Senior Clinical Data Manager

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

📋 Description

• Serve as the primary Data Management (DM) contact (Lead DM role) for designated clinical project(s) / program(s), ensuring backup, continuity, prompt responsiveness, and timely task execution. May assist another Lead DM as a backup and/or team member. This may include DM oversight of sponsor programs.

• Supervise the project data entry process, which includes developing data entry guidelines, training, ensuring data entry quality, and managing resources.

• Potentially conduct quality control of data entry tasks.

• Provide insights, evaluate, and manage timelines, ensuring that clinical data management deadlines are met with high quality. Assess resource requirements for assigned projects as needed.

• May develop Case Report Form (CRF) specifications based on the clinical study protocol and coordinate review and feedback from all stakeholders.

• Execute User Acceptance Testing (UAT) for database builds and maintain quality-controlled documentation of the database build. Oversee the overall quality of the clinical database.

• Specify requirements for all types of edit checks (e.g., electronic, manual data review, edit checks, etc.). Supervise the development of edit check specifications and manual data review specifications.

• Accountable for creating, updating, versioning, and maintaining data management documentation. Ensure completeness of data management documentation for the Trial Master File.

• Train clinical research personnel on study-specific CRF, Electronic Data Capture (EDC), and other project-related items as necessary.

• Review and query clinical trial data in accordance with the Data Management Plan.

• Conduct line listing data reviews based on guidance from the sponsor and/or Lead DM.

• Generate patient and study-level status reports and metrics.

• Execute medical coding of medical terms to ensure logical and consistent medical interpretation.

• Coordinate Serious Adverse Event (SAE) and Adverse Event (AE) reconciliation.

• Act as a liaison with third-party vendors, such as external data and EDC vendors, in a project management capacity to support timelines and data-related deliverables.

• May assist with SAS programming and perform quality control of SAS programs utilized in the Data Management department.

• Identify and resolve operational challenges, issues, and barriers for studies using metrics data, audit reports, and input from project team members and stakeholders.

• May support the review and provide feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project.

• Engage in the development and maintenance of Standard Operating Procedures (SOPs) and related process documentation for data management and database management activities.

• May attend strategy meetings, bid defense preparation sessions, bid defenses, capability presentations, and potential client engagement meetings.

• May review Requests for Proposals (RFPs), proposals, and provide project estimates.

• Lead cross-functional and organization-wide initiatives when applicable.

• Train and ensure all data management project team members are adequately trained.

• Communicate with study sponsors, vendors, and project teams as necessary regarding data, database, or other relevant project issues.

• May conduct software demonstrations/training, department/company training sessions, and present at project meetings.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor's degree and/or a combination of relevant experience.

• Over 8 years of experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II within a Clinical Research Organisation, Pharmaceutical, or Biotech company.

• Experience with setup and database migrations.

• Preferably have oncology experience.

• Proficient in Microsoft Office: Word, Excel, PowerPoint, Outlook.

• Exceptional organizational and communication abilities.

• Professional proficiency in the English language, both written and spoken.

• Experience with various clinical database management systems.

• Extensive knowledge of drug, device, and/or biologic development, along with effective data management practices.

• Strong representational abilities and effective oral and written communication skills.

• Strong leadership and interpersonal capabilities.

• Willingness to undertake occasional travel.

🏝️ Benefits

• May require some travel.