Senior Clinical Data Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee Data Management Activities, Conduct Training, and Manage Client Relationships.

• Create and uphold the Data Management Project Plan (Plan).

• Record any deviations from the Plan, log and report issues, and ensure their resolutions are followed up.

• Serve as the primary contact for daily data management tasks, holding ultimate responsibility for all data management deliverables for assigned projects.

• Act as the main point of contact for discussions regarding data management timelines and deliverables; handle requests for out-of-scope tasks; serve as the first line of contact for technical or procedural inquiries.

• Responsible for planning and executing data management timelines and deliverables; responsible for providing status reports on database and data management activities; contribute to overall project planning, progress tracking, and reporting.

• Support study-level resource planning and management, including reviewing team members’ timesheet reports.

• Assist in client relationship management activities.

• Participate in project bid defense meetings when necessary.

• Deliver training on electronic data capture (EDC) systems, data flow, and quality control processes to clinical trial staff.

• Provide training to new data management personnel regarding data management processes and procedures.

• Conduct quality control reviews of work performed by less experienced data management personnel.

• Help generate project Work Orders and Amendments.

• Aid in managing data flow from and the performance of Third Party Vendors (Non-CRF data vendors).

• Participate in project kick-off meetings, investigators meetings, and regular project management team meetings.

• Offer support for client audits and regulatory inspections, and follow up on audit findings.

• Create and maintain clinical trial Data Management Study Binders.

• Engage in Hands-on Data Management Activities.

• Design and review case report forms (CRFs/eCRFs).

• Develop and review Case Report Form Completion Instructions.

• Generate and review annotated Case Report Forms.

• Design and review Clinical Trial Source Document templates and completion instructions as necessary.

• Develop and maintain data validation specifications.

• Develop and maintain the Data Management Plan (DMP).

• Document any deviations from the DMP.

• Take part in the database design process.

• Participate in EDC User Acceptance Testing (UAT).

• Manage database modifications (post-go-live) due to protocol amendments or study requirements.

• Develop and maintain the Data Quality Review Plan (DQRP).

• Coordinate with programmers to ensure the programming and validation of listings and summary tables as specified in the DQRP.

• Conduct Third Party non-CRF data management activities.

• Review data, issue, and resolve queries.

• Assist Investigative Site personnel in resolving queries.

• Perform Serious Adverse Event reconciliation.

• Help resolve medical coding discrepancies arising from the coding of medical history, adverse events, procedures, and medicinal products.

• Collaborate with the Quality Assurance Department on quality control audits for assigned databases.

• 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.

⛳️ Requirements

• A Bachelor’s or Master’s degree in health and/or pharmaceutical sciences, physical/biological sciences, or chemistry fields.

• Minimum of 5 years of experience in pharmaceutical clinical trial data management or at least 2 years as a Clinical Data Manager II.

• Proven knowledge, experience, and skill in meeting high-quality standards and ensuring a high level of customer satisfaction.

• Demonstrated comprehensive understanding of clinical trial data management concepts, processes, and procedures, alongside relevant issues affecting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.

• Exhibited strong leadership in clinical data management activities and an eagerness to excel in leading data management projects.

🏝️ Benefits

• Work from Home policy

• Professional development opportunities