Clinical Data Manager II/Senior Clinical Data Manager

Clinical Data Manager II / Senior Clinical Data Manager

Company: Precision Medicine Group
Location: UK, Poland, Hungary, Romania, Serbia, or Slovakia (Remote)

Position Summary:

We are hiring a Clinical Data Manager II or Senior Clinical Data Manager to join our global team. This role is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects, adhering to Standard Operating Procedures/Work Instructions (SOPs/WIs) and regulatory directives. The position will also oversee and/or perform database development and testing.

Essential Functions:

• Serve as the Primary Data Management (DM) contact (Lead DM role) for assigned clinical projects/programs, ensuring backup, continuity, responsiveness, and timely task completion. May support another Lead DM or oversee DM for sponsor programs.
• Oversee the project data entry process, including developing data entry guidelines, training, data entry quality, and resourcing. May perform quality control of data entry.
• Provide input, assess, and manage timelines, ensuring clinical data management deadlines are met with quality. Assess resource needs for assigned projects.
• May develop CRF specifications from the clinical study protocol and coordinate stakeholder review.
• Conduct database build UAT and maintain quality-controlled database build documentation. Oversee the overall quality of the clinical database.
• May specify requirements for all edit check types (electronic, manual data review, edit checks). Oversee the development of edit check specifications and manual data review specifications.
• Create, revise, version, and maintain data management documentation. Oversee the completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on study-specific CRF, EDC, and other project-related items.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on sponsor and/or Lead DM guidance.
• Run patient and study-level status and metric reporting.
• Perform medical coding of medical terms for medical logic and consistency.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors (e.g., external data and EDC vendors) in a project manager capacity to support timelines and data-related deliverables.
• May assist with SAS programming and quality control of SAS programs used in Data Management.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and project team input.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs).
• Participate in the development and maintenance of SOPs and related process documentation for data management and database management.
• May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings.
• May review Request for Proposals (RFPs), proposals, and provide project estimates.
• Provide leadership for cross-functional and organization-wide initiatives.
• Train and ensure all data management project team members are sufficiently trained.
• Communicate with study sponsors, vendors, and project teams regarding data, database, or other project issues.
• May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
• May require some travel.
• Perform other duties as assigned.

Qualifications:

• Bachelors degree and/or a combination of related experience.
• 8+ years of experience as a Sr. Clinical Data Manager OR 5+ years as a Clinical Data Manager II working for a Clinical Research Organization (CRO), Pharmaceutical, or Biotech company.
• Experience with setup and database migrations.
• Oncology experience preferred.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Excellent organizational and communication skills.
• Professional use of the English language; both written and oral.
• Experience utilizing various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.
• Strong representational skills; ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

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