Clinical Data Management Resume Samples

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R Huels

Roxane

Huels

5161 Borer Plains

San Francisco

+1 (555) 713 4478

5161 Borer Plains

San Francisco

Phone

p +1 (555) 713 4478

Experience Experience

San Francisco, CA

Director, Clinical Data Management

San Francisco, CA

Hahn, Lynch and Hagenes

San Francisco, CA

Director, Clinical Data Management

Responsible for hiring, training, development and management of staff; ensures effective resource allocation
Leads Data Management personnel through audit situations, including closing out audit findings
Create, review, and update CDM processes and Standard Operating Procedures
Collaborate with Biostatistics and Programming to help build the Biometrics function at Avanir
Leads and oversees Clinical Data Management function and EDC programming (through external vendors)
Develops departmental policy, standard operating procedures, and work instructions
Willing to maintain regular office hours in either our Secaucus or Somerset, NJ offices

Philadelphia, PA

Associate Director Clinical Data Management

Philadelphia, PA

Berge Inc

Philadelphia, PA

Associate Director Clinical Data Management

Represent Clinical Data Management at cross-functional forums, meetings and provide timely feedback to partners
Lead and support clinical & non-clinical special projects
Provides all necessary support to address any issues requiring management input
Represents the group in any forums including leadership team meeting to address issues. Ensure process improvements suggestions are evaluated and support team to bring suggestion to management for consideration
Provides management oversight for all the activities for Clinical Data Management during study startup
Authorizes the GoLive based on a review of completion of all activities for pivotal trials
Provides management oversight for all the activities for Clinical Data Management during data finalization

present

Phoenix, AZ

Associate Director, Clinical Data Management

Phoenix, AZ

Quitzon-Mosciski

present

Phoenix, AZ

Associate Director, Clinical Data Management

present

Assists in the training of other Clinical Data Managers or CDM associates through mentoring or developing/conducting training
Work closely with Statistics & Programming to ensure high quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc
Contributes to back-end project budget/resource planning, re-forecasting, program milestones, along with CPMs and Clinical Operations management
Project team development, resource planning, and cost estimating
Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
Communications planning, information distribution, performance reporting, and project closure
Ensures projects are conducted in compliance with operating procedures and good clinical practices

Education Education

Bachelor’s Degree in Collaboration With

Florida Atlantic University

Bachelor’s Degree in Collaboration With

Skills Skills

Strong leadership skills and ability to work within cross-functional teams
Proven ability to manage multiple projects, set priorities and meet deadlines
Excellent interpersonal, organizational, and multi-tasking skills
Ability to work well on a team and independently
Excellent MSOffice skills including Word, Excel, PowerPoint, Outlook
Excellent written and verbal English communications skills, including presentation skills
Demonstrated strong technical and problem solving skills
In-house position based in Waltham, MA
Demonstrated team management skills
Travel domestic and international – up to 15%

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15 Clinical Data Management resume templates

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Senior Director, Clinical Data Management Resume Examples & Samples

Lead the design and implementation of an Enterprise Data Management capability, including
Bachelor’s degree or equivalent required, preferably in the Life Sciences, e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy. Advanced degree is preferred
Minimum of 12 years of experience in the pharmaceutical industry, at a CRO or hospital, including extensive clinical research experience
Experience in Clinical Data Management is preferred
Must have the ability to maintain and improve consistent and sound business processes in a dynamic, cross-cultural environment
Must be able to work in a fast paced environment in a global team utilizing multiple communication styles and venues to manage staff and/or business partners in different locations and time zones
A proven track record of people and project management
Ability to manage complexity and multiple priorities in a matrix environment under pressure
Proficient in English language
Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint)
The position may require up to 25% travel, including both domestic and international

Director, Clinical Data Management Resume Examples & Samples

Line management responsibilities for staff members. Approves courses of action on interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods. Drives recruitment of operational staff
Manages resource management and maintaining utilization/realization at acceptable levels. Ensures that all projects maintain the correct level of gross profit, that budgets are maintained, and changes in scope applied as necessary. Additionally, implements a project review process to ensure that resource, deliverables, scope, quality, and budget are maintained appropriately
Manages the achievement of departmental sales, revenue, utilization and gross profit targets
Serves as primary interface between company and sponsors, vendors and other departments in the area of data management
Serves as an authority in the design and implementation of data management strategies
Oversees the planning, execution, and maintenance of major projects, if required
Ensures that all aspects of the Company’s data management processes, procedures, and technology are consistent with current industry practices and meet all pertinent regulatory requirements, both domestic and international
Develops Standard Operating Procedures (SOPs), data management tools, training, department budgets, and staffing requirements
Regularly reviews all relevant projects for financial control and operational productivity
Consults with Business Development activities as required. Reviews and approves the Data Management portion of any proposal and budget which dictates the work will be undertaken in the assigned office
Leads Data Management personnel through audit situations, including closing out audit findings
Maintains current professional knowledge in fields of information management, computer science, quality assurance, regulatory affairs, and applicable areas of medical sciences to serve as a basis for providing “value added” expanded company services to all appropriate clients
Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences. Takes the opportunity to network with colleagues for new and/or repeat business. May represent the Company at professional meetings or seminars

Director, Clinical Data Management Resume Examples & Samples

Selects, develops, and retains high quality employees (particularly managers) setting and achieving objectives that support the overall THV Clinical Affairs goals
Evaluates the CDM resources and solves resourcing issues
Sponsors and leads process improvement projects within Clinical Data management
Works closely with Senior Director, Biometrics and collaborates with other THV Clinical Affairs leadership members to ensure that the CDM SOPs, Work Instructions, and policies are complete and up to date
Creates, develops, maintains and enforce CDM policies to ensure the data collection and data cleaning are efficient and meet the needs of THV registration filings
Ensures that internal and external resources are trained and equipped to achieve high quality results. This includes training of internal resources and selection and management of vendors
Liaises with other Stakeholders within THV Clinical Affairs to assess and continuously improve processes within the department, particularly as related to acquisition of clinical data and delivery of tools that provide information about clinical data status and study conduct metrics
Ensures that data management methods used are consistent with industry best practices and regulatory trends and requirements
Works with Senior Director, Biometrics to manage the budget for THV Clinical Data Management according to expected standards
Bachelor's Degree or equivalent: Computer science, life sciences or related fields (preferred)
Focused on Clinical Programming and Data Management
Has demonstrated expertise with clinical data management, clinical database design, EDC programming, and application validation
Has strong managerial experiences and human skills to lead a team of CDM professionals
Has excellent knowledge of global regulatory requirements related to computerized systems used in clinical investigations, data handling, and patient privacy
Maintains a high level of knowledge regarding current industry and regulatory trends and requirements and ensures THV Clinical Data Management systems and processes are consistent with these

Clinical Data Management Associate Temp Resume Examples & Samples

Associate’s degree in a scientific or health-related field is required
Minimum of 1-3 years of experience in clinical data management
Broad knowledge of data management processes, including EDC experience
Understanding of GCPs, FDA regulations and ICH guidelines is required
Ability to manage multiple projects and timelines simultaneously
Excellent organizational skills and attention to detail are required

Global Study Operations Clinical Data Management Manager Resume Examples & Samples

Proven project management/lead and planning experience
Bachelor’s degree or equivalent in life science, computer science, business administration
Experience in RAVE EDC will be highly regarded
Experience in working in a global outsourced environment

Director, Clinical Data Management Resume Examples & Samples

Serve as Head of Data Management (DM) and oversee all DM activities across multiple clinical development programs. Continue to build and expand the DM department
Collaborate with Biostatistics and Programming to help build the Biometrics function at Avanir
Recruit and train high performing DM staff. Foster career growth within the department and expand the technical expertise of DM staff
Coordinate and drive all DM activities to support corporate goals and objectives and deliver timely, high-quality results
Develop clinical data standards in strong adherence to CDASH and SDTM guidance
Manage clinical data transfers and data outputs across multiple compounds and projects
Manage the budget for the DM department and data-related contracts
Collaborate with cross-functional individuals from Clinical Operations, Clinical Development, Medical Affairs, Safety/PVG, Regulatory, Project Management, and Clinical Supplies in support of project deliverables and regulatory needs
Develop DM SOPs, Work Instructions and/or Guidelines
Create thorough data quality checks and data review strategies to ensure the integrity of the clinical data
Perform thorough reviews of critical CDM documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, edit check specifications, and data management plans
Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock Tables, Figures and Listings (TFL) shells
Participate in reviews of blinded TFL output prior to final database locks
Establish reports to assist with data cleaning, query metrics, and identification of data trends
15+ years clinical data management experience in the pharmaceutical/CRO industry
15+ years of hands-on Electronic Data Capture (EDC) experience
Strong leadership skills within a variety of professional applications that include, but are not limited to: department leadership, project team leadership, and the ability to coordinate activities strategically in support of corporate goals and objectives
Exceptional planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail
Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices
Proficient in the use of the following software programs: MS Word, MS Project, MS Excel, Adobe publishing
Experience with SAS or SQL programming techniques with clinical data management application a plus
Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines
Ability to juggle multiple tasks and priorities
Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with outside vendors, consultants, and team members
Ability to thrive in a fast-paced environment with a sense of urgency and commitment to meet deadlines

Associate Director, Clinical Data Management Resume Examples & Samples

Prepare data management plans
Create, review and update data management SOPs, processes and flow charts
Review and quality control study report tables, graphs, and SAS data listings
Assist in the design of databases and perform validation of edit and range checks for the databases
Assist in the review of the sample case report forms and annotated case report forms
Review and quality control checks of study data
Supervise entry, and assignment of AE MedDRA and WHODrug codes into database in association with drug safety personnel
Assist in the preparation of statistical contributions to study reports and integrated summaries for pharmacokinetic, pharmacodynamic, efficacy and safety analyses
Assist BD activities related to DM

Clinical Data Management Associate Resume Examples & Samples

Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical laboratory data acquisition, quality checking and reporting
May lead in the design and implementation of clinical data management processes with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery
Leads the design of contracts and data transfer agreements with laboratories for sound and through data collection through the regulatory approval process
Reviews study protocols and assists in the planning and implementation of the data management portions of clinical research projects
Interacts with lap staff, site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in timely manner
Utilizes reports to track study progress and ensure timeliness and quality expectations are met
Excellent verbal and written communication skills and interpersonal skills are required
The ability to problem solve and have people/project leadership skills
General knowledge of FDA regulations and clinical data management systems is also required
1 years of experience and a MS degree or PhD

Clinical Data Management Associate Resume Examples & Samples

Works collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians and other Clinical, DSPH, Regulatory and Project Management staff to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
Demonstrates a general understanding of each assigned protocol, critical tasks and milestones
Assists in the implementation of routine clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery
Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process
Assists in implementing routine clinical research projects
Reviews study protocol and assists site coordinators, investigators, and field clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries
Knowledge of FDA regulations, support of needs for NDA and other regulatory submissions, and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems
Demonstrates understanding of project timelines and metrics to ensure databases are delivered to timelines

Clinical Data Management Team Lead Resume Examples & Samples

Manage the DM team according to the Icon way including developing the employees and the team to meet Icon business needs
To ensure excellent quality management system within team
To ensure excellent organizational effectiveness within team
To ensure people development and people engagement within team
Follow up on deliverables ensuring timely, high quality and cost-effective outcome and communicate progress to the manager
Ensure that all employees in the team are provided the needed support and possesses the necessary competencies
Support the team in their communication with stakeholders (e.g. trial management, safety, vendors and management)

Associate Director, Clinical Data Management Resume Examples & Samples

Select vendors and technology to meet the needs of Kite’s clinical development programs
Provide CDM expertise to database set up, CRF design, and data cleaning to efficiently ensure high quality data
Manage vendors, and ensure appropriate resources are available to meet the demands of the clinical development programs and regulatory filings
Manage CDM deliverables in coordination with internal and external cross functional teams
Oversee the development of CDM standards and infrastructure to support global projects
Actively participate in the development and review of documents such as CRFs, data management plans, dataset transfer standards, WHODrug and MedDRA coding standards, manual review plans, line listing review plans, and data validation plans
Proactively make recommendations regarding the development and use of appropriate tools to further support and strengthen the collection and review of data
Ability to collaborate with Statistical Programming, Biostatistics, Drug Safety, CROs and technology providers
Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks

Associate Director, Clinical Data Management Resume Examples & Samples

Partners with functional area representatives to ensure appropriate use of database standards and project-level consistency on database, data collection, review, and retrieval specifications
Project plan development, execution, and change control
Project team development, resource planning, and cost estimating
Risk management
Communications planning, information distribution, performance reporting, and project closure
Provides direction for integrating external teams into the data management processes and ensures that data from disparate sources and database structures align with the clinical data management strategy. Participates in the development of, and ensures adherence to, MSD clinical and regulatory data management standards
Mentors, guides, and provides project leadership for junior staff as assigned
Keeps abreast of project and clinical data management disciplines through interaction with experts both within and outside of the company
May lead continuous improvement special projects, or perform any other data management tasks deemed appropriate by management
At least 6 years’ experience in Clinical Data Management
Full life-cycle experience in clinical data management (data collection system development through database lock and close-out
At least 3 years’ experience working with project management tools and processes
At least 2 years' experience/exposure working in the Oncology Therapeutic area

Director, Clinical Data Management Resume Examples & Samples

Resolve resource and scheduling issues
Work closely with cross-function partners in Clinical and Regulatory Affairs
Create, develop, maintain and enforce CDM policies, procedures and work instructions to assure the efficient and effective collection of clean, reliable clinical data
Bachelor’s degree or higher: computer science, life sciences or a related field
Focused on programming and data management in a clinical or related health-care setting
Demonstrated expertise in clinical data management, clinical database design, EDC applications, application validation and user support
Managerial experience and people skills to lead a diverse team of CDM professionals

Senior Analyst Clinical Data Management Resume Examples & Samples

Define and specify clinically complex data collection requirements (such as eCRFs, CRFs, edit checks and collection of external data) for assigned studies; including defining, performing, and coordinating testing of data collection instruments (e.g. test scripts and checklists) to ensure appropriate data are collected
Other incidental duties
At least 3 years monitoring or management of clinical studies in European Union (medical device trials preferred, also pharmaceutical trials)
Minimum five years experience in clinical research (including a minimum of three years experience in Clinical Data Management (CDM) and/or clinical data entry)
Fluent English (written & spoken), additional European language desired
Experience with electronic data capture, preferred
Excellent written and verbal communication skills, analytical skills, strong organizational skills, self-motivated, flexibility and adaptability

Director, Clinical Data Management Resume Examples & Samples

Supervisory and leadership responsibilities for all data management and back-end activities supporting Alkermes clinical programs from DM strategy, database start-up through database lock and CSR/submission
Manages relationships and establishes partnerships with CROs, vendors, and other external partners including strategic partnerships and preferred provider relationships, and participation in CRO/vendor selection for Data Management services and software
Oversight of data management vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
Oversight of key documents such as data validation specifications and programs, manual data review guidelines, computerized edit check programs, Data Management Plans (DMP), etc…
Work closely with Statistics & Programming to ensure high quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc
Develop, track, analyze, and report on internal data management performance metrics
Contributes to back-end project budget/resource planning, re-forecasting, program milestones, along with CPMs and Clinical Operations management
Bachelor’s in Science and/or Computer Systems/IT background; MBA, advanced degree and/or PMP Certification strongly preferred
Minimum 15 years (5 years management/leadership) experience in a pharmaceutical/biotech setting preferred
Advanced experience in CRO and vendor oversight in fully outsourced or FSP resource models
Advanced knowledge of GCP/ICH standards, 21 CFR Part 11, CDISC requirements
Strong leadership skills and ability to work within cross-functional teams

Clinical Data Management Resume Examples & Samples

Manage day-to-day operations of assigned studies
Responsible for planning, assigning, and reviewing work performed by Data Managers and FSP teams
Manage data management communication and provide conflict resolution for any data management issues that may arise during the study
Create, review, and approve study documentation following GxP and sponsor’s policies, guidelines, and procedures
Manage relationships with external vendors as well as consultants/functional service providers assisting in the study
Collaborate with other LDMs to discuss issues and identify solutions across therapeutic areas
Ensure successful, timely and cost effective development and implementation of high quality deliverables
Ensure adherence to standard operating procedures and working practices for assigned projects
Participate in development, defining, maintenance, and enforcement of standards
Train, monitor, and mentor Data Managers as required for assigned projects
Assigning work, reviewing work, and Planning other’s work
Expertise in time and resource management required
Good organizational skills with great attention to detail and the ability to multitask
Ability to delegate, assign, and monitor workflow
Capable of leading teams and working collaboratively in a team environment

Associate Director, Clinical Data Management Resume Examples & Samples

9 years of experience and a BS degree
7 years of experience and a MS degree
5years of experience and a PhD

Senior Clinical Data Management Associate Resume Examples & Samples

5 years of experience and a BS degree
3 years of experience and a MS degree
2 years of experience and a PhD

Associate Director Clinical Data Management Resume Examples & Samples

Represent Clinical Data Management at cross-functional forums, meetings and provide timely feedback to partners
Lead and support clinical & non-clinical special projects
Support the establishment of training programs (technical and professional skills) for Clinical Data Management staff and ensure staff training is conducted and properly documented
If required, deputize for the responsibilities of the Operational/Functional Manager
Ensures that there is adequate and appropriate resources to manage the study for Clini-cal Data Management activities
Provides all necessary support to address any issues requiring management input
Represents the group in any forums including leadership team meeting to address issues. Ensure process improvements suggestions are evaluated and support team to bring suggestion to management for consideration
Provides management oversight for all the activities for Clinical Data Management during study startup
Authorizes the GoLive based on a review of completion of all activities for pivotal trials
Provides management oversight for all the activities for Clinical Data Management during data finalization
Ensure data finalization activities are appropriately managed for pivotal trials
Provides management oversight for all the activities for Clinical Data Management for optimization of data quality management and accurate reporting of statuses
Liaise with Operations and Central Services team to address any issues in the reporting of metrics
Provides management oversight for all the activities for Clinical Data Management for the management of third party data
Liaise with Operations and Central Services and outsourcing management teams to ad-dress any issues of 3rd party vendor management and CRO partners
Ensures that the group including managers has completed all their training requirements
Ensures that the associates are fully applying the GCP Principles, DM Standards, SOPs/WPs and process guidelines
Participates in Health Authority inspections as required
Ensures that each associate has an up to date training and development plan in place
Ensures adequate resources are in place for the management of programs
Reports to Director if there are any additional unanticipated demand for resources for activities such as post-submission activities
Ideally 10 or more years’ experience in drug development with at least 8 years in Clinical Data Management
Strong technical and problem solving skills, and ability to evaluate computer systems for Data Management
Excellent understanding of clinical trials methodology, GCP and medical terminology

Senior Mgr / AD, Clinical Data Management Resume Examples & Samples

Manage CDAs efficiently across studies by setting goals and providing oversight, guidance, mentoring, feedback and performance reviews.Perform hiring and training activities as needed
Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product.Assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
Independently develop and manage the development of DM deliverables including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications and Data Review Plans. Ability to run SAS programs, review SAS logs, and generate output.Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level.Mentor less proficient SAS users as appropriate
Independently lead data cleaning activities such as but not limited to Study Team data reviews, SAE reconciliation and non-CRF data reconciliation
Independently manage the database lock process in an efficient and timely manner
DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines.Assist DM Management in coordinating and/or supervising data management activities across studies
Ability to research, evaluate and lead departmental initiatives and new technologies/innovations to improve CDM processes; represent CDM through working groups (internal and external) and initiatives where thorough knowledge of CDM practices/processes are required
Lead the Data Standards Committee (DSC) through role as DSC Chair. Support implementation of data standards
Responsible for oversight of Centralized Monitoring and support of expansion of centralized monitoring efforts within Data Management
Serve as liaison between Data Management and Clinical Information Systems to support infrastructure development and improvements
Serve as liaison between Data Management and Biometrics
BA/BS in relevant field and 10+ years experience and 5+ years management experience
Requires effective organizational and communication skills
Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
Detail oriented; performs quality and accurate work
Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
SAS programming experience; ability to program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings.Mentor less proficient SAS users as appropriate
Previous vendor/CRO management required
Previous management experience is required
Thorough knowledge of the database development process
Strong experience and knowledge in the application of data standards
Excellent supervisory, problem solving, negotiation and organizational skills

Senior Mgr Clinical Data Management Resume Examples & Samples

Management of clinical data vendors to achieve the productivity, quality, and timelines requirements of projects
Maintaining optimal department processes and implementing excellent project-specific strategies
Technical data management leadership or oversight on global, large and/or multiple projects
Responsible for the development of project Data Management Plan(s); data management systems set-up, data accession, data entry and data review specifications and processes
Technical oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project(s) timelines and budgets
Develop and maintain a close liaison with project client contacts, core team members and Project Managers
Minimum seven (7) years relevant work experience in data management with four (4) years technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas
Demonstrated skill for technical and supervisory leadership of 8-15 staff within one or more locations in a region
Excellent oral and written communicat ion and presentation skills
In depth knowledge of clinical trial process and data management, clinical operations,
In depth knowledge of tracking of staff productivity and quality metrics
Demonstrated skill for mentoring and developing staff on technical and core competencies
Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical biotechnological companies
Operational experience in other disciplines such as clinical, biometrics, medical writing, pharmacovigilance, safety, quality assurance, regulatory, etc
Demonstrated ability to lead by example teams on strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions
Strong leadership and interpersonal skills

Senior Manager / AD Clinical Data Management Resume Examples & Samples

Oversees the Clinical Data Management Department, with direct supervisory responsibilities for all in-house and external data management personnel (e.g., contractors and functional service providers)
Supervises CRO data management activities, including evaluating and selecting CRO vendors and tracking quality of CRO data management performance
Oversees third party data integration, from selection of vendor to review of data to final deliverable
Collaborates and coordinates with study team members to assist in the design, review and creation of high-quality clinical protocols
Develops systems for organizing data to analyze, identify and report data and trends
Designs on-line case report forms for EDC data management system
Creates Data Validation Specifications
Creates eCRF Completion Instructions
Executes study specific procedures compliant with Regulatory and internal requirements
Represents Clinical Data Management in project team meetings
Reviews the Tables, Listings and Figures
Supports the generation of clinical study reports
Establishes timelines for assigned projects
Works extensively with project leaders, clinical team members and CROs
Interacts with functional groups that are contributing to the clinical data management plan
Liaise with clinical, safety and regulatory organizations for coordination of global activities
Trains appropriate team members on department SOP’s and identifies gaps in current processes and develops solutions
Develops and maintains department standards (e.g., SOPs)
Member of Biostatistics and Data Management

Clinical Data Management Intern Resume Examples & Samples

Understand Clinical Trial Process
Clinical Trial lifecycle – Protocol to Database delivery
Clinical Database Development / Specifications
Understanding of project timelines
Clinical Data Management tools and processes
Develop & QC Reports (either standard or study-specific)
Have the conceptual understanding to be able to question why processes are as they are and put forward thoughts of improvement whilst considering impact on current activities
Understand the need for focus & detailed working, but also seeing the process as a whole
Recognise the importance of having a well balanced team and how each individual contributes differently
Identify which area / department / skill-set the individual would like to develop for future employment
An interest in the Pharmaceutical industry, clinical trial and drug development process
Ideally looking for someone with SharePoint knowledge
A good technical ability desirable
Strong grasp of basic Microsoft tools (word/excel/outlook etc) is required
Critical thinking and attention to detail

Senior Specialist, Clinical Data Management Resume Examples & Samples

Oversee the successful execution of the Patient Reported Outcomes strategy for one or more programs, providing end-to-end technical project management support to clinical project teams and ensuring that all aspects of the Patient Reported Outcomes project plan (from protocol initiation through system closeout) are executed on time, and with highest standards of quality
Ensure that vendors are planning and managing timelines and employing risk management techniques across all programs
Have operational visibility across all studies in a particular therapy area of focus
Monitor execution of the system development process from kickoff to system go-live, ongoing system change control, system closeout and database lock activities; perform cost / benefit analysis for projects, as appropriate
Develop vendor-specific strategies for Patient Reported Outcome projects and provide input to cross-vendor project strategies; and manage vendor performance and relationship(s)
Define and implement process with vendor representatives, monitoring and analyzing vendor and Merck performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues
Develop and maintain relevant documentation, including applicable Standard Operating Procedure, job aids, and guidance documents
Define process in collaboration with stakeholders and manage implementation plans
Function in the Patient Reported Outcome SME role independently and work to resolve conflicts that are complex, cross departmental, or external to Merck
Independently prioritize work activities to align with team objectives and current activities
Provide training and education for stakeholders; and serve as project or program manager of all Patient Reported Outcome activities for projects assigned

Director, Clinical Data Management Resume Examples & Samples

Lead the CDM function at Frontage Clinical Services to maintain customer satisfaction and promote employee engagement
Supervise, coach, and mentor the staff of CDM
Willing to maintain regular office hours in either our Secaucus or Somerset, NJ offices
Stay up-to-date on topics in data management in order to inform the organization, ensure regulatory compliance, and to adopt newly available technologies in a timely fashion
Create, review, and update CDM processes and Standard Operating Procedures
Develop metrics for assessment of CDM performance and regularly assess the performance for those metrics
Review and evaluate data management plans for study implementation
Ensure that study report tables, graphs, and data listings are produced with the highest level of quality
Direct the design of databases and validation of edit and range checks for those databases
Manage development and review of case report forms and annotated case report forms
Supervise entry and assignment of MedDRA and WHODrug codes into database through cooperation with drug safety personnel
Cooperate on the delivery of datasets for statistical contributions to study reports and integrated summaries for pharmacokinetic, efficacy, and safety analyses
Interact with other project team members and clients
Support Business Development activities related to CDM
Minimum of a Bachelor’s degree in a biomedical or computer science discipline, or equivalent training is required
At least 10 years of experience in data management in a clinical research environment; early phase clinical experience preferred
Clinical database management skills necessary
At least 3 years of managing direct reports required
Experienced in working with EDC systems and vendors
Proficient in computer skills (word processing, spreadsheets, graphing software)
Expert knowledge of medical and data management terminology

Director, Clinical Data Management Resume Examples & Samples

Bachelor’s degree in Health Science, Pharmacy or Life Sciences from accredited college or university. . Advanced degree preferred
Minimum of 10 years of Data Management and Clinical Trial experience in the Biotech/Pharma/CRO industry
Minimum 10 years of line management and project team leadership experience, as well as process management and innovation
Prior experience with clinical trials leading to NDA submissions. Prior engagement with NDA eSubmission
Demonstrated strong technical and problem solving skills
Excellent written and verbal English communications skills, including presentation skills
Excellent MSOffice skills including Word, Excel, PowerPoint, Outlook
Demonstrated team management skills
Proven ability to manage multiple projects, set priorities and meet deadlines
Ability to work well on a team and independently

Head, Clinical Data Management Resume Examples & Samples

Develop data collection standards for Moderna
Develop best practices for data handling
Consult with CROs to solve operational data issues and maintain vendor oversight
Work effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics and data review tools
Manage clinical trial data through oversight of cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements
Ensure timing and integrity of data transfers from all vendors
Review data analysis listings and report on performance and quality
Review clinical data within studies and across for trend analysis
Support the strategy for data cleaning to ensure timely deliverables
Support the data collection through efficient eCRF and database design
At least five years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas
At least 10 years of clinical data management experience in industry, with experience across indications and EDC platforms
Multi-faceted background devising plans for operational challenges such as site EDC training, preparing cohorts for data review in dose escalation, vendor oversight, protocol deviation management, data cleaning, etc
Cross Collaboration proficiency with other functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
Thorough command of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
Outstanding verbal and written communication skills, in addition to excellent organizational skills
Early and late development experience
Vendor management and oversight experience
Strong technical skills across data platforms
Experience with Spotfire or other data visualization software
Bachelor’s Degree in a science-based subject

Associate Director, Clinical Data Management Resume Examples & Samples

Responsible for ensuring that Data Management SOPs, Work Instructions and Templates represent current industry practices, Regulatory guidelines and standards
Oversight of build, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
Bachelor’s in Science and/or Computer Systems/IT background; MBA, advanced degree and/or PMP Certification required
Minimum 10 years experience in a pharmaceutical/biotech setting preferred

Intern, Clinical Data Management Resume Examples & Samples

Has basic understanding of relational database elements: tables, variables, variable properties
Can understand and execute test script instructions, can understand simple edit check conditions (e.g. interval and range checks). Can evaluate if a tested item has failed based on test script of Testing instructions. Can effectively communicate test failures to database developers
Can understand regulatory requirements for Clinical Data Management documentation

Data Team Lead, Clinical Data Management Resume Examples & Samples

Project management of all data management through to completion
Providing this expertise to customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and technical expertise
Managing and organizing data so that it is accessible and sufficiently well summarized for customer and regulatory bodies such as the FDA
Acting as a point of contact for various stakeholders including customers and the Clinical Data Management team, as well as working closely with the data programmers
Understanding the components of a study start up through to study close out, and developing key documentation
Creating and working with a supportive team environment, and sourcing candidates who will contribute to the expected high standards

Director, Clinical Data Management Resume Examples & Samples

Leads and oversees Clinical Data Management function and EDC programming (through external vendors)
Provides leadership within Clinical Data Management by collaborating with internal and external stakeholders to optimize data management technology, processes and standards and to enable successful execution of corporate objectives
Identifies ways to continuously improve all aspects of data management and implements solutions; strengthens and enhances the data management service, operations, and execution
Coaches, develops and provides continuous feedback to a team of direct reports / Provide guidance and direction to ensure departmental and client/project goals are met
Responsible for hiring, training, development and management of staff; ensures effective resource allocation
Serves as the lead liaison to internal and external clients
Develops and tracks metrics on productivity and quality and creates strategies and best practices to increase efficiency and quality
Responsible for overseeing all data management activities leading up to and including interim and/or final database locks inclusive of interacting with the appropriate cross-functional staff: Clinical Operations, Biostatistics and programming to meet Company’s objectives
Develops departmental policy, standard operating procedures, and work instructions
Ensures that standards are applied across studies (EDC Builds, CRFs, CRF Completion Manuals, Edit Checks, etc.)
Oversee the development and validation EDC study builds and the associated data listings, reports, data transfers and detailed timelines
Monitors data management workflow and tracks project metrics
Defines CRF standards, oversees individual study CRF design and production
Develops department goals and objectives and implements plans to meet the them
Manages department budget development to forecast
Identifies need for external support; negotiates agreements to secure contract staff and/or vendors
Oversees selection and management of study vendors
Leads strategic planning and execution of the department’s objectives including timeline and budget projections, risk mitigation strategies, and data management governance
Effectively interfaces with Senior Management and other functional areas to assure coordinated expectations and deliverables from Clinical Data Management
Ensures that the clinical programs are executed in compliance with ICH Guidelines, GCP and CRF Part 11, and any other local requirements
Bachelor’s Degree; advanced degree in related field preferred
Minimum of fifteen (15) years of relevant data management experience, including five (5) years in a supervisory role, either as a functional/line manager or co-accountable for performance management within a team matrix, or combination of equivalent experience
Comprehensive knowledge of GCP, ICH, CFR Part 11 and computer systems validation; sufficient knowledge of Competent Authority regulations in regions outside the US
Proficiency with web-based EDC systems
Experience with medical coding preferred
Experience with SAS programing preferred
Demonstrated knowledge in several relevant therapeutic areas
Advanced computer skills in Word, Excel, PowerPoint, and MS Project

Clinical Data Management Associate Resume Examples & Samples

Assist in the development of study Data Management Plan, including Edit Check Specifications, eCRF completion guidelines, and /or required data management documentations and raise queries to resolve erroneous, missing, incomplete or implausible data
Perform data review and query management to ensure that quality standards are archived
Generate, resolve and track queries to address problematic data identified during aggregate data review activates and apply proper modification/correction to the database as required
Create test scripts from Edit Check Specifications to test edit checks and to test database screen functionality
Assist in reconciling AE/SAE data in Clinical Data Management Database with Medical Monitor
Assist the Data Management team with all data management activates from study start-up to database lock
Oversee and supports data acquisition from external sources
Manage vendor performance and deliverables according to the Scope of Work to ensure quality and timelines if applicable
Provide input the development of departmental standards and operating procedures
File Data Management documentation and execute Data Management related administrative tasks as requested, including maintenance of TMF as required
Perform any other duties as assigned
Education: Bachelor Degree in Science or Business related field and/or equivalent work experience
Experience: A Minimum of 2 years of Data Management experience to include essential duties above within a pharmaceutical, medical device, biotech or CRO required
The preferred candidate must have strong writing, verbal communication skills and organizational skills

Director, Clinical Data Management Resume Examples & Samples

Lead the CDM function at Frontage Clinical Services to maintain customer satisfaction and promote employee engagement Supervise, coach, and mentor the staff of CDM
Create, review, and update CDM processes and Standard Operating Procedures Develop metrics for assessment of CDM performance and regularly assess the performance for those metrics
Ensure that study report tables, graphs, and data listings are produced with the highest level of quality Direct the design of databases and validation of edit and range checks for those databases Manage development and review of case report forms and annotated case report forms
Cooperate on the delivery of datasets for statistical contributions to study reports and integrated summaries for pharmacokinetic, efficacy, and safety analyses Interact with other project team members and clients
Support Business Development activities related to CD
At least 10 years of experience in data management in a clinical research environment; early phase clinical experience preferred Clinical database management skills necessary
At least 3 years of managing direct reports required Experienced in working with EDC systems and vendors Proficient in computer skills (word processing, spreadsheets, graphing software)
Excellent verbal and written communication skills Expert knowledge of medical and data management terminology

Specialist, Clinical Data Management Resume Examples & Samples

Serves as project manager of all IRT & COA systems activities for protocols assigned. Uses interpersonal, negotiating, and project management skills to perform the following tasks
Provides support for successful integration of Merck and vendor systems
Provides support for problem resolution between IRT & COA systems vendors and Merck Clinical Trial Team
May assist in development of, reference and/or training material
May support a continuous improvement special project or any other project or perform any other IRT & COA systems related task deemed appropriate by management
4 years’ experience in Clinical Data Management with at least 2 years’ of IRT Systems and/or COA working experience
Demonstrate knowledge of IRT & COA systems development processes
Knowledge of the clinical development process, preferably through submission; thorough knowledge of clinical data management
Solid experiences in study start up activities for EDC Inform/ IRT Systems/ COA (paper & e)
Demonstrated project management skills; strong organizational, communication, and problem-solving skills
Experience working with external vendors

Associate Director, Clinical Data Management Resume Examples & Samples

Participates in recruiting efforts
Directs the activities of CDM team members to complete project deliverables on schedule and according to quality standards, and requirements from study start-up through archival
Contributes to performance reviews of project team members
Ensures projects are conducted in compliance with operating procedures and good clinical practices
Review and provide input for reports and clinical documents such as clinical protocols, informed consent, Investigator Brochure, yearly updates to the regulatory authorities and status updates
Participate in cross-functional initiative teams
Represents data management on project teams and manages scheduling and time constraints across multiple projects/resources
Recommends alternative work processes to improve the quality or speed of internal customer deliverables and responds to customer/team questions on CDM process, timelines and data quality
Communicates and escalates project level issues including processes, timelines, resourcing, performance, etc. and establish appropriate course of action with Senior Management
Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements
Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines
Assist in preparation and support of clinical documentation for IND and NDA submissions as appropriate
Support regulatory submission activities for assigned projects
Minimum of 7 -10 years in pharma or CRO industry, with minimum of 5 years in hands on leadership functional/line role
At least 5 years of recent Oncology trials data management experience is required
Proficiency in Microsoft Office tools
Experience using clinical data management systems and/or EDC products (e.g. RAVE, Inform, Oracle Clinical/RDC, etc.)
Track record of completed deliverables on time and adjust priorities in a fast paced environment
Has worked independently as well as collaboratively in a team environment
Strong experience in CRO and vendor management for global clinical trials

Associate Director, Clinical Data Management Resume Examples & Samples

Bachelor’s degree or above in a biomedical or computer science discipline or equivalent experience is required
Must be proficient in computer skills (word processing, spreadsheets, scientific graphing software)
Knowledge of medical and data management terminology essential
At least 5 years of experience in data management in a clinical research environment
Database management skills necessary
Assist in the preparation of statistical contributions to study reports and integrated summaries for pharmacokinetic, pharmacodynamic, efficacy and safety analyses Interact with other project team members and clients Assist BD activities related to DM

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