Clinical Data Associate Resume Samples

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C Reichel

Camron

Reichel

25718 Hattie Well

San Francisco

+1 (555) 357 4484

25718 Hattie Well

San Francisco

Phone

p +1 (555) 357 4484

Experience Experience

New York, NY

Clinical Data Associate

New York, NY

Corwin and Sons

New York, NY

Clinical Data Associate

Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, the drug development process
Assists the Clinical Data Manager(s) [CDM] in any assigned clinical data management tasks across multiple projects
Support CDM process and application improvements; participate in working groups to develop and implement new processes and applications
Develop test plans and perform testing to validate databases built by other members of the data management team
Perform other duties as assigned by management
Create User Acceptance Test Scripts from Edit Check Specifications and create dummy data to test edit checks and to test database screen functionality
Assisting in establishing and enforcing departmental standards

New York, NY

Clinical Data Associate / Coordinator

New York, NY

Koelpin Group

New York, NY

Clinical Data Associate / Coordinator

Review and clean data errors for consistency and accuracy according study guidelines and conventions
Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base
Good knowledge of processes and procedures in clinical data management
May 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
Participate in project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders
Good knowledge of protocols, DMPs, and SAPs
Develops solutions to a variety of problems of basic scope and complexity

present

Detroit, MI

Senior Clinical Data Associate

Detroit, MI

Renner-Auer

present

Detroit, MI

Senior Clinical Data Associate

present

Independently develop DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans
Independently lead data cleaning activites such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation
Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications
Thorough knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, medical coding, the drug development process
Detail oriented; performs quality and accurate work
Independently manage the database lock process in an efficient and timely manner
Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession

Education Education

Bachelor’s Degree in Confidentiality With Clinical Data

Howard University

Bachelor’s Degree in Confidentiality With Clinical Data

Skills Skills

7,Ability to demonstrate a constructive probelm solving attitude while dealing with time demands, incomplete information or unexpected events
6,Excellent oral and written communication skills
5,Potential ability to lead by example data management staff
5,Good oral and written communicaiton skills
3,Demonstrated ability to work in a team environment and collaborate with peers
Ability to work independently in a group setting; ability to adjust to changing priorities
Excellent attention to detail
Strong interpersonal and communication skills, both verbal and written
Strong documentation and organizational skills
Ability to project and maintain a professional and positive attitude

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15 Clinical Data Associate resume templates

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Clinical Data Associate Resume Examples & Samples

Bachelor’s degree in related science/technical discipline and/or 5+ years of data management experience in the pharmaceutical or biotechnology industry
2+ years of experience developing database and validation specifications
2+ years of experience with Electronic Data Capture
1+ years of experience with reporting tools (e.g., BOXI, SAS and Business Objects)
1+ years of experience in writing SOPs, work instructions, data management plans and guidelines

Clinical Data Associate Resume Examples & Samples

Support development of DM study documentation, including: Data Management Plans, annotated CRFs and specifications, CRF Completion Guidelines, Data Transfer Plans, etc
Support User Acceptance Testing of Database
Support SAE Reconciliation
Support DM SAS programming activities
Provide DM infrastructure support as needed (i.e. policy development, Lab Normal database)

Clinical Data Associate Resume Examples & Samples

4 - 6 Years of experience in developing database and validation
2 - 4 Years of experience with Reporting Tools (e.g., BOXI, SAS, Business Objects)
2 -4 Years of experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines

Clinical Data Associate Resume Examples & Samples

Adhering to department processes and standards
Assisting in establishing and enforcing departmental standards
Participating in the review and updating of company SOPs related to department
Bachelor’s degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
Additional skill set
Ability to work independently in a group setting; ability to adjust to changing priorities
3+ years’ experience in comparable position within the pharmaceutical, biotech or CRO industry
Working knowledge of relational database organization and validation
Proven ability in problem solving

Clinical Data Associate Resume Examples & Samples

Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s)
Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s)
Enters test data for data entry screens
Enters test data for edit checks
Performs review of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, drafts queries or proposes self-evident corrections or other global rulings permitted in cases where queries are not required, per the Clinical Data Validation Plan for the assigned projects
Issues queries to sites
For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly
For paper studies, performs internal audit and quality control checks on listing output from database against Case Report Forms (CRFs) and Data Clarification Forms (DCFs). For EDC studies, performs DM Review (Rave) and/or other internal audit and quality control checks as required per applicable EDC systems
For paper studies, ensures all Case Report Forms (CRFs) and Data Clarification Forms (DCFs) received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects
Participates in internal meetings
Participates in customer and third party meetings, distributing relevant information in advance; ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution
Participates in internal/external audits
Maintains proficiency in Data Management systems and processes through regular training and/or attendance at professional meetings/conferences

Clinical Data Associate Resume Examples & Samples

Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the CRF database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Clinical Data Validation Plan for the assigned projects. Resolves queries correctly answered and re-queries where appropriate. Provides assistance and guidance to other Clinical Data Associates with the above tasks
Reviews queries, self evident corrections and the application of global rulings, proposed by less experienced Data Management staff
Reviews queries raised by staff responsible for the coding of CRF terms for adverse events, medical history, and medications against medical coding dictionaries
Ensures that data from external databases/datasets such as laboratory databases, or electronic diary datasets are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party
Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries
Trains and mentors data management staff providing timely feedback to trainee and management as appropriate
May design, or review designs, for CRF pages and e-CRF entry screens and associated CRF/eCRF visit structure, indexing and version control, coordinating with team members responsible for the associated database design
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

Clinical Data Associate / Coordinator Resume Examples & Samples

Review and clean data errors for consistency and accuracy according study guidelines and conventions
Execute routine metrics to identify trends in data and remediation, utilizing tools (e.g., systems, reports) to assess need for training
Assist in defining and specifying clinically data collection requirements (such as eCRFs, CRFs, edit checks and collection of external data) for assigned studies; may perform user acceptance testing to ensure appropriate data are collected
Participate in project management activities for a cohort or project to bring clinical studies on-line, including conducting project team meetings, establishing and maintaining project timelines, and communications to stakeholders
Maintain and provide feedback on Data Management deliverables including data management plans (DMPs), training materials and user aids in compliance with regulations
Perform Site/User Administration to allow access to the database, ensuring all users are qualified to access data base
May 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
Good knowledge and understanding of policies, procedures and guidelines relevant to clinical research
Good knowledge of processes and procedures in clinical data management
Good knowledge of protocols, DMPs, and SAPs
Develops solutions to a variety of problems of basic scope and complexity
Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
Bachelor's Degree or equivalent in related field 1 year + of previous related experience in clinical research including clinical data management and/or clinical data entry Required Or
Associate's Degree or equivalent in related field 3 years + of previous related experience Required
Experience configuring systems; Experience working with EDC (Electronic Data Capture) systems preferred
Good computer skills in Microsoft Office Suite
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills

Clinical Data Associate Resume Examples & Samples

The objective of a Clinical Data Associate II is to perform advanced aspects of the data cleaning process with a high level of accuracy and in accordance with GCPs and SOPs/WPDs, in order to assess the safety and efficacy of investigational products and/or medical devices
Clinical Data Associate IIs are expected to perform the tasks of a Clinical Data Associate I with increased efficiency, while maintaining a high level of accuracy, and to work more independently
In addition they will be expected to perform data management activities such as Serious Adverse Event and Third Party Vendor reconciliations as well as Data Listing reviews
2-3 years of experience in Clinical Data Management

Clinical Data Associate Resume Examples & Samples

Proven ability in achieving applicable technical competencies per the CDM competency grid
Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations
Must be able to set and meet timelines or be able to negotiate schedule changes in response to project demands
Knowledge of medical/clinical terminology

Clinical Data Associate Resume Examples & Samples

Perform all data management tasks as appropriate to include, but not to be limited to: data review and query management to ensure that quality standards (both internal and client) are achieved
Perform reconciliation of the clinical database against safety data, laboratory data and other third party data as appropriate
Review clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete or implausible data
Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database as required
Run ancillary programs (diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
Interact with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required
Create or review data listings for dose escalation and safety assessments as needed
Assist with creation/reviewing Edit Check Specifications
Create User Acceptance Test Scripts from Edit Check Specifications and create dummy data to test edit checks and to test database screen functionality
Assist in creation of Study Test Plan and Study Test Report documentation
Perform Database Decommissioning and create supportive documentation
Assist in preparing Access Rights forms for EDC database
Support team members by creating forms/memos as required
Filing of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required
Running study status reports
Performs any other duties as assigned
Basic knowledge of computer programs (e.g. word processing)
Strong attention to detail and high degree of accuracy
Ability to follow precise directions
High degree of professionalism and customer service
Fluent in English, both written and verbal

Clinical Data Associate Resume Examples & Samples

Working knowledge of the database development process
With minimal oversight, lead data cleaning activities such as but not limited to Study Team data reviews, SAE reconciliation and non-CRF data reconciliation
Manage work performed by the vendors/CROs as appropriate to ensure quality of product
Oversee user access and account reconciliation of file sharing sites for vendor data transfers
Support processes and infrastructure for managing external data, including: creating templates, specifications, flow charts and guidance documentation
Support and configure applications and software relating to management of third-party data
With minimal oversight, manage the database lock process in an efficient and timely manner
DM Project Management: Understand critical tasks and milestones; ensure data management deliverables are met per study timelines. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables
Support CDM process and application improvements; participate in working groups to develop and implement new processes and applications
Run SAS programs and troubleshoot as needed
BA/BS in relevant field and 3-5 years’ experience; years of experience may substitute for education
Laboratory experience or clinical lab data expertise; understanding of biomarker and flow cytometry testing processes and data reportables (oncology-specific preferred)
Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession. Proficient in MS Excel
Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development, UAT, the drug development process
Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills
Interpersonal skills: Encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
Project Management skills: knowledge of project lifecycle, experience in managing timelines, evaluating risks, documenting decisions, etc
Flexible, easily adapts to change, and is energized by challenges and problem solving
Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate
Strong critical thinking skills, perceives the purpose behind tasks and responsibilities, considers actions in the context of all project stakeholders and end users
Effective time management skills and is able to prioritize successfully
Understands study blinding and recognizes unblinding risks

Clinical Data Associate Resume Examples & Samples

DM Project Management: Understand critical tasks and milestones; ensure data management deliverables are met per study timelines. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables
BA/BS in relevant field and 3-5 years experience; years of experience may substitute for education
Interpersonal skills:Encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively
Understands study blinding and recognizes un-blinding risks

Clinical Data Associate Resume Examples & Samples

Generates and enters test data for user acceptance testing
Performs role-based User Acceptance Testing (UAT)
Creates and enters test data for Standard Data Tabulation Model (SDTM) test data
Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs
Interprets and enters lab normal ranges
Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets
Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the DVS for the assigned projects. Resolves answered queries correctly and re-queries where appropriate

Clinical Data Associate Resume Examples & Samples

Assists the Clinical Data Manager(s) [CDM] in any assigned clinical data management tasks across multiple projects
With minimal oversight, develops and maintains Data Management documentation including, but not limited to, Data Management Plans, Case Report Forms, CRF Completion Guidelines, Edit Check Specifications, Manual Review Plans and database specification documents
Creates test data and test scripts, performs database testing and documents testing results
Leads data review activities including, but not limited to, review of discrepancy output and validation listings, issuing and tracking queries, reconciling data from external databases and non-CRF data sources
Performs internal audits and quality control of data in clinical database as well as database system security and usage
Reconciles project files and other documents generated in data management for accuracy and completeness
Prepares staff and site training materials, reports, trends and summaries or listings of clinical data
Serves as a resource for study monitors as relates to data issues and resolutions
Prior experience working with electronic data capture systems; Oracle Inform or Medidata Rave, preferred
SAS programming a plus

Clinical Data Associate Resume Examples & Samples

Bachelors/ Master’s degree in life Sciences
Excellent English – both written and verbal
Ability to work productively with moderate supervision
Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary data

Clinical Data Associate Resume Examples & Samples

Associate’s degree/Technical diploma or higher from an accredited institution
Experience in clinical data management
Experience with Clindex
Experience in data entry
Experience in basic computer programming (e.g., SAS, SQL)
Excellent time management/project management skills

Clinical Data Associate Resume Examples & Samples

Acts as the primary contact to the study team and program team members for data science and data solution application
Bachelor’s degree in informatics or related field
Experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
Demonstrated ability to articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
Demonstrated ability to decide the technology platform (system/database) for data acquisition and aggregation
Clinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
Strong therapeutic/scientific knowledge
3 years experience in clinical data management and/or 5 years experience in drug

Clinical Data Associate Resume Examples & Samples

Deliverable Ownership and Vendor Management (50%)
Vendors to deliver
Ensure that data management deliverables are delivered to scope, cost, and time objectives
Execute project monitoring and quality oversight of sourcing providers for end-to-end data management activities – from study set up through trial execution through dataset delivery
Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources
Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis
Approve key deliverables (i.e. Data Quality Delivery Plan, Datalock Plan, Project Plan, database, and observed datasets)
Define and approve data quality and submission deliverables
Bachelor’s degree Medical field, Informatics, Data Management, Life Sciences, or Related field

Senior Clinical Data Associate Resume Examples & Samples

Comprehensive knowledge of data management practices from protocol design to database lock. Proficiency with Medidata Rave; basic knowledge of SQL
Experience working under Good Clinical Practices, Good Clinical Data Management Practices, CDISC/CDASH, and other FDA guidelines is required
Proficiency with medical terminology and experience coding clinical data using WHO Drug and MedDRA coding dictionaries
Demonstrated solid oral and written communication skills and analytical/problem-solving skills are essential as is the ability to clearly communicate basic data management concepts to those outside data management
Must be able to effectively manage multiple projects and timelines
Must be able to travel up to 5% per year
Requires the ability to sit or stand while working on a computer for a long period of time

Clinical Data Associate Resume Examples & Samples

Provides single point of accountability and deliverable ownership for all aspects of clinical data management for analysis
Applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, biostatistical, and business demands of the team
Bachelor’s degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
3 years Data Management experience or 5 years experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.)
Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business
Experience with the following

Clinical Data Associate Resume Examples & Samples

Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports
Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required. Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package
Reads and understands project protocol and Data Validation Manual
Contributes to the improvement of data management processes on a global level
Produces project-specific status reports for CDM management and for clients on a regular basis
Performs other duties as require
Bachelor’s degree ORcertification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RPh, RT)
Minimum of 18-24 months experience in data management
In some cases, a demonstration of applicable technical and behavioral competencies, and a combination of 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 ability in achieving applicable technical competencies per the CDM competency
Ability to work productively with minimal supervision
Ability to maintain a high degree of confidentiality with clinical data and client’s proprietary

Clinical Data Associate Resume Examples & Samples

Good written and verbal communication skills and a strong command of English language and grammar
Good analytical /problem-solving skills
Ability to work productively with direct supervision
Understands project protocol and Data Validation Manual

Clinical Data Associate Resume Examples & Samples

4-6 years of experience in developing database and validation requirements/specifications
6-8 years of experience with Electronic Data Capture (EDC)
2-4 years of experience with Reporting Tools (e.g., BOXI, SAS, Business Objects)
2-4 years of experience in writing SOPs, Work Instructions, Data Management Plans and Guidelines

Clinical Data Associate 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)
1+ year experience in a professional environment, preferably with clinical or medical data or in a software development environment
Ability to attain, maintain and apply a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures

Clinical Data Associate Resume Examples & Samples

Minimum of 2-3 years' experience in data management
Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs
Knowledge of medical/clinical trial terminology

Clinical Data Associate Resume Examples & Samples

2) Project management experience of clinical trials
3) Understanding of clinical data management processes
4) Communication with cross-functional study team members
This role will immediately assume biomarker data management responsibilities for representing biomarker data management at the biomarker Sub Team (BST) meetings
The candidate will also be responsible for providing oversight to studies that fall within the BSTs
The selected candidate will manage biomarker data in various stages, from planning, to set-up, conduct, closeout, and archiving, in high volume, while maintaining a high level of data quality by leveraging and adhering to standard data structures and corresponding standard edit checks and review listings
The selected candidate may also manage and lead in the design and implementation of biomarker data management processes with vendors, ensuring completeness, correctness, and consistency according to the standards
This role has a high degree of collaboration with the Biomarker cross-functional team members, study team members and other biomarker Clinical Data Associates
The ideal candidate should possess a BS degree or higher in a Biomedical Science or equivalent and minimum 3 years of relevant clinical data management experience and preferably along with biomarker or laboratory background and experience in a CRO or bio/pharmaceutical setting
Works collaboratively with Biomarker Clinical Operations team members, Biomarker Scientists, Biomarker Statistical Programming group, Biomarker Biostatistics group, Biomarker Clinical Programming group, Biobanking and Sample Management group, and lead study clinical data associate and cross-functional study team members to meet project deliverables and timelines for biomarker data acquisition, quality checking and reporting
Ensure completeness, correctness and consistency of routine clinical data and data structure
Responsibilities include: assisting in the developing the data transfer specifications, the data mapping specifications, the data quality review plan and the data validation specifications, vendor management, data review and data reconciliation
Assists in implementing routine clinical research projects and standards. Identifies, tracks, and resolves routine queries
Utilizes routine reports to track study progress and ensures timeliness and quality expectations are met
3 years of experience and a BS degree

Senior Clinical Data Associate Resume Examples & Samples

Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product.May assist in the selection of vendors/CROs (e.g. review RFPs, attend site audits)
Independently develop DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, 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 activites such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation
DM Project Management: Understands critical tasks and milestones; ensures data management deliverables are met per study timelines. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables.Provide solutions for data management issues that arise during study conduct
Perform medical coding utilizing MedDRA and WHO-DRUG, as appropriate
Evaluate CDM processes and applications for improvements; participate in working groups to develop and implement new processes and applications
Coordinate and delegate work performed by junior CDAs, as needed; assist in mentoring junior CDAs and/or contractors
Utilizes experience and leadership skills to provide guidance to other team members
BA/BS in relevant field and 5+ years experience.Years of experience may substitute for education
Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession
Previous relevant EDC experience required
Previous experience with RTSM/IWRS and ePRO systems
Database development experience
SAS programming experience

Clinical Data Associate Process / Technology Resume Examples & Samples

Apply specialized process/technology knowledge to ensure clinical trial deliverables are consistent and accurate
Act as a primary contact within the Data Sciences and Solutions organization for development and support of process and technology
Communicate and adhere to the global data strategy across the organization as it relates to process and technology
Minimum 3 years experience in clinical data management and/or 5 years experience in drug development in areas intersecting with clinical data management (e.g. clinical operations, statistics, information technology, health outcomes, etc.)
Demonstrated knowledge of data management processes and technology
Demonstrated ability to understand and apply data flow, data quality, data interchange, data mining, and data representation principles
Knowledge of global internal, external and regulatory requirements/expectations (CCS, ICH, GCP, PhRMA, CSUCI etc.)
SCDM certification
Strong interpersonal and leadership skills
Interpersonal/teamwork and communication skills for effective customer consultation
Demonstrated strength in logical thought, problem solving ability and strategic thinking
Ability to communicate and influence within Clinical Data Flow and Technology
Domestic and International travel may be required

Clinical Data Associate Resume Examples & Samples

Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification/ correction to the database
Assist with the reconciliation of central laboratory and/ or third party vendor data (eCRF, eDiary, speciality laboratory, etc.)
Assist with the aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation
Time management skill and ability to adhere to project productivity metrics and timelines
Ability to work in a team environment and collaborate with peers

Clinical Data Associate Resume Examples & Samples

Assist with the reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
Support the training of project staff on project-specific, global, standardized data management processes
2,Demonstrated time management skill and ability to adhere to proejct productivity metrics and timelines
4,Demonstrated interpersonal skills
5,Good oral and written communicaiton skills

Clinical Data Associate Resume Examples & Samples

Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data
Perform reconciliation of the clinical and safety databases
Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
Perform aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation
Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc
Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications
Assist in the creation of data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions
Potentially 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
Potentially serve as client contact for project meetings and CDM status updates
2-3 years DM experiences
1,Minimum 2 years relevent work experience with increasing responsibility in data management knowledge of 1 or more therapeutic areas
5,Potential ability to lead by example data management staff
6,Excellent oral and written communication skills
7,Ability to demonstrate a constructive probelm solving attitude while dealing with time demands, incomplete information or unexpected events