Job Opportunity: Clinical Data Manager II / Senior Clinical Data Manager

About Us

We are a global team seeking a Clinical Data Manager II or Senior Clinical Data Manager to join our organization. We offer the flexibility to consider candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.

Position Summary

The Clinical Data Manager II/Senior Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. This role adheres to Standard Operating Procedures/Work Instructions (SOPs/WIs), regulatory directives, and study-specific plans and guidelines. The position also involves overseeing and/or performing database development and testing.

Essential Functions

• Serve as the primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s)/program(s), ensuring backup, continuity, responsiveness, and timely task completion. May support another Lead DM or work as a team member. May include DM oversight of sponsor programs.
• Oversee project data entry processes, including developing data entry guidelines, training, ensuring data entry quality, and managing resourcing.
• May perform quality control of data entry.
• Provide input, assess, and manage timelines. Ensure clinical data management deadlines are met with quality. Assess resource needs for assigned projects as needed.
• May develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• 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 (e.g., electronic, manual data review, edit checks). Oversee development of edit check specifications and manual data review specifications.
• Responsible for creating, revising, appropriately versioning, and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on study-specific CRFs, EDC, and other project-related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on guidance provided by the sponsor and/or Lead DM.
• Run patient and study-level status and metric reporting.
• Perform medical coding of medical terms to ensure 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 the Data Management department.
• Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSRs), if required by the project.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities.
• 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, where applicable.
• Train and ensure all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
• May present software demonstrations/trainings, department/company training sessions, and present at project meetings.
• May require occasional 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, Pharmaceutical, or Biotech company.
• Experience with setup and database migrations.
• Oncology experience preferred.
• Proficiency in Microsoft Office Suite (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.

About Precision Medicine Group

Precision Medicine Group is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace. We welcome applications from all qualified individuals regardless of race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. If you require reasonable accommodation during the application process, please contact us at QuestionForHR@precisionmedicinegrp.com.

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