Clinical Data Manager II/Senior Clinical Data Manager

The Senior Clinical Data Manager oversees all aspects of clinical trial data management from start-up to post database lock, ensuring compliance with SOPs, regulatory directives, and study guidelines. The role involves database development, testing, and coordination with vendors and stakeholders.

Location: Remote (US)

Salary: $91,500—$166,100 USD

Responsibilities

• Manage all aspects of clinical trial data management from study start-up to post database lock.
• Oversee project data entry process, develop data entry guidelines, and ensure data quality.
• Perform quality control of data entry and manage timelines to meet deadlines.
• Develop CRF specifications and coordinate review with stakeholders.
• Assist in building and maintaining clinical databases, conduct UAT, and oversee database quality.
• Specify requirements for edit checks and oversee their development.
• Create, revise, and maintain data management documentation and ensure completeness for the Trial Master File.
• Train clinical research personnel on CRF, EDC, and related items.
• Review and query clinical trial data, perform line listing data review, and run status reports.
• Perform medical coding and coordinate SAE/AE reconciliation.
• Liaise with third-party vendors and support SAS programming and QC.
• Identify operational problems and troubleshoot issues.
• Review protocols, SAPs, and CSRs as needed.
• Develop and maintain SOPs and process documentation.
• Participate in strategy and client engagement meetings, review proposals, and provide project estimates.
• Provide leadership for cross-functional initiatives and train project team members.
• Communicate with sponsors, vendors, and project teams.
• Present software demos/trainings and participate in meetings.
• Travel as needed.
• Perform other duties as assigned.

Requirements

• 8+ years’ experience as a Senior Clinical Data Manager and 5 years as a Clinical Data Manager II.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Ability to handle various clinical research tasks.
• Excellent organizational and communication skills.
• Professional use of English, both written and oral.
• Experience with clinical database management systems.
• Broad knowledge of drug, device, and biologic development and data management practices.
• Strong communication, leadership, and interpersonal skills.
• Ability to undertake occasional travel.

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance and disability benefits
• Parental leave
• Paid time off for sick leave and vacation

Additional Information

• Position is 100% remote with a preference for East Coast candidates.
• Estimated salary range: $91,500—$166,100 USD.
• Travel may be required.
• The role involves leadership, coordination, and communication with various stakeholders.
• The position emphasizes compliance with SOPs, regulatory directives, and study guidelines.