Clinical Data Manager II / Senior Clinical Data Manager

Company: Precision Medicine Group

Location: UK, Poland, Hungary, Romania, Serbia, or Slovakia (Remote)

About the Role:
Precision Medicine Group is seeking a highly skilled Clinical Data Manager II or Senior Clinical Data Manager to join our global team. This role is responsible for managing all facets of the clinical trial data management process, from study initiation through to database lock, ensuring adherence to Standard Operating Procedures (SOPs/WIs), regulatory directives, and study-specific plans. You will play a crucial part in overseeing database development and testing.

Responsibilities:

• Serve as the primary Data Management (DM) contact for assigned clinical projects or programs, ensuring continuity, responsiveness, and timely task completion. May also support other Lead DMs or oversee sponsor programs.
• Oversee project data entry processes, including developing data entry guidelines, training, and ensuring data quality and resource allocation.
• May perform quality control of data entry.
• Provide input on, assess, and manage project timelines, ensuring clinical data management deadlines are met with high quality. Assess resource needs for assigned projects.
• May develop Case Report Form (CRF) specifications from clinical study protocols and coordinate stakeholder reviews.
• Conduct User Acceptance Testing (UAT) for database builds and maintain quality-controlled documentation. Oversee the overall quality of the clinical database.
• May specify requirements for various edit check types (electronic, manual data review) and oversee the development of edit check and manual data review specifications.
• Create, revise, version, and maintain data management documentation, ensuring completeness for the Trial Master File.
• Train clinical research personnel on study-specific CRFs, Electronic Data Capture (EDC) systems, and other project-related items.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data reviews based on guidance from sponsors and/or the Lead DM.
• Run patient and study-level status and metric reports.
• Perform medical coding of medical terms for consistency and logic.
• Coordinate SAE/AE reconciliation.
• Liaise with third-party vendors (e.g., external data and EDC vendors) in a project management capacity to support timelines and data 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.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs).
• Participate in the development and maintenance of SOPs and related process documentation for data and database management.
• May attend strategy meetings, bid defense preparations, capability presentations, and client engagement meetings.
• May review Requests for Proposals (RFPs) and proposals, providing project estimates.
• Provide leadership for cross-functional and organization-wide initiatives.
• Train data management project team members and ensure sufficient training.
• Communicate with study sponsors, vendors, and project teams regarding data, database, or other project issues.
• May present software demonstrations/trainings and department/company training sessions.
• May require occasional travel.

Qualifications:

• Bachelor's degree or equivalent combination of education and experience.
• 8+ years of experience as a Sr. Clinical Data Manager OR 5+ years as a Clinical Data Manager II in a Clinical Research Organization (CRO), pharmaceutical, or biotech company.
• Experience with setup and database migrations.
• Oncology experience is preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
• Excellent organizational and communication skills.
• Professional proficiency in English (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 and ability to communicate effectively.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.

Equal Opportunity Employer:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other protected characteristics.