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Job description

We are seeking a Senior Clinical Data Manager to work collaboratively in a fast-paced, cross-functional team environment. This team member will oversee clinical trial data and help set priorities to ensure that all data management procedures are executed with accuracy and timeliness. As a subject matter expert, the incumbent will work on multi-functional teams and supports the clinical data & programming team.

Responsibilities

• Assist in the development and maintenance of the Data Management Plan (DMP). 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 the planning and implementing of 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 training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
• Participate in regular project management team meetings.
• Assist in the design and review of case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
• Assist in the development and maintenance of data validation specifications.
• Assist in the development and maintenance of the Data Management Plan (DMP) and Data Validation Plan (DVP). Document deviations from the DMP.
• Participate in the database design process. Participate in EDC User Acceptance Testing (UAT).
• Manage the process of database modifications (after go-live) due to protocol amendments or study needs.
• Perform Third Party non-CRF data management activities.
• Review data, issue and resolve queries. Assist Investigative Site personnel with resolving queries.
• Perform Serious Adverse Event reconciliation.
• Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
• Perform database soft-lock and hard lock 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.

About You

• Bachelor’s degree in Health Sciences, Clinical Data Management, Nursing or other relevant scientific field, or equivalent work experience is required.
• 5+ years relevant experience within the Pharmaceutical, CRO or Biotech industry, or equivalent is required, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.
• Demonstrated in-depth understanding of clinical trial data concepts, processes and procedures, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards
• Demonstrated leadership in clinical data management activities and a desire to excel in leading data management projects.

Job Types: Full-time, Fixed term contract
Contract length: 12 months

Pay: $70,000.00-$90,000.00 per year

Schedule:

• 8 hour shift

Education:

• Bachelor's Degree (preferred)