Senior Clinical Data Manager

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Oversee all facets of the clinical trial data management process from study initiation to post-database lock for designated projects.

• Act as the primary Data Management liaison and Lead Data Manager for assigned clinical projects and programs.

• Supervise project data entry, including guidelines, training, quality assurance, and resource allocation.

• Evaluate and manage timelines, deadlines, and resource requirements.

• Create CRF specifications and facilitate stakeholder review and feedback.

• Conduct user acceptance testing (UAT) for database builds and maintain controlled documentation for database construction.

• Ensure the quality of clinical databases and develop edit-check specifications.

• Generate, update, version, and sustain data management documentation and the completeness of the Trial Master File.

• Provide training to clinical research staff and members of the data management project team.

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

• Execute line-listing data reviews and prepare reports on patient/study-level status and metrics.

• Conduct medical coding and coordinate reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).

• Collaborate with third-party data and Electronic Data Capture (EDC) vendors on timelines and data deliverables.

• Support SAS programming and quality control of SAS programs.

• Identify and resolve operational issues using metrics, audit reports, and feedback from stakeholders.

• Review and give feedback on protocols, Statistical Analysis Plans, and Clinical Study Reports as necessary.

• Engage in the development and maintenance of standard operating procedures (SOPs) and process documentation.

• Participate in strategy meetings, bid-defense preparations, capability presentations, and client engagement meetings.

• Evaluate RFPs, proposals, and project estimates.

• Provide leadership for cross-functional and organization-wide initiatives.

• Communicate with sponsors, vendors, and project teams regarding data and database challenges.

• Deliver software demonstrations, training sessions, and participate in project meetings.

• Carry out additional duties as assigned; occasional travel may be required.

⛳️ Requirements

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

• Over 8 years of experience as a Senior Clinical Data Manager or at least 5 years as a Clinical Data Manager II in a Clinical Research Organization, Pharmaceutical, or Biotech company.

• Experience in setting up and migrating databases.

• Oncology experience is preferred.

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

• Professional command of the English language, both written and spoken.

• Experience with various clinical database management systems.

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

• Excellent representational, organizational, communication, leadership, and interpersonal skills.

• Willingness to travel occasionally.

• Must possess legal authorization to work in the country of employment without employer sponsorship.

🏝️ Benefits

• Regular full-time employment.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.

• No employer sponsorship required; candidates must be legally authorized to work in the country of employment.