementation of data deliverables according to internal and regulatory standards
Works with team members via matrix relationships (internally or at external service providers) by directing work, resolving problems and/or providing guidance
Ensures Data Management external service providers are delivering quality data and documentation on time, on budget and to Shire’s quality standards and SOPs
Reviews Data Management external service provider performance measures and evaluates cost/benefit of actions taken to remedy or improve performance
Collaborates with external service provider and study team members to identify and resolve issues impacting goal attainment

Clinical Data Manager Resume Examples & Samples

Participate in the cross-functional project teams as the lead clinical data manager
Provide input in the design of protocols, forms, and data collection processes
Create and maintain the following study specific documents
Data Management Plans
Edit specifications
SAE Reconciliation Guidelines
Other plans and guidelines as required
Ensure documents are provided according to established timelines and SOPs
Communicate issues that affect timeline, deliverables, and/or data quality to the study team and functional supervisor
Manage and document the study specific change control process and provide realistic feedback to the study team about the impact of proposed changes
Review and provide feedback on other study specific documents
Manage all data management activities of a clinical trial in the maintenance phase of the project
Provide project specific training on electronic data capture (EDC) and other data management systems to internal and external personnel

Clinical Data Manager Resume Examples & Samples

Working knowledge of online document management system configurations
Working knowledge of SharePoint site, document library, and custom list creation
Ability to oversee projects and process improvements involving coordination with local strategic business unit managers, directors, and project controllers to ensure targets are met on time
Ability to develop specific solutions to address customer related problems and create business requirement documentation

Associate Clinical Data Manager Resume Examples & Samples

2+ years’) or equivalent combination of education, training, & experience
Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail
Ability to apply knowledge and skillsin a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
Ability to work productively with supportand minimal supervision
Ability to maintain a highdegree of confidentiality with clinical data and client's proprietary data
Strong customer focus and excellent interpersonal skills
Ability to work in a teamenvironment and independently as needed
Ability to train and direct junior team members
Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands

Associate Clinical Data Manager Resume Examples & Samples

Applies relevant components of the project protocol to daily tasks with guidance from CDM
Delivers study specific training to clinical data associates for assigned projects
Coordinates data cleaning tasks and delegates to appropriate data mangaement staff to ensure quality standards are maintained and project deliverable timelines are met
Performs specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
Monitors for risks to deadlines and escalates appropriately
Creates and maintains data management project documentation
Participates in team and client meetings and supports the lead data manager with risk management on allocated projects
Provides input into project forecasting of hours and identification of resource requirements
Monitors study metrics and runs project-specific status reports for management
Reviews data management deliverables for allocated projects following documented guidelines
Produces project-specific status reports for management, PM and/or clients on a regular basis
Ability to apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations
Ability to work productively with support and minimal supervision

Principal Clinical Data Manager Resume Examples & Samples

Several years of clinical data management experience
Must be able to set and meet timelines or be able to recognize and schedule changes in response to project demands
Ability to identify potential out of scope activities to project and CDM management and to assist with the contract modification process

Clinical Data Manager Resume Examples & Samples

Serve as the Lead Data Manager on multiple studies
Design and modify eCRFs and EDC edit checks
Responsible for building, review and validation of clinical database
Create and maintain project DM documentations
Extract and monitor the trial data to identify issues
Manage CDM activities in CRO and other vendors
Mentor or train other junior members
Minimum of BS preferably in Health Sciences, Statistics, MIS or Informatics
Minimum of 3 experience in Clinical Data Management from CROs or Pharmaceutical companies
Experience in electronic data capture (EDC) systems
Knowledge of ICH/GCP guidelines and FDA regulations
Knowledge of industry data standards (CDISC, SDTM, CDASH)
Outstanding interpersonal, oral and written communication skills

Senior Clinical Data Manager Resume Examples & Samples

Provide inputs ensure consistency of Protocols, Validation and Analysis Plans (VAPs)/Data Handling Plans (DHP) & eCRFs for all trials within assigned projects
Responsible for contributing to protocols and preparing the eCRF, VAP/DHP, database design testing (UAT), identifying errors and inconsistencies, freezing and locking database as appropriate)
To coordinate DM input and compile decisions taken to build project standards and starting knowledge sharing on those with CSU DS
Ensure work carried out under the DM Alliance is in accordance with SOP’s and Working practices and agrees deviations to the DM Alliance service level agreements for the Franchise CSU/Disease Area
May respond to Health Authority requests for data management issues
Support Expert Data Manager and other Data Managers in the team for allocated trials within assigned project(s)
Provide input, review, and maintenance of global working practices and standards
Ensure smooth and successful implementation of iDMA model, driving change and implementing new process and training
Coordinate with the Data Management Team Lead to track and report status and progress of data management for allocated trials and be proactive to ensure smooth and successful timely locking of databases
Coordinate with Team Manager within iDMA to ensure that trial is managed efficiently with high quality
Ensure appropriate Novartis tracking systems are up to date and accurate
Participate in clinical & non-clinical special projects
Assist in coaching, training and mentoring of Data Management staff
Efficient collaboration with the team from Shared Services within iDMA to ensure timely deliverables with high quality
Strong Trial Management experience required
Thorough understanding of clinical trial methodology, GCP and medical terminology
Ability to work independently, under pressure, demonstrating initiative and flexibility
Attention to detail and quality focused
Basic project management skills
Through understanding of physiology, pharmacology, clinical study objectives and the drug development process
Ability to mentor and coach within Data Management

Senior Clinical Data Manager Resume Examples & Samples

6) Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data
7) Manage partnerships with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM
8) Build standard eCRFs within the EDC system with assistance
In depth knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
Knowledgeable concerning all aspects of qualification and compliance assessments
Demonstrated ability to effectively develop and manage relationships with ESPs
Introductory technical understanding of clinical research technologies and data validation methodologies
Introductory understanding of systems integration and data interchange standards
Proficient in the use of one or more of the leading Clinical Database Management Systems
Experience supporting continuous process improvement initiatives
Current with industry developments, trends and opportunities

Clinical Data Manager, Department of Medicine Resume Examples & Samples

Create, organize, and track all data management documentation including project specific documentation, i.e. Protocols, Data Management Plan and the Data Management File
Provide advanced leadership in data management support to create seamless project execution for all entities associated with the department, center and University of Arizona Health Sciences
Develop presentations and present at Investigator meetings and training workshops associated with international clinical sites and personnel
Ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects
Three (3) years of experience in Clinical Data Management
Advanced knowledge of REDCap (Research Electronic Data Capture)
Experience in data management processes specific to clinical research projects
Master’s degree Computer Science, Computer Engineering or Life Science, Mathematics related field
Five (5) years experience in Clinical Data Management
Data and computer system information management experience, relational database knowledge, programming experience (any language), and experience overseeing personnel and projects
Experience in designing Relational Databases

Clinical Data Manager Resume Examples & Samples

Collaborate with Source Document Specialists to ensure source document templates efficiently gather all required data and satisfy clinical research documentation guidelines
Perform compliance reviews on documentation of informed consent processes
Perform compliance reviews of subject study eligibility, including documentation of study-specific inclusion and exclusion criteria
Transcribe subject study data from paper source documents to EDC systems
Provide metrics to unit managers regarding clinical team members’ performance, to be used in training to establish and maintain a very high degree of completeness and accuracy in subject source documentation and EDC data
Document and maintain metrics relating to total visit volume, sourcing errors, and data errors, to be used in analyzing efficiencies and areas of opportunity for growth
Excellent critical thinking abilities
Experienced in the use of Microsoft Office
Minimum of 2 years clinical research experience required
Minimum of 3 years’ experience in a healthcare related background preferred

Senior Clinical Data Manager Resume Examples & Samples

Knowledge of clinical research, medical terminology/disease processes and clinical practice
Technically astute with ability to understand programming logic concepts; current in areas of database preparation including database design, verification, processing, data transfer, data coding and database closing; document imaging; forms design
Familiarity with application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug
Ability to communicate well and represent data management effectively and diplomatically in a project team environment
Strong interpersonal, communication, organization, critical thinking, and problem-solving skills; able to adapt to internal/external deadlines and oversee vendors
BA/BS or equivalent in scientific discipline, nursing, health information management or computer-related field with a minimum 5 years experience in biopharmaceutical or CRO/medical/clinical data management environment

Senior Clinical Data Manager Resume Examples & Samples

Oversees all assigned clinical trials to ensure data quality, integrity and timeliness
Works closely with the Study Management Team to set study goals and objectives
Provides leadership and coordinates the activities of data management staff at the CROs
Generate data outputs for interim safety reports
Manage CDM process and assist to develop department SOPs and guidelines
Follow Company/departmental policies, procedures and SOPs
Report monthly expenditures and assist with departmental budgeting

Lead Clinical Data Manager Resume Examples & Samples

As a member of the clinical study or project team, ensures oversight of the Data Management external service providers; provides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the external service providers
Provides Data Management expertise to the team in identifying
Collaborates with external service providers and study team members to identify and resolve issues impacting goal attainment
Ensures consistent implementation of globally agreed study delivery and clinical development strategies including process and technology related to Data Management
Minimum of 5 years as a Lead Data Manager within a Data Management or service organization
CCDM certification a plus

Clinical Data Manager Resume Examples & Samples

Clinical sub-team team leader: works closely with the Clinical Trial Manager and is responsible for oversight and execution of data management activities for assigned clinical studies including data timelines and key deliverables
Responsible for executing or overseeing data cleaning activities: includes generating and managing clinical trial data queries, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events
Tracking and reporting data management project status
Works directly with and oversees CROs and vendors for Data Management services
Participation in outsourcing/vendor selection for Data Management services and software
Science background BS or healthcare degree
Experience minimum 5+ years in a pharmaceutical/biotech, CRO setting, global/international experience a plus
Strong understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO Drug

Clinical Data Manager Resume Examples & Samples

Lead study Data Manager for studies considered to be lower complexity either in terms of study design or client management
As the study data lead; be accountable for all DM deliverables per the established timeline; providing instruction to their DM study team(s) and review of their study team’s output to ensure the highest delivery quality, while adjusting resource allocations accordingly
Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs
Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at site initiation meetings
Maintain awareness of other Biometrics functional group deliverables to be able to support risk and mitigation strategies, including impact on Data Management resources or deliverables and consult with Project Manager and/or functional group management as necessary
Keep Clinical Pharmacology Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts)
Anticipates and identifies operational and logistical challenges; including mitigation plans and risk management plans and reviews them with the Project Manager, Biometrics management, and the sponsor. Executes follow-through of mitigation plans to completion in a timely manner
Coordinates the receipt and inventory of all data related information, from clinical sites and vendors as appropriate in order to meet timelines for deliverables. Ensure all appropriate documentation and procedures are performed upon project completion
Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study
Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Project Manager to ensure that Sponsor approval is received and the scope change processed
Demonstrates knowledge of DM utilized tools, systems, and processes
Ensures service and quality meet agreed upon specifications per the DMP and scope of work
Plan Data Management resources for assigned studies with support from line manager
Maintain accurate records of all work undertaken
Perform quality control on all aspects of the study as appropriate to include, but not be limited to: all study documentation, query generation and integration; to ensure that internal and client quality standards are achieved
Perform reconciliation of the clinical database against safety data, laboratory data or any other third party data as appropriate. Utilise local laboratory systems and batch data load facilities where appropriate
Perform medical and medication coding
Performs QC on all aspects of work performed in DM to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate
Support and action client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team
Actively promote Biometrics services to sponsors whenever possible

Clinical Data Manager Resume Examples & Samples

Lead study Data Manager for studies which are medium complexity including but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements
Work with the Project Manager(s) to build timelines to meet contracted milestones by communicating with leads in different disciplines and the full project team as necessary including at study initiation meetings
Provide DM project team leadership and accountability; leads data focused internal project team meetings; meets frequently with the study leads of ECD Design, SAS Programming, Statistics, and PK to ensure that all deliverables are planned and coordinated intradepartmental; proactively identifies potential risks/mitigations, effectively communicates data-driven discussions in order to achieve database lock dates; keeps the Project Manager apprised of project progress
Keep Project Manager, Biometrics management team and/or sponsor services informed of pertinent project or sponsor related information (i.e. work scope changes, timeline impacts)
Develop and maintain client relationships and review client satisfaction surveys. Implement appropriate action plans including driving process improvements and team training
Applies corrective interventions where necessary to maintain project budget compliance and profit expectations. Track scope changes and work with the Clinical Pharmacology Project Manager to ensure that Sponsor approval is received and the scope change processed
Provides leadership, mentorship, and coaching in DM related clinical trial processes, department technical capabilities, and associated turnaround durations
Have input in writing, reviewing and updating SOPs and associated documents as required
Oversee the performance of the Data Management Study team to ensure that client satisfaction is achieved through delivery of quality data, on-time and on-budget. Arrange internal or external meetings as appropriate
Attend and action client or internal audits as appropriate
Six years of combined early or late stage DM experience in DM with two years of direct sponsor management and two years of technical mentoring experience
Proven experience in handling customer negotiations and experience with managing Scope of Work and budgets
Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations
Proven ability to lead by example on project strategies and achievement of department goals, objectives and initiatives and to encourage team members to seek solutions
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies
Good organizational ability, communication and interpersonal skills
Team working skills and good collaborator skills
Constructive problem solving attitude while deadline focused with time demands, incomplete information or unexpected events

Lead Clinical Data Manager Resume Examples & Samples

Develop [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts
Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics
Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions
Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
Advanced planning and risk management for projects (issue escalation, resource management)
Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
Assist with goal creation and performance review assessment for data review project staff
Maintain technical data management competencies via participation in internal and external training seminars
Ensure project staff are trained and adhere to project-specific, global, standardized data management processes
Identify areas for process and efficiency improvement and implement solutions on assigned projects
Support achievement of project revenue and operating margin for data management activities to agreed targets
Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary
Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities
Review literature and research technologies/procedures

Lead Clinical Data Manager Resume Examples & Samples

Mentors team members, junior staff or contractors via matrix relationships (internally or at external service providers) or direct supervision, by directing work, resolving problems and/or providing guidance
Supports the development and implementation of corporate and therapeutic area standards at a study and project level
Communicates closely with Data Management external service provider contacts outside of the project and study team in order to ensure that the external service provider is acting as an extended workforce
Budgetary accountability for DM portion of trial budgets

Lead Clinical Data Manager Resume Examples & Samples

Four years’ experience in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required
Knowledge of database structures and available tools to manage, extract, and report data is preferred
Fluent Oral and written English language skills
Knowledge of applicable regulations and policies
Proficient overall working knowledge of the clinical development process

Clinical Data Manager Resume Examples & Samples

Combined early or late stage Data Management experience with direct sponsor management and one year technical mentoring experience
Proven experience of handling customer negotiations and exposure to managing Scope of Work and budgets
Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations

Principal Clinical Data Manager Resume Examples & Samples

Understanding of the tools of the trade, such as standards
Business acumen by understanding the implications of decisions from a business perspective and uses this knowledge to plan, implement and manage R&D, issues, projects and processes are aligned with business needs
Pharma, CRO and/or ARO experience. Demonstrates expertise in the identification, evaluation and selection of key global preferred provider partnerships. Ensures final contracts meet all technical and performance requirements for the appropriate business level, (asset, project or study
Demonstrates the project management

Senior Clinical Data Manager Resume Examples & Samples

The Senior Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects
S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets
Reporting to the Manager, data management this individual will
Mentor, train and supervise junior associates as needed in clinical data management processes and procedures
Independently lead a number of complex trials
Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required
Be responsible for creation of data management plans and other data management documentation as needed
Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions
Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects
Proactively organize and manages ongoing data review throughout study conduct, including being responsible for the correction of errors and discrepancies management for the life of a project
Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling
Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets
Lead efforts coordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed
Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with the project leader data standards to implement
Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner
Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times
Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer
A Bachelor’s degree in the biological sciences, Computer Science or related discipline, with at least 4 years of clinical data management experience in Medical Device, CRO or Pharmaceuticals including experience of successful active participation in cross-functional teams
Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery is required
Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc) is required
Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software is required
Experience with Electronic Data Capture (EDC), Medidata RAVE preferred
Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug) is preferred

Clinical Data Manager Resume Examples & Samples

Lead data management activities including Case Report Form (CRF) designing, database designing, developing Data Management Plan, CRF annotation, implementing edit check programs, data entry and query status tracking, and database closure
Track important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in weekly meetings
Bachelor’s degree with a minimum of 2 years of Clinical Data Management experience at a pharmaceutical/biotechnology company or Contract Research Organization

Clinical Data Manager Resume Examples & Samples

Assist Branch Chief of Data Management in implementing infrastructure for the discipline of clinical data management for FDA regulated clinical studies in human subjects
Conduct work activities in compliance with all relevant regulations and data management standards to include, CFR, ICH, GCP, CDASH-CDISCand GCDMP
Possess experience in a clinical trial environment and/or performing clinical data management activities.Possess knowledge of FDA regulations and ICH standards for design, conduct, and analysis of clinical trials

Clinical Data Manager Resume Examples & Samples

Develop and maintain a close liaison with project client contacts, core team members, and Project Managers to drive the data management aspects of project delivery
Minimum five (5) years relevant work experience in data management with approximately one
Demonstrated skill for technical management of staff exceeding 5 employees

Clinical Data Manager Resume Examples & Samples

Serve as the data management subject expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables
Design, author, develop and program as appropriate Case Report Forms, Databases, Data Management Plans, Edit Checks, Data Queries and other study specific tools and documents pertinent to the management of a clinical trial
Review and approve CRF design, data review and database design guidelines according to Standard Operating Procedures and protocol specific requirements
Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedures
Create data entry instructions and CRF Completion Guidelines
Assist in data receipt and processing, which may include printing CRF/DCF received electronically, hard copy CRF/DCFs, data entry and data reconciliation
Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity and accuracy based on project specific guidelines
Query data inconsistencies and revise case report forms in compliance with standard operating procedures, protocol requirements and regulatory agency guidelines
Generate and review reports and listings as required to maintain data integrity and reporting
Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers and interim data reporting
Assist in cleaning data for study close out and perform database lock procedures
Execute a variety of administrative tasks including but not limited to filing, printing , formatting deliverables, creating binders and other study admin tasks as warranted
Assist in developing data management process and procedure improvements
Develop and maintain study specific documentation and data management guidelines
Generate data retrievals and summaries as required
Provide accurate, timely, and consistent clinical data to internal staff to support business objectives
Define and direct the data management workflow for assigned projects, ensuring all necessary data quality control and integrity measures are in place according to plan and departmental standards and process steps
0 - 3 years of experience in Clinical Data Management
Comprehension of medical terminology desirable
Applied knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Proficient experience using commercial clinical data management systems and/or EDC products (e.g. RAVE, Inform, Oracle Clinical/RDC, etc.)
Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle)
Strong interpersonal skills, demonstrated capability of working on multiple projects simultaneously
Ability to complete deliverables on time and adjust priorities in a fast paced environment
Ability to work independently as well as collaboratively in a team environment accepting accountability

Lead Clinical Data Manager Resume Examples & Samples

Interact with cross-functional team members to provide Clinical Data Management support and ensure completion of all timelines and studies
Forge strong collaborations with Biostatistics to compile data, generate data retrievals and summaries
Contribute to the finalization of Protocols for proper data capture, including Case Report Form design. Perform thoroughly detailed reviews of CRF data requirements
Design, document, test and implement of clinical data collection using electronic data capture (EDC) systems. Ensure use of Standard CRFs, design of study specific Unique CRFs, edit check specifications, CRF Completion Guidelines (CCGs), Data Management Plans (DMPs) and/or all required data management documentations and forms for assigned studies
Develop and provide study tracking and metric reports for the project team to better monitor study progress and data quality
Proficient to perform cross-checking data Review and clean data for assigned trials. Proactively identify and implement opportunities for process improvement of assigned trials
Liaises with third-party vendors such as CROs, EDC vendors and image laboratories in a project-manager capacity in support of timelines and data-related deliverables
Participate in and/or contribute to Integra and/or Regulatory audits/inspections
Provide support as lead DM to assist Clinical Study team with PMA submissions
Provide resource to the Data Management team to create, update and maintain Integra Global Library of data standards, forms and edit checks in ClinDex by utilizing CDASH/CDISC standards
Ensure clinical data within EDC is in quality to lock/unlock as appropriate for statistical review, interim review and/or final database lock
Ensure coding is performed and reviewed. Perform external data reconciliation and specific data listings as required by the medical monitor to review safety data when necessary
Participate in Contract Research Organization (CRO) selection if required and provide independent review of CRO Statements of Work (SOW)s for data management activities and costs in contracts
Collaborate with clinical project managers to set-up and support Clinical Trial Management System (CTMS) capabilities required for specific studies
Lead development, implementation and maintenance of SOPs, working instruction, template, Data Management Plans and other activities to ensure database quality control and compliance of data management activities
Initiative and lead continue improving process of data management
Demonstrate effective time management skills and able to set priorities to meet timelines. Be able to recognize and schedule changes in response to project demands
Provide guidance and mentor less experienced Data Management professionals
Serve as a back up to Sr. Manager of Clinical Data Management
Education: Bachelor Degree in Science or Computer Science related field and/or equivalent work experience in data management may be considered
Experience: A Minimum of 5+years of working experience in the pharmaceutical, biotechnology, medical device/diagnostic or CRO setting. An experience of building study database in EDC is a big plus
Proficiency on all related regulations, GCP and Good Clinical DM Practice
Strong knowledge in CDASH, CDISC and SDTM standards
Able to use SQL or SAS or other programming/query languages; able to acquire and apply new technical skills
The preferred candidate must have strong writing, verbal communication skills, good organizational, time management skills, interpersonal and team skills

Clinical Data Manager Resume Examples & Samples

Lead internal and outsourced Clinical Data Management activities in support of Clinical Research studies
Manage the definition of Case Report Form (CRF) requirements
Create of the Data Management Plan
Coordinate the Centralized Data Review activities in support of Risk-Based Monitoring
Accountable for data integrity, quality, and consistency at Database Lock

Senior Clinical Data Manager Resume Examples & Samples

Defines and manages CDM project timelines on multiple complex studies or programs
Responsible for all the CDM study deliverables, evaluates and mitigates risks across program/s
Responsible for study and/or program resource planning
Assists in establishing CDM vendor management strategies for a program
Reviews vendor RFIs, RFPs, proposals and contracts, and provides input
Leads innovation and implementation of new technologies resulting in process improvements
Participates in and may lead cross-functional process initiatives
May supervise other Clinical Data Management staff
B.S. (or equivalent degree) in a scientific or allied health field (or equivalent degree) and 6-8 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
Proven ability to independently determine the most appropriate methods and procedures across Clinical Data Management projects
Displays highly-evolved writing and oral presentation skills that enable him/her to disseminate the importance of complex findings articulately and persuasively
Possesses highly advanced knowledge of CDM and all relevant disciplines related to the drug development process
Recognized as an emerging mentor

Senior Clinical Data Manager Resume Examples & Samples

Develops, or plans and oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, Cross- functional Data Review Plan, with input from cross-functional study team
Plans and oversees execution of User Acceptance Testing
Defines Electronic Data Transfer Specifications
Ensures study compliance with SOPs and regulations and develops study-specific training for internal and external study team
Reviews clinical study protocols and provides input
Reviews vendor RFIs, RFPs, proposals, and contracts and provide input
Prepares and delivers presentations at internal and external meetings
Oversees activities of a CDM team on multiple studies, including internal staff and vendors
Evaluates and mitigates risks to timelines and quality
Provides input regarding project resource requirements
Responsible for all aspects of the CDM study deliverables
May mentor other clinical data management staff
Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Biotech or Pharmaceutical Industry, or equivalent comparable background
Subject Matter Expert in EDC-related tools and processes
Demonstrates well-developed instincts and problem-solving skills in all areas of data management
Understands cross-functional team roles within Clinical Development
Able to provide some leadership on a cross-functional team and work effectively in a matrix environment

Program Clinical Data Manager Resume Examples & Samples

Develops strong program level standards (e.g. Protocols, DHPs/DRPs & eCRFs/CCGs) and assure adherence across trials
Develops a Working understanding of Database design principles and technology plat-forms under use
Develops an understanding of the CDISC or other recognized standards and how these impact the Programming Team
Contributes effectively to development of new CRF standards and accompanying metadata, validations, CCGs etc
Communicates and negotiates persuasively with other Program Level team members in all activities associated with development of program level standard
Supervises the study start-up, conduct & finalization for Data Management activities
Demonstrates effective application of knowledge across a wide range of DM scenarios (in-out-sourced, Paper, EDC, IIT, multi-armed etc.)
Manages effective execution of DM activities across one or more programs managing key issues that have been escalated for resolution across trials or by Program
Consistently and efficiently monitor for data trends that would be signals of potential fraud/misconduct, previously unrecognized quality concerns, or a sign of slippage in some aspect of study management
Ensures appropriate tracking systems are kept up to date
Manages communication of program wide DM status at Clinical and BDM Leadership team meetings
Supervises and drives the overall timelines/DM activities across one or more programs
Primary point of contact for DM at the Global Program Team
Responsible for training and mentoring of new colleagues
Provides the ongoing training and development of direct reports (if applicable)
Supervises individual contributors
Efficient use of resources (and resource estimation) through operational effectiveness and driving continuous improvement along with other Program Clinical Data Managers
Ensures DM associates on the program(s) are aware of the risks, priorities, goals, and impact of the work contribution
Develops risk management strategies to proactively prevent data quality issues from derailing projects
Ensures team adherence to GCP, DM standards, SOPs/WPS and process guidelines
Participates in Health Authority Inspections and responds to requests for information from Health Authorities on DM related topics
Supervises long term training activities ensuring the development of DM subject matter experts
Able to lead and provide expert opinion/input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
Collaboration with Unit Head 3rd Party Data Services in successful integration of DM Functional Service Provider (FSP) with Novartis Clinical Trial Teams (CTTs)
Manage the efficient use of resources (and resource estimation) through operational ef-fectiveness and driving continuous improvement along with other Program Data Manag-ers
Plans appropriately with Manager to ensure adherence to timelines, identifies and pro-poses solutions to address resource and timeline issues and sets priorities within the group
Participates in the interview process
Conducts the performance appraisals, career planning and development of direct reports (if applicable)
Recommends promotions and terminations to Manager
Lead or support special project within Oncology Data Sciences & Biometrics
Develops, manages, motivates, coaches and appraises the performance of direct re-ports and ensure high quality performance management across Clinical Data Manage-ment Team for assigned staff
Assists Manager in ensuring provision of timely, efficient & high quality Data Manage-ment deliverables for Global Programs within the remit of the Group for assigned staff
Track and request appropriate resources for assigned Program(s) in line with organiza-tional priorities in order to meet timelines for Clinical Data Management deliverables
Reports to Management if there are any additional demand for resources

Assistant Clinical Data Manager Resume Examples & Samples

Life science background preferable/ Experience in clinical research administration
Proficient knowledge of software packages especially Microsoft Office and commercial data entry tools, such as eCRFs
Familiar with document management procedures
Understanding of Microsoft Access preferred but not essential
Familiar with GCP and clinical study documents
Ability to appreciate and work to Standard Operating Procedures
Accuracy and attention to detail
Good level of verbal communication skills, a good team player
Proactive, motivated, enthusiastic, well organised
Quick to learn new data entry tools
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Clinical Data Manager Resume Examples & Samples

Designs and reviews the case report form, reviews annotated case report forms, and writes and reviews data management plans
Maintains the medical coding dictionaries/glossaries
Manages vendors/contractors related to data management activities
Coordinates the medical coding for adverse events, medical history, and concomitant medications
Maintains and updates MedDRA and WHO-DD dictionaries
Coordinates the SAE reconciliation between clinical database and the global drug safety database
Ensures consistency of clinical data standards across programs and therapeutic areas
Develops and streamlines the standard data management procedures
Provides expertise in the data management area to study managers, statisticians, and statistical/clinical programmers
Supports the (blind) data review and query/data reconciliations
Interacts with internal or external members of the clinical project team, including statisticians, data managers, and clinical research managers
This position requires a Bachelor’s degree in science or related field in addition to at least 5 years of related experience in CRO, pharmaceutical, or biotechnology industries
Good knowledge of the clinical drug development process. Good knowledge of both paper-CRF or electronic data capture (EDC) studies
Knowledge of MedDRA and WHO-DD and the medical coding process
Good knowledge of MS Office
Good organizational and coordinating skills
Ability to be detail oriented with attention to follow up
Ability to multitask and prioritize work

Clinical Data Manager Resume Examples & Samples

Provide oversight of clinical data management activities across multiple studies
Collaborate with cross functional Study Execution Team (SET) members and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements
Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans – identifying and mitigating risks to data quality
Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
Participate in selection of CROs and vendors; review proposals and make award recommendations
Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable
Ensure completeness, accuracy and consistency of clinical data across all assigned studies
Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel
Report query trends and data/query metrics to the study team
Review data transfers for consistency with available specifications, e.g. SDTM specifications, annotated CRFs
Lead and perform supplemental data reviews according to the data quality checks outlined in the edit check specifications document
Represent data management at Investigator Meetings and may present EDC and Case Report Forms to investigators
Implement, track and review key performance indicators on data entry, source verification, and query status; perform quality control on those metrics to ensure accuracy
Review draft TFL output prior to final database locks
Prioritize projects and coordinate data management activities in support of corporate goals and objectives
Contribute to the development of data standards in compliance with CDISC (CDASH/SDTM), and corresponding standard edit checks and data review listings
Participate in the review and/or development of SOPs and working practices

Clinical Data Manager Resume Examples & Samples

Bachelors Degree or equivalent
Understanding of local regulatory environment and commercial needs at a country level
Demonstrates the project management disciplines of planning, organizing and managing resources to bring about the successful completion of specific project goals and objectives in accordance with defined quality and time based metrics
Global clinical project level contribution, as a Data Quality Leader, Operations and Science Leader or in close collaboration with these roles and the study team. Includes working with representatives from Data Stewardship Operations and Standards
Global internal and external expert for more complex data management and data quality considerations. May be recognized as a global technical/business leader. Regularly provides expertise to others within and outside GSK
Expert input to the Study Data Quality Plan throughout the lifecycle of the study
Expert input to the development of data capture tools for a clinical study, including the eCRF and ePRO
Ensures data is of the quality and integrity from source through to submission, publication and archiving
Participates in due diligence activities and risk assessments with specific emphasis on the data management and data quality aspects for new acquisitions, in-licensing agreements and new partner relationships
Subject Matter Expert for the Data Quality Community in a specified area(s) of functional expertise, which can include expert input to the development, implementation and communication of control documents
Coach and mentor within the Practices Community

Clinical Data Manager Resume Examples & Samples

Participate in the review of Protocols for proper data capture including Case Report Form design and able to perform a thoroughly detailed review of CRF data requirements
Take a lead role to design, document, test and implement clinical data collection using electronic data capture (EDC) systems. Includes use of Standard CRFs, design of study specific Unique CRFs, edit check specifications, CRF Completion Guidelines (CCGs), Data Management Plans (DMPs) and/or all required data management documentations and forms for assigned studies
Function as Data Management representative on clinical project teams to set up, update and maintain study database up to the study closure
Lead clinical project team though data management activities achieve the timelines ensure DM delivery/timeline
Develop Cross-check data review skills and capable to program more complex edit checks to control data quality between eCRFs in EDC
Provide progress reports and data reports to the team and provide data management expertise to the team to illustrate potential issues and offer proactive solutions
Perform data review and query resolution to clean data for assigned trials. Identify errors/inconsistencies, resolve data discrepancies and inconsistency to ensure data quality
Actively participate in all required meetings and ensure timely follow-up on action items and issues
Perform reconciliation of AE/SAE data in Clinical Data Management Database with Medical Safety Department including, but not limited to, MedDRA coding and /or WHO coding
Demonstrate effective time management skills and able to set priorities to meet timelines or be able to recognize and schedule changes in response to project demands
Coordinate and communicate with EDC vendors on consistent basis to address clinical team requests related to items such as payment, report development or CTMS functionality
Coordinate the archiving of study databases and related documents, including maintenance of TMF as required
Provide oversight, monitor and track quality of CRO data management deliverables, ensuring audit practices are in place to validate the quality of EDC database content as well as external electronic data transfer
Provide input into the development of data management SOPs and processes. Write or review Data Management work instructions and SOPs
Make presentations at in-house, regional CRA and/or Investigator’s meetings to ensure understanding of data management issues
Support the training of new staff on project specific data management process
Education: Bachelor Degree in Science or Business related field and/or equivalent work experience in data management may be considered
Experience: A Minimum of 3-4 years of working experience in the pharmaceutical, biotechnology, medical device/diagnostic or CRO setting
Working knowledge of Good Clinical Practices, Clinical Research, Clinical trial process and clinical data management practices
MedDRA/WHO-Drug coding experience is desirable
Ability to build study database in EDC or use SQL or SAS is a big plus
Ability to prioritize activities and consistently meets deadlines according to accepted levels of quality, paying attention to details
Working knowledge of industry standards such as CDISC, SDTM and CDASH
The preferred candidate must have strong writing, verbal communication skills, good organizational, interpersonal and team skills

Senior Clinical Data Manager Resume Examples & Samples

Provides support to Data Managers when assistance is needed in dealing with issues regarding clients
Supervises, mentors, trains, and evaluates clinical data operations/management staff
Aids in career development and achievement of competency standards
Participates in resource allocation and recruitment based on individual skills, competencies, and availability
Manages staff utilization
Identifies and participates in the implementation of process improvement solutions
Ensures quality and timeliness of data management deliverables
Maintains consistency across a group of similar studies or within a project
Ensures SOPs are being consistently followed, and if not, that deviations are documented
Works with Project Manager to define timelines and to ensure that deliverables are provided in accordance with contracts
Acts as Strategic Operations Manager on identified projects
Serves as a helpful, tactful, professional company representative to a customer or partner under both good and adverse circumstances
Serves as a resource for other Managers and Clinical Data Managers
Presents/assists at bid defenses
Provides information for proposals Involvement in the development and execution of training programs
Participates in the selection and implementation of new data management systems and tools
Minimum 8 years' of data management experience in a pharmaceutical, biotech, or CRO environment
Minimum 2 years' of management experience in a pharmaceutical, biotech, or CRO environment
Broad knowledge of the drug development process
In depth knowledge of good data management practices
Thorough knowledge of applicable regulations such as GCP, ICH and 21CFR Part 11
Demonstrated skill with all phases of data management activities, from study start-up through database lock as a Clinical Data Manager and as a Study Builder
Demonstrated experience with a variety of data management systems, including but not limited to Medidata RAVE and Oracle InForm
Proficiency in Microsoft Office applications. SAS and SQL experience is a plus

Clinical Data Manager, / Ii-home Based Resume Examples & Samples

Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, Standard Operating Procedures and client expectations
Good written and verbal communication skills
Good analytical/problem-solving skills
Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
Ability to train and direct study team
Must demonstrate good judgment in making decisions
Ability to travel to other locations as required or as business need dictates
Strong command of English language and grammar

Clinical Data Manager Resume Examples & Samples

7) Partner with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM
Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills
Knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
Ability to interpret and apply regulatory requirements
Demonstrated ability to effectively partner with ESPs
Technical understanding of clinical research technologies and data validation methodologies
Knowledge of systems integration and data interchange standards

Principal Clinical Data Manager Resume Examples & Samples

Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Ability to recognize, evaluate and develop plans to mitigate project related risk
Ability to train and direct a study team
Ability to provide leadership and direction to both subordinates and peers
Ability to forecast project labor needed
Must demonstrate excellent judgment in making decisions
Ability to identify potential out of scope activities to project and CDM management and participate in the contract modification process

Clinical Data Manager Resume Examples & Samples

Assist with developing test cases and performing user acceptance testing of EDC systems
Assist with developing training materials, project documentation, GCP materials
Performing QC review of the data and coordinating timely corrections to the database with the clinical sites
Assist with monitoring study metrics and site performance using standard study management tools
Assist with establishing data and work flow plans
Contributing to the development and implementation of SOPs, project-specific procedures, and technical guidance documents
Develop solutions to problems where established theories and techniques have not been identified or where a precedent may not exist for procedures to be used
Assist or lead in the preparation of research grant applications and proposals by providing statistical expertise as well as writing relevant sections of the technical proposal and providing budgetary input
Assist with training and overseeing the work of junior staff, potentially serving as an administrative supervisor
Participate in efforts that enhance professional development and scientific stature
Publish findings and methodologies in peer-reviewed research journals and lead or contribute to sections of research reports
Bachelor's degree in a related and at least one year of relevant experience
A combination of performance, education and prior work experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job requirements satisfactorily
Strong IT skills, including excellent knowledge of various software programs and packages including MS PowerPoint, MS Word, Excel
Ability to work effectively both as part of a project team and independently is essential
Excellent oral and written communication skills in English
To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status

Senior Clinical Data Manager Resume Examples & Samples

Two years’ experience in clinical data management in pharmaceutical or health care clinical research environment is preferable
Self-motivated, excellent in work planning and time management
Good basic awareness of the clinical development process
Good basic awareness of clinical practice and grasp of medical terminology
Good communication skills with the ability to communicate with both technical and business areas
Proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making

Clinical Data Manager Resume Examples & Samples

Configure eCRF and databases for Clinical Trials using Oracle InForm and Central Designer (supported by Oracle Siebel Cloud), including completion of edit check programming and visit schedules
Lead Case Report Form Design and DMP development according to the protocol with all Study Team members, according to established standards (CDISC, etc.)
Perform the necessary quality control steps to confirm the study is built in accordance with approved specifications and client standards
Support any updates or changes to the study (e.g. protocol amendments); conduct change control process, and proper version control process, to production studies for both requested and approved changes
Resolve and update issues arising from UAT including study database, eCRF and edit checks
Serve as a Subject Matter Expert and point of contact for technical issues from Tier 1 support, once in production
Basic knowledge of test, debug, and implementation programming in one or more of the following is a plus: JReview, C#.NET, SQL, PL/SQL, XML, Java, Shell, SAS
Experience in fast-paced Sponsor clinical research environment
Experience working directly with biostatistics teams, including database lock and export to SAS

Senior Clinical Data Manager Resume Examples & Samples

Bachelor’s degree preferred preferably in life sciences
Minimum five years of experience in clinical research (including a minimum of three years of experience in Clinical Data Management (CDM) and/or clinical data entry) required
Experience with EDC (Electronic Data Capture) systems required
Excellent problem-solving and critical thinking skills

Principal Clinical Data Manager Resume Examples & Samples

Highly effective interpersonal skills with excellent written and verbal communications appropriate to the target audience, promoting effective decision-making where necessary
Sound understanding of the regulations (including ICH GCP) and thorough knowledge of clinical data management
Highly organised with ability to prioritise work and remain focused on objectives in rapidly changing circumstances
Conversant with the clinical trial environment and bigger picture of drug‐development
Practical experience in multiple data capture tools
Knowledge of central / local lab setup and management
Ability to identify and mitigate risks to data quality to maximise data evaluability
Excellent Leadership skills with the ability to work alone and in a team
Excellent Negotiating and Influencing skills, identifying win/win solutions
Consistent attention to detail, ability to deliver to demanding deadlines whilst maintaining the highest quality
Respiratory, Neuroscience, Dermatology and/or Immuno-Inflammation therapy area knowledge
Demonstrated experience leading in both matrix and line environment to deliver projects, and deliver clinical development plans
Ability to listen, objectively challenge and influence key stakeholders and decisions at all levels
Ability to cope with ambiguity and apply
Usage of SAS, some programming experience would be useful but not essential
Experience in the delivery of data for early phase clinical trials
Input into and maintain the Project Data Strategy Plans ensuring the development of new standards, vendor selection, data acquisition tools, technology solutions, processes, timelines and data quality aspects across all studies within a project
Act as a primary contact for Project Teams (core and extended), internal stakeholders and external parties
Ensure effective functional resourcing strategies (i.e. in-house, outsourced etc) and provide data management budget estimates as required
Develop asset level risk analyses, mitigation and contingency plans for assigned studies and projects
Lead the delivery of consistent solutions in the clinical trial data collection, validation, integration, extraction, and reporting of early‐phase Clinical Pharmacology (CP) studies within a project
Select, manage and perform oversight of vendors providing technical and data management services to the study and project teams
Project manage the delivery of fit‐for‐purpose data within single clinical studies and programmes of studies including in‐stream data delivery, database release and freeze activities
Be accountable for the data quality within single studies and/or programmes of studies
Lead the set up of data collection (eCRF, ePRO etc) and in-stream reporting tools for clinical studies within a Project
Provide data management input to the protocol, and translate the protocol into specifications for all data requirements and data types at a study or project level in line with reporting needs
Accountable for the development of the Data Validation Specification in collaboration with the study team and project requirements
Define and execute Data Quality and Protocol Deviation Management Plans, gaining study team input and applying project standards
To Interact with study monitors, site medical staff, and data providers on areas impacting data quality
Ensures peer review, completion, lifecycle management and archiving of all data management documents
Drives Cross-Project Data Management collaboration, sharing information and lessons learnt as a Data Management expert within the Data Management Community
Responsible for appropriate communication of data management deliverables to the study and project teams
In partnership with study team, responsible for delivery of data management contributions to regulatory submissions as required
As required, identify, participate and/or lead process improvement initiatives
Train, coach and mentor staff as required completion of specific project goals and objectives in accordance with defined quality and time based metrics

Senior Clinical Data Manager Resume Examples & Samples

Be able to lead a large clinical study or a series of related studies with minimal guidance
Represents Data Management on the CTWG for assigned studies
Provide leadership, mentoring, and training to lower level Data Management staff assigned to his/her studies
Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design
Be able to perform a thoroughly detailed review of eCRF data requirements
Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines
Lead the development of data edit check specifications and data listings
Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
Develop or lead the development of the Data Management Plan for a clinical study
Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
Perform reconciliation of header data from external data sources against the clinical database
Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
Lead database upgrades/migrations including performing User Acceptance Testing
Be able to maintain study workbooks and data management files
Perform database lock and freeze activities per company SOPs
Participate in regular team meetings and provide input when appropriate
Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents
Contribute to a professional working environment including the application of Jazz Pharmaceuticals Code of Business Conduct and Ethics
Assist with the training of new employees and/or contractors
At least five years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
Has good project management skills and a proven ability to multitask
Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform most of the core Data Management tasks and interact with vendors
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Possesses strong English language written and verbal communication skills
Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are preferred
Able to travel to off-site meetings or training seminars as needed
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems. Experience with Rave or InForm is preferred
BA/BS, preferably in the scientific/healthcare field

100

Senior Clinical Data Manager Resume Examples & Samples

Review and understand protocol synopsis and attend if required any protocol review meetings and act as subject matter expert for proper data capture based on protocol requirements
Lead Case Report Form Design according to the protocol with all Study Team members using established standards
Author or review CRF completion guidelines
Develop or lead in the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, CRF flow, data queries, manual checks, coding, SAE reconciliation, third party vendor reconciliations, specification of data listings needed to facilitate data cleaning in accordance to a Data Review Plan, data lock and archiving, etc
Develop and test edit specifications which may include the development of test scripts used for UAT as well as perform/coordinate UAT testing
Ensure coding has been performed and reviewed by Medical Coder,
Perform external data reconciliation, provide data management related metrics, provide specific data listings as required by the medical group and review when necessary
Make data, including interim data, available to company personnel and to regulatory agencies when required
Trouble-shoot database issues with DBA until resolution is obtained
Prepare and present data collection requirements at Investigator Meeting
Participate in CRO selection
Review SOWs for data management activities and costs in contracts
Interact with physicians, scientists, monitors, programmers, study managers and statisticians in creating an appropriate database, data quality assurance, and resolution of data queries
Assist in database upgrades/migrations including performing User Acceptance Tests
Serve as the DM representative on clinical project teams that are developing NDAs

101

Senior Clinical Data Manager Resume Examples & Samples

Plans, coordinates, and manages data management tasks and clinical studies timelines
Acts as primary liaison with CROs, third party data vendors, and EDC vendors
Reviews clinical protocols, initiates RFPs and reviews vendor proposals
Primary author/reviewer for CRFs/eCRFs, CCGs/eCCGs, and Data Management Plans
Build EDC clinical studies and/or direct the vendor to build clinical study systems
Perform sponsor review or complete clinical study systems’ UAT testing
Collaborate with clinical study team on the implementation of clinical study systems
Ensures Data Management Plans are followed throughout the course of the studies
Accountable for external data vendor documentation, management, and reconciliation
Responsible for ensuring clinical study documentation is securely stored
Contribute to departmental process improvement and integration of technology
Perform and/or review Coding and SAE reconciliation
Provides comprehensive status updates to project team members
Prepare material for and present at Investigator Meetings

102

Clinical Data Manager Resume Examples & Samples

Applies relevant components of the project protocol to daily tasks and directs others on how to apply to their daily tasks
Acts as an interdepartmental and client liaison for all DM study activities
Produces project-specific status reports for CDM management, PM and/or clients on a regular basis
Monitors and analyzes study metrics and escalates per the PPD risk management processes
Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required
Assists with project forecasting of hours and identification of resource requirements
Assists with the oversight of project budgets including identification of out of scope work and participation in the Contract Modification process
Leads, high volume/highly complex studies
Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget
Mentors junior level staff on all associated tasks within a study
Assists with administrative and financial oversight for allocated projects
Communicates with management regarding all data management activities within their studies
Identify potential out of scope activities to project and CDM management and to assist with the contract modification process
Ability to work productively in both a team environment and independently as needed
Ability to direct and train study team
Ability to support project resourcing and project timeline planning and adherence to timelines

103

Clinical Data Manager Resume Examples & Samples

Responsible for data management activities for all protocols including assisting Manager, CDM with prioritizing workload and activities as well as leading data management activities for one or more protocols
Responsible for UAT of newly developed databases
Responsible for documenting UAT and validation of new EDC system (eClinicalOS Merge)
Responsible for CRF and study document control and archival standards
Responsible for SOP and Work Instruction development and enforcement
Responsible for the development, and implementation of standards across all studies for DMP, edit checks, CRF modules, etc
Responsible for development of the processes for collecting and organizing clinical study data
Recommends and implements systems to improve quality and efficiency
Serves as liaison to core team for clinical data management related issues
Ensures project execution according to timelines set by core team
Ensures that analyses, listings, graphics, and reports are accurate and complete for regulatory submissions & scientific publications
Recommends and initiates systems to improve quality and efficiencies
Researches and recommends the use of new technology approaches
Advises clinical scientists regarding design and organization of clinical data
Develops edit checks and writes SAS programs
Experience developing eCLinicalOS Merge
Expert knowledge of clinical data management principles and GCPs
Expert knowledge of systems used to manage clinical data
Advanced understanding of Clinical Study process, including study design, conduct, management and data analysis
Programming experience in any or all of SAS, SQL or C#
Degree(s) in Life Sciences or Mathematics
BS/BA with 5 - 8 years of experience
MS/MA with 3 - 5 years of experience

104

Principal Clinical Data Manager Resume Examples & Samples

Trial Data Manager (TDM) for complex trials or as subject matter expert of CDM responsibilities and processes e.g. TMCP process expert
Project Data Manager (PDM)
Risk Based Quality Management (RBQM) Business Partner (BP)
In the role of a Trial Data Manager (TDM) for complex trials or as subject matter expert of TDM responsibilities and processes for clinical trials led in-house or using business process outsourcing (BPO)
Takes a leadership role as subject matter expert for CDM responsibilities and processes in global projects/working groups and provides mentoring for less experienced Data Managers (DMs)
Takes a lead role in the specific setting of special trials, like mega trials or complex TMCP trials. Existing SOPs, guidelines and WIs do not cover these and the trial CDM has to make sure that the processes are developed according to the trial’s needs but adheres to the principles of GCP and other regulations like FDA guidance / regulations and documented in SOP variations as necessary
Takes a lead role with internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
Responsible for CDM trial level oversight
Builds effective relationships with vendor partners
Review protocols and identifies requirements for proper data capture
In the role of a Trial Data Manager (TDM): Continued…
Oversee the design, creation and UAT Plan and testing of clinical study databases along with development of edit check specifications and manual data listings as required
Define or reviews creation and maintenance of all essential data management documentation including CRF specifications, eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans (detailing complete data management processes throughout clinical studies), Data Transfer specifications and Data Review Guidelines, in accordance with the protocol, BI and project data standards
Integrates external data (non-CRF data) from vendors or other internal departments into the clinical trial database
Establishes conventions and quality expectations for clinical data and plans and tracks the content, format, completeness, quality and timing of the trial data collection process and other CDM deliverables via data analytics throughout the conduct of a trial
Throughout the trial, the function holder leads the respective trial level activities in the context of business process outsourcing (BPO) in CDM
Collaborates with the trial team to ensure that the database can be locked according to the planned timelines and quality. Responsible for the database lock and accountable for the integrity of the database
Ensures that SDTM (Study Data Tabulation Model) compliant data is available for analyses together with the Project Data Manager (PDM) and the SDTM programmer at the CRO (in the context of the BPO)
Leads and facilitates the Medical and Quality Review (MQR) process and other trial team meetings. Presents and trains at trial team, CRA and investigator meetings
Ensures real-time inspection readiness of all Clinical Data Management deliverables for a trial and participates in regulatory agency and BI internal audits as necessary
Identifies and communicates lessons learned and best practices at the trial level and within CDM. Identifies and participates in DM related process, system, and tool improvement initiatives within CDM/BDS
Leads trial data managers in support of their trial in aspects of the data management work
In the role of a Project Data Manager (PDM), the function holder performs PDM tasks for multiple early stage project e.g. PDM TMCP or for an international development project that has gone beyond the stage of Proof of Clinical Principal (PoCP) and involves complex and large international phase III trials
Builds effective relationships with CROs/ vendor partners utilized within the project
Gives input to the core clinical trial protocol (CTP)
Defines, reviews and approves key Clinical Data Management Project level deliverables, including: Core Case Report Form (CRF) design, instructions for CRF completion, Project data management plan; e.g. database specifications including derivations, edit check specifications, data cleaning plan, Electronic data transmission agreements in accordance with the core protocol , BI, TA Level data standards and Project needs
Initiates and compiles PDMAP documentation containing the necessary CDM / Biostatistics & Data Sciences (BDS) documentation for a project together with other members of the trial team as appropriate. Therein ensures appropriate quality, scientific content, organization, clarity, accuracy, format, consistency and compliance with regulatory guidelines. Ensures that SDTM (Study Data Tabulation Model) compliant data is available for analyses together with the Trial Data Manager (TDM) and the SDTM programmer at the CRO (in the context of the BPO)
The PDM sets up, maintains and validates the project database consistent with the latest industry, BI and project standards. Ensures that the SDTM project database is compliant with the requirements from the project statistical analyses plan and collaborates with the PSTAT, PPROG on a regular basis
Establishes conventions and quality expectations for clinical data and plans and tracks the content, format, completeness, quality and timing of the project database via data analytics throughout the conduct of a project
Compiles and ensures compliance of all elements of the electronic submission deliverables: (e.g.): datasets, trial level SDTM Reviewers Guide and define.xml
As part of inspection readiness, the PDM ensures that the TDMAP documentation of the pivotal trials is complete and consistent and communicates with trial data managers during conduct of these trials to set expectations
Identifies and communicates lessons learned and best practices at the project level and within CDM. Identifies and participates in DM related process, system, and tool improvement initiatives within CDM
Leads / mentors project/trial data managers that support the project in aspects of the data management work
In the role of a Risk Based Quality Management (RBQM) Business Partner (BP), the function holder performs RBQM BP tasks for one or multiple clinical trials
Leads the project or trial team through the process of identifying and assessing risks at the beginning of a trial
Initiate and facilitates the RBQM risk review and assessment meetings,
Develop and maintain trial specific Risk Based Quality Management (RBQM) documentation and assists with any risk related questions that arise
Authors the quality statement / Quality Report at the conclusion of the trial - for the Clinical Trial Report
RBQM mentor / trainer for Central Monitors (CM), new RBQM BPs and other trial team members e.g. CRAs, CMLs
RBQM BP may also perform CM tasks as needed
Supports the development, and maintenance of RBQM tools

105

Clinical Data Manager Resume Examples & Samples

Trial Data Manager (TDM)
Central Monitor (CM)
Or developing expertise and capabilities under supervision as
Project Data Manager (PDM), as an associate PDM or supporting a local submission (e.g. in Japan or China)
Risk Based Quality Management (RBQM) Business Partner (BP), e.g. as an associate RBQM BP or for a trial of low complexity
In the role of a Trial Data Manager (TDM) for clinical trials led in-house or using business process outsourcing (BPO)
Key liaison / Data Management lead to establish, align and confirm data management expectations for assigned trial(s), this requires regular interaction with other internal and external partners e.g. TCM, TSTAT, TPROG, TMCP, BPO partners
Responsible for CDM trial level oversight. Builds effective relationships with CROs/ vendor partners. Review protocols and identifies requirements for proper data capture including electronic Case Report Form design and processing of clinical data ensuring accuracy, consistency and completeness
Initiates and compiles Trial Master File (TMF) relevant documentation containing the necessary CDM / Biostatistics & Data Sciences (BDS) documentation for a trial together with other members of the trial team as appropriate. Therein ensures appropriate quality, scientific content, organization, clarity, accuracy, format, consistency and compliance with regulatory guidelines
Throughout the trial, the function holder either performs or leads the respective trial level activities in the context of business process outsourcing (BPO) in CDM
Leads and facilitates the Medical and Quality Review (MQR) process and other trial team meetings. Presents and trains at trial team, CRA at investigator meetings
Ensures real-time inspection readiness of all CDM deliverables for a trial and participates in regulatory agency and BI internal audits as necessary
Identifies and communicates lessons learned and best practices at the trial level within CDM. Identifies and participates in DM related process, system, and tool improvement initiatives within CDM/BDS
In the role of a Trial Data Manager (TDM) for fully outsourced trials, supervises and instructs the CRO in performing the above TDM tasks and leads trial level oversight, including planned timelines and fulfillment of quality expectations
Sets expectations for and defines specifications for data transmission with the CRO. Integrates the data from the CRO into the BI clinical trial database. Ensures that SDTM compliant data is available for analyses together with the responsible Project Data Manager (PDM)
In the role of a Central Monitor (CM) for clinical trials
Executes and manages the Risk Based Quality Management (RBQM) processes as described in the monitoring framework, this requires regular interaction with other internal and external functions e.g. clinical monitors, CRAs/site monitors, data managers, biostatistics, site personnel
Conduct root cause analysis on the risk signals of aggregated site and trial data (pulled from various sources) using risk reports. Identifies and investigates potential risks and trends with subject protection and reliability of trial results and compliance with the investigational plan for impact on site/country/trial activities
Provides direction to site monitors for additional remote and on-site monitoring activities for risk sites, within the scope of the trial monitoring plan
Oversees potential issues and findings requiring further review and follow-up and ensures appropriate actions are taken by the trial team members to investigate, resolve and document potential risks identified, including adequate documentation of resolution
Provides a regular and efficient mechanism of trial communication for the trial team including documentation and leads oversight meetings
Ensures real-time inspection readiness of responsible RBQM deliverables for a trial and participates in regulatory agency and BI internal audits as necessary, in conjunction with the RBQM BP
Identifies and communicates lessons learned and best practices at the trial level and with other CMs. Identifies and participates in CM related process, system, and tool improvement initiatives within CDM/BDS. Performs user acceptance testing and supports the development and maintenance of RBQM tools
In the role of a Project Data Manager (PDM), the function holder performs (selected) PDM tasks under the supervision of an experienced PDM, e. g. as an associate PDM or for a project of low complexity where existing standards, material and documentation can be re-used and built upon
Accountabilities include the definition, leadership and oversight of data management processes and deliverables for clinical projects (with one project comprising multiple trials in a substance in one indication) such as establishing expectations for CRF-based/external dataset content and structure, definition of project standards (e.g. SDTM, CRF, specifications such as for MQR, data cleaning, data transmission), review and acceptance of project level database elements, programming and validation of the project database (PDB), preparation and creation of CDM deliverables for regulatory submission and support of safety updates
Alternatively, the function holder may be responsible for the specific CDM deliverables and support for a local regulatory submission (e.g. in Japan or China)
In the role of a Risk Based Quality Management (RBQM) Business Partner (BP), the function holder performs (selected) RBQM BP tasks under the supervision of an experienced RBQM BP, e.g. as an associate RBQM BP or for a trial of low complexity
Takes a leadership role with the project / trial team to establish, align and confirm RBQM expectations for assigned trial(s). The function holder performs (selected) RBQM BP tasks in the definition, leadership and oversight of Risk Based Quality Management (RBQM) processes and deliverables for one or multiple clinical trials such as guiding the project and trial team through the process of identifying and assessing risks at the beginning of a trial, initiating and facilitating RBQM risk review and assessment meetings, facilitating the implementation of required RBQM documentation and tools, authoring the quality report and assisting with any risk related questions that arise

106

Clinical Data Manager, Scharp Resume Examples & Samples

Consistent, dedicated, versatile and able to prioritize and multi-task
Self-motivated and able to work independently using strong organizational, project and time management skills
EDC experience required
Demonstrated expertise in relevant clinical data management activities
Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
Proficient with MS Office software
Experience with managing immunology, infectious disease and/or virology research projects
Experience in HIV or infectious diseases clinical trial operation management and/or protocol development

107

Clinical Data Manager Resume Examples & Samples

Develop clinical study data specifications, including CRF design, user requirements, edit rules/checks and query logic
Provide clinical data management support for study operations and analysis groups
Experience with validation of EDC systems from a study level (not IQ/OQ validation, more PQ for individual studies). Should have experience creating study requirements, test cases, and UAT documentation
Experience with clinical data transfers between systems and creation of Data Transfer Agreements (DTAs) between external data sources
Administration of existing EDC systems for multiple studies
Training users to user EDC systems. Includes create of training documentation and running training sessions for end users
Ideally this person will have medical knowledge as pertaining to medical devices for surgery. This will help to understand CRF design and purpose and interpret Study manager/protocol requirements to efficient EDC design
2-5 years of experience building EDC study/CRFs. Bachelor's degree in Science, Computer Science, Engineering or related field
Experience with ClinCapture EDC system a plus
Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
Working knowledge of Clinical database applications such as EDC and CTMS

108

Senior Clinical Data Manager Resume Examples & Samples

Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail
Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems
Experience with SAS (Base, Stats, Macro, etc.)
Experience with CDISC SDTM/CDASH
Experience with study database build (including edit check programming)
Experience in software development, software implementation, testing and validation
Participate in project meetings as subject matter expert and to give a status update to project managers and upper management
Assist in preparation of study material for investigator, study coordinator, and monitor meetings

109

Clinical Data Manager Resume Examples & Samples

Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met
Responsible for completeness, timely delivery, and quality of clinical trial data
Participate in vendor evaluation, qualification, and selection, as needed
Anticipate data management project requirements, institute, and manage appropriate actions to ensure timelines and project goals are met
Serve as DM representative at study team meetings and as primary contact for internal departments and external vendors; provide status reports
Provide oversight of designated activities outsourced to CROs, external consultants, central and specialist labs, and other vendors
Participate in protocol design/review and CRF design/review (paper or eCRF)
Perform data review for quality issues and general data trends
Develop or review Data Management Plans
Define or review Edit Check Specifications; test edit checks
Develop User Acceptance Testing (UAT) plans, coordinate, and participate in UAT
Develop or review CRF Completion Guidelines, Manual Review Guidelines, Data Entry Guidelines
Review electronic case report forms (eCRFs) or paper CRFs for completeness and content, when applicable
Generate, process, track and resolve queries, when applicable
Review coding and ensure coding is complete and approved by Company Medical
Review or perform external data reconciliation, SAE reconciliation
Understand and follow SOPs. Review and contribute to DM SOPs
Ensure compliance with all applicable laws, regulations, and regulatory guidelines
Available for periodic travel (~15%) including overnight stays, when required
Ability to drive and have a valid driver’s license
University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology
Minimum 5-years of relevant pharmaceutical, biotech, or CRO experience in data management
Must be proficient in all aspects of data management from study start-up to study close
Knowledge of medical terminology, coding processes using MedDRA and WHO Drug, and database design and concepts
Working knowledge of ICH, FDA, GCP, HIPAA, GCDMP regulations and guidelines, as well as CDISC – CDASH standards, and SDTM/ADaM datasets
Excellent organizational skills with great attention to detail and the ability to multitask
Excellent verbal and written communication skills, as well as oral presentation abilities
Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments (e.g. Regulatory, Clinical Operations, Clinical Research, CMC, Pre-Clinical, Stats)
Ability to work proactively and effectively in a fast paced, high change environment
Flexible; adapts to work style to meet organization needs
Demonstrated initiative and resourcefulness
Ability to mentor/train/supervise junior staff or their work
Ability to represent Company in a professional manner
Assumes responsibility and accountability for results
Proficient computer skills including MS office products

110

Clinical Data Manager Resume Examples & Samples

M.Sc / B.Sc in Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications
Preferably 2-3 years of data management experience and the majority of this within Pharmaceutical Industry or Development
Preferably 2 years of experience in Information Technology
Preferably knowledge of Clinical Development
Preferably experience in project management, stakeholder management and presentation skills

111

Clinical Data Manager Resume Examples & Samples

Coordinate Case Report Form (CRF) development, review and approve final CRFs
Review and approve data entry screen shots during database development processes
Develop data entry metrics and work closely with the Clinical Study Manager (CSM) to allocate resources based on priorities
Create edit checks for each clinical study database
Coordinate the data entry process
Oversee data entry quality control, create worksheets, review findings, calculate error rates and approve quality control report
Coordinate all cycles of data management during data review and generate data discrepancy criteria
Review listings for quality, content, format and output
Participate in X-ray review and ensure quality of process
Oversee and conduct X-ray quality control on a quarterly basis
Work in collaboration with Clinical Study Manager (CSM)/Clinical Study Associate to assure timely study development and clinical data reports
Supervise the locking process of study database and sign off approval
Review SAS program specifications and perform UAT when appropriate
Design and/or participate in design of data management documentation and SOPs
Participate in preparation and presentation of data management activities and new initiatives
Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiatives

112

Senior Clinical Data Manager Resume Examples & Samples

Minimum five years experience in clinical research required
Minimum of three years experience in Clinical Data Management (CDM) and/or clinical data entry) required
Proven expertise in Microsoft Office Suite

113

Senior Clinical Data Manager Resume Examples & Samples

Knowledge of data management technology
Knowledge of budgets and the budget process
Time management skills
Ability to translate ideas into action
Ability to think strategically
Ability to work independently to achieve goals
Must have initiative and excellent follow through
Ability to influence peers
Clinical Data Management experience in clinical research industry (sponsor/CRO/biotech or combo)
Leadership experience, managing a project or a team
Technical experience with Data Management tools

114

Program Clinical Data Manager Resume Examples & Samples

Develops a Working understanding of Database design principles and technology platforms under use
Manage the efficient use of resources (and resource estimation) through operational effectiveness and driving continuous improvement along with other Program Data Managers
Plans appropriately with Manager to ensure adherence to timelines, identifies and proposes solutions to address resource and timeline issues and sets priorities within the group
Develops, manages, motivates, coaches and appraises the performance of direct reports and ensure high quality performance management across Clinical Data Management Team for assigned staff
Assists Manager in ensuring provision of timely, efficient & high quality Data Management deliverables for Global Programs within the remit of the Group for assigned staff
Track and request appropriate resources for assigned Program(s) in line with organizational priorities in order to meet timelines for Clinical Data Management deliverables

115

Assistant Clinical Data Manager Resume Examples & Samples

Serve as Data Team Lead (DTL) on multiple global clinical trials or 35+ increasingly complex central laboratory studies
Provide leadership to CDM team
Manage CDM customer relationship for CDM project team including active participation in DM customer negotiation on timeline, budgetary and other issues (with guidance)
Or serve as Data Operations Coordinator (DOC) for one or two global clinical trials with fewer than 20 operations staff (excludes DE) or 20-30 central laboratory studies, or serve in a leadership role to a specific data management task
With minimal guidance, serve as back-up for Data Operations Coordinator or Data Team Lead
Provide leadership to Operations team
Provide specific CDM task or technology expertise
Provide comprehensive data management expertise (including all operations tasks and creation of project specifications)
Develop and maintain good communications and working relationships with CDM and project teams
Knowledge of Medical Terminology, Pharmacology, Anatomy, and/or Physiology
Data Operations Coordinator (DOC)
Clinical Data Coordinator (CDC)
Lead Coder
Coder
Coding Reviewer
Technical Designer (TD)
Validation Team Lead (VTL)
Validation Team Member (VTM)
Data Administrator (DA)
Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification; with 3 years of related experience including clinical trials experience in a function similar to data management; or equivalent combination of education, training and experience

116

Clinical Data Manager Resume Examples & Samples

Review study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans
Monitor the activities of CRO DM functional counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with study milestones/timelines and with quality
Participate in the review of clinical study protocols and Mock Tables, Figures and Listings (TFL) shells
Support data management activities in alignment with corporate goals and objectives
Participate in the review of SOPs and working practices

117

Clinical Data Manager Resume Examples & Samples

Manage regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies; For assigned products, contribute to and provide review/approval for safety aggregate reports as required locally
Direct liaison with Health Authorities to facilitate the prompt review and approval of applications, supplements, and commitment closures
Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products
Lead and/or direct creation or revision of labeling per Pfizer’s medical position or as instructed by Health Authority
Develop and implement regulatory strategies to support/maintain registrations. Maintain product licenses across all product platforms
Understand regulatory environment and communicate priorities to global/regional stakeholders
Deliver project regulatory strategy, risk assessment, and PRS for assigned projects/products
Ensures business compliance and implementation of and adherence to Regulatory standards
Lead and/or direct team discussion regarding project status in senior management forums
Prepare IRD and CTD submissions for NCE and line extensions including liaison with contributing groups and review of components. Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, minimize resource demands while maximizing overall project delivery time and probability of success
Ensure that product maintenance activities (product renewals, AQRT's, regulatory queries, etc.) are managed and responded to in line with product role, consistent with departmental procedures an including liaison with other functional groups to ensure that response targets are met
Liaise with internal and external technical experts responsible for preparation of expert documentation for inclusion in IRD and CTD submissions and apply regulatory expertise to enable preparation of high quality documentation
Advise on the development of regulatory documentation that meets relevant regulatory requirements and ensure that the documentation meets relevant regulatory requirements and that compliance with departmental procedures is assured
Co-ordinate with regional and country strategists the receipt, distribution and response to regulatory queries, in line with product role, consistent with departmental procedures and including liaison with RRT members to ensure that response targets are met
May lead preparation for, and attend where appropriate, meetings with regulatory authorities, including preparation of background materials, logistical organization and assisting in preparation of meeting minutes
Ensure that comprehensive records of communications and regulatory status are maintained
Proven examples of delivery across a product’s lifecycle with demonstrable contribution in Regulatory Affairs
Regulatory experience including knowledge of NDA/IND, 505(b) (2) submission processes
Experience managing multiple products simultaneously and different stages of the product lifecycle
Experience in successfully communicating with major Health Authorities, including leading and participating in such interactions
Proven ability to consistently deliver to time, cost and quality standards

118

Clinical Data Manager Resume Examples & Samples

4-6 years relevant work experience in data management with approximately one year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas
In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
Working knowledge of relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies
Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solution
Demonstrated managerial and interpersonal skills

119

Clinical Data Manager Resume Examples & Samples

Respond to requests in a timely manner, give/receive correct information, encourage required dialogue/follow-through
Completes filing in accordance with department procedures. Duplicates and collates materials upon request
Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study
Review all the elements of the screening process with the Principal Investigator
Collaborate with various personnel that may be involved in assisting with specific aspects in the study. Interact, if needed, with patient/subject and families in a courteous and professional manner
Utilize available resources and established procedures to identify problems for quick resolution
Reviews data with supervisor and provides reports to the data and safety monitoring committee
Responds to requests in a timely manner, gives and receives correct information, encourages required dialog and follow through
Follows-up to ensure that requested materials are delivered according to all appropriate procedures and policies
Utilizes the necessary tools to ensure protocol compliance to conduct direct data research
Utilizes established methodologies to collect patient information for the research project(s)
Extracts data for publications, or provides data collection from outside physicians offices
Formats and uses tools to facilitate data collection (e.g., calendars, schedules, tracking logs, etc.)
Compiles data and assists in consolidating and analyzing data for presentation to sponsoring and regulatory agencies
Reviews any issues that deviate from standard policy and procedure with supervisor
Reviews data with supervisor and then provides reports to all parties (e.g., data and safety monitoring committee, the principal investigator, sponsoring agency, etc.) on the progress of the study
Completes report forms and records following set protocol from the beginning of a research/study through the end
Utilizes appropriate sources, gathers and compiles data, statistics and other materials as needed
Inputs clinical and non-clinical data into the database and or case report forms; ensures data entered is correct and consistent with the source document and completed in a timely and organized manner
Suggests changes and additions to established data fields as needed, to supervisor
Processes incoming and outgoing documents by transcribing data, figures, statistics, codes and other information
Completes paperwork and forms in a neat, accurate, timely manner and ensure subsequent data collection as required
Reviews data to be entered, edits obvious errors and obtains missing information
Prepares requested data and numbers thoroughly and accurately for statistical analyses and required reporting
Ensures that information in computer database is accurate, entered and maintained on a timely basis
May perform library searches and retrieve reference materials from various sources using Medline and PubMed
May request articles from medical journals
May prepare presentation for lectures and symposium, utilizing PowerPoint for slides
Coordinates, Facilitates and Communicates with Staff and Non-Staff to Produce Required Results
Interfaces with varied persons, such as, School of Medicine and or Medical Center staff (e.g. physicians, nurses, CTO)
Recognizes and identifies problems, appropriately escalate issues to supervisor as needed
Utilizes available resources and established procedures in order to rectify problems, communicates all changes
Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visit

120

Clinical Data Manager Resume Examples & Samples

Develop and review data management procedures for clinical trials with sponsor companies and other departments
Manage projects; and
Coordinate overall data management by serving as primary contact for the sponsor, external data providers, and all project team members
Bachelor’s degree and at least three (3) years of Data Management experience
Computer experience with database, spreadsheet, and analysis software (i.e. SAS&sup®&sup,Oracle Clinical, and SQL preferred)
Possess an understanding of database structure and computer storage in data management; and
A basic knowledge of medical terminology is needed, as well as knowledge of a scientific investigative methodologies and clinical research methodologies

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