Clinical Data Manager

Job Summary

The Clinical Data Manager is responsible for supporting all data management activities for research studies in compliance with departmental SOPs and all regulatory guidelines. The Clinical Data Manager works as an integral part of a cross-functional team throughout the lifecycle of the research study from design through final analysis and study closeout by collaborating with the project teams and providing data review, analytics, and reports.   This position will ensure the clinical study data is collected, handled, and validated in an appropriate and consistent manner to ensure high quality data is delivered to support the statistical analysis.

The Clinical Data Manager is responsible for the following activities: protocol review, CRF design and development, development of database specifications, development of edit check specifications, development of the Data Management Plan, development of CRF Completion Guidelines, User Acceptance Testing (UAT), data review, query generation and resolution, data reconciliation, identification and review of protocol deviations, review of adverse events, and maintenance of study documentation in the electronic Trial Master File (eTMF).
 

Job Details/Responsibilities

• Review and provide input to study protocols ensuring data collection requirements are logical, consistent, and support the study endpoints.
• Establish and maintain conducive relationships with cross functional partners to ensure the execution of research studies.
• Partner with therapeutic area personnel to ensure timely and high-quality data management deliverables are produced in support of business goals.
• Accountable and responsible to ensure the delivery of high-quality Data Management deliverables and activities from protocol review through database closure and archiving.
• Design high quality CRFs in consultation with cross functional partners that align to the data collection requirements identified in the study protocol, align with internal standards, and accurately reflect study endpoints.
• Develop and define edit check specifications. 
• Ensure the database design meets the requirements for data entry and reporting as per the specifications.
• Develop and maintain the Data Management Plan throughout the life of the study.
• Communicate with study team members and sites on outstanding items.
• Develop the Completion Guidelines to aid the site personnel to complete the CRFs.
• Perform User Acceptance Testing to ensure the quality and integrity of the database design, edit checks, and programming prior to the database being released to collect data.
• Identify data trends and work with study personnel to ensure high quality data is being collected.
   

Job Responsibilities (continued)

• Identify, document, and implement solutions to data management issues in conjunction with the DM and cross-functional teams.
• Generate and provide study reports to the applicable study team members as appropriate.
• Assist CRAs with preparation for monitoring visits.
• Perform data review and query generation/resolution including third party data reconciliation to ensure the delivery of high-quality data.
• Maintains complete and accurate records of study data, reports, and documentation and files in the eTMF as appropriate to ensure compliance with departmental SOPs and all regulatory guidelines.
• Prepare reports of clinical studies for internal validation and cross validation studies.
• Train internal and external personnel in the CDMS system(s), technology, applications, and Data Management process.
• Demonstrates an understanding of database design, data structure, design constraints and cross-functional needs to support clinical trials. 
• Contribute to the development of DM SOPs, Business Guidance, Work Instructions, and Standards.
• Attend and participate in project and functional group meetings as required.
• Perform routine audits of study files and records to ensure compliance with standards.
• May provide mentoring and coaching to data management team members including new hires and junior associates
• Other duties as assigned.

Working Conditions/Physical Requirements

• Demonstrates an understanding of database design, data structure, design constraints and cross-functional needs to support clinical trials.
• Highly organized with the ability to prioritize and manage multiple activities concurrently.
• Working knowledge of the clinical research process and regulatory requirements.
• Knowledge of data management processes and industry standards.
• Ability to work independently with minimal supervision.
• Ability to establish positive working relationships and rapport with both internal and external team members.
• Ability to anticipate and identify data trends, issues, problems and delays and escalate them appropriately to minimize their impact to the study.
• Experience with Electronic Data Capturing Systems (e.g., Medidata RAVE, Oracle Clinical, Veeva, OpenClinica, iMedNet, Medrio, etc.) required.
• Knowledge and experience with clinical data reporting tools such as JReview.

• Knowledge of and skill in using Microsoft Office suite (e.g., Visio, PowerPoint, Word, Excel, OneNote, Outlook, TEAMS, etc.).

• Understanding of ICH, ISO, GCP, and GDP guidelines.
• Effective project management skills.
• Effective analytical and problem-solving skills. 
• Effective interpersonal, verbal, and written communication skills and be able to effectively work across departments with diverse needs.
• Effective organizational and time management skills.
• Ability to work within a cross-functional team through the various stages of the product development process.
• Ability to work in a highly matrixed team environment.
• Ability to adapt to changing priorities.
• Basic knowledge of SQL preferred.
• Basic understanding of SAS concepts preferred.

Knowledge, Skills and Abilities (KSA)

• Demonstrates an understanding of database design, data structure, design constraints and cross-functional needs to support clinical trials.
• Highly organized with the ability to prioritize and manage multiple activities concurrently.
• Working knowledge of the clinical research process and regulatory requirements.
• Knowledge of data management processes and industry standards.
• Ability to work independently with minimal supervision.
• Ability to establish positive working relationships and rapport with both internal and external team members.
• Ability to anticipate and identify data trends, issues, problems and delays and escalate them appropriately to minimize their impact to the study.
• Experience with Electronic Data Capturing Systems (e.g., Medidata RAVE, Oracle Clinical, Veeva, OpenClinica, iMedNet, Medrio, etc.) required.
• Knowledge and experience with clinical data reporting tools such as JReview.
• Knowledge of and skill in using Microsoft Office suite (e.g., Visio, PowerPoint, Word, Excel, OneNote, Outlook, TEAMS, etc.).
• Understanding of ICH, ISO, GCP, and GDP guidelines.
• Effective project management skills.
• Effective analytical and problem-solving skills.
• Effective interpersonal, verbal, and written communication skills and be able to effectively work across departments with diverse needs.
• Effective organizational and time management skills.
• Ability to work within a cross-functional team through the various stages of the product development process.
• Ability to work in a highly matrixed team environment.
• Ability to adapt to changing priorities.
• Basic knowledge of SQL preferred.
• Basic understanding of SAS concepts preferred.

Qualifications/ Background Experiences

• Undergraduate degree in a Math, Computer Science, or Life Sciences field required or equivalent combination of education, training and industry related experience. 
• 3 or more years’ experience required supporting clinical research studies within a data management, data analytics, or a data reporting function.