Sr Clinical Data Manager

Client- Leading CRO

Hiring- Sr Clinical Data Manager

Responsibilities

Sr Data Management Activities, Perform Training and Client Relationship Management

• Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
• Provide support to client audits and regulatory inspections. Follow up on audit findings.
• Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
• Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
• Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
• Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
• Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
• Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
• Create and maintain clinical trial Data Management Study Binders.
• Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.

Perform Hands-on Data Management Activities

• Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation.
• Design and review Clinical Trial Source Document templates and completion instructions when required.
• Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
• Develop and maintain Data Management Plan (DMP). Document deviations from the DMP.
• Perform Third Party non-CRF data management activities.
• Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
• Perform database soft-lock and hard lock activities.
• Perform Serious Adverse Event reconciliation.
• Develop and maintain data validation specifications.
• Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.

Qualifications And Experience

• A Bachelors’ or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields. USA or Canadian Degree required
• Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.
• At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.

Interested in learning more? Apply today!

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