Clinical Data Manager II / Senior Clinical Data Manager

This is a fully remote position, open to applicants in Poland.

📋 Description

• Serve as the primary contact for Data Management (DM) in assigned clinical project(s) / program(s) (Lead DM role), ensuring backup, continuity, responsiveness, and timely completion of tasks. May assist another Lead DM as backup and/or team member. Responsibilities may include oversight of sponsor programs.

• Supervise the project data entry process, including the development of data entry guidelines, training, quality assurance of data entry, and resource allocation.

• Potentially perform quality control checks on data entry.

• Contribute to timeline assessment and management, ensuring clinical data management deadlines are met with high quality. Evaluate resource needs for assigned projects as necessary.

• May create CRF specifications based on the clinical study protocol and coordinate stakeholder review/feedback.

• Conduct user acceptance testing (UAT) for database builds and maintain quality-controlled documentation of the database build. Oversee the overall quality of the clinical database.

• Specify requirements for all types of edit checks (e.g., electronic, manual data review) and oversee the development of edit check and manual data review specifications.

• Responsible for creating, updating, versioning, and maintaining data management documentation, ensuring completeness for the Trial Master File.

• Train clinical research staff on study-specific CRF, EDC, and other project-related topics as required.

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

• Conduct line listing data reviews as per guidance from the sponsor and/or Lead DM.

• Generate patient and study level status reports and metrics.

• Perform medical coding of medical terms to ensure logical consistency and accuracy.

• Coordinate reconciliation of Serious Adverse Events (SAE) and Adverse Events (AE).

• Collaborate with third-party vendors, including external data and EDC vendors, in a project management capacity to support timelines and data-related deliverables.

• May assist with SAS programming and quality control of SAS programs utilized in the Data Management department.

• Identify and resolve operational issues, obstacles, and barriers for studies based on metrics data, audit reports, and feedback from project team members and 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 upkeep of Standard Operating Procedures (SOPs) and related process documentation for data management and database management activities.

• May attend strategy meetings, bid defense preparations, bid defenses, capability presentations, and potential client engagement meetings.

• May review Requests for Proposals (RFP), proposals, and provide project estimates.

• Lead cross-functional and organization-wide initiatives as applicable.

• Train and ensure that all data management project team members receive adequate training.

• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.

• May deliver software demonstrations/trainings, department/company training sessions, or presentations at project meetings.

• Some travel may be required.

• Perform additional duties as assigned.

⛳️ Requirements

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

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

• Experience with database setup and migrations.

• Oncology experience is preferred.

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

• Exceptional organizational and communication skills.

• Professional proficiency in English, both written and spoken.

• Experience utilizing various clinical database management systems.

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

• Strong representation skills and ability to communicate effectively, both orally and in writing.

• Strong leadership and interpersonal skills.

• Willingness to undertake occasional travel.

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Vacation time.