Clinical Data Manager II/Senior Clinical Data Manager

Remote position based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.

About the role

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 follows Standard Operating Procedures (SOPs), Work Instructions (WIs), regulatory directives, study-specific plans, and guidelines. Responsibilities include overseeing and/or performing database development and testing.

Responsibilities

• 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 as backup or team member, including DM oversight of sponsor programs.
• Oversee the project data entry process, including development of data entry guidelines, training, data entry quality, and resourcing.
• Perform quality control of data entry.
• Provide input, assess, and manage timelines to ensure clinical data management deadlines are met with quality. Assess resource needs for assigned projects as needed.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from all stakeholders.
• Conduct database build User Acceptance Testing (UAT) and maintain quality-controlled database build documentation.
• Oversee the overall quality of the clinical database. 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.
• Create, revise, version, and maintain data management documentation. Oversee completeness of data management documentation for the Trial Master File.
• Train clinical research personnel on study-specific CRF, 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 Serious Adverse Event (SAE)/Adverse Event (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.
• 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 stakeholders.
• 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 SOPs and corresponding process documentation related to data management and database management activities.
• Attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and potential client engagement meetings.
• Review Request for Proposals (RFP), 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 are sufficiently trained.
• Communicate with study sponsors, vendors, and project teams regarding data, database, or other relevant project issues.
• Present software demonstrations/trainings, department/company training sessions, and project meetings.
• Occasional travel may be required.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree and/or a combination of related experience.
• 8+ years’ experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II working for a Clinical Research Organization, Pharmaceutical, or Biotech company.
• Experience with database set-up and 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 and ability to communicate effectively orally and in writing.
• Strong leadership and interpersonal skills.
• Ability to undertake occasional travel.