Senior Clinical Data Manager

This is a fully remote position, open to applicants in Poland, +4 more countries.

📋 Description

• Oversee all elements of the clinical trial data management process from the initiation of the study to the post-database lock phase for designated projects.

• Act as the principal Data Management contact and Lead DM for allocated clinical projects/programs.

• Supervise project data entry, focusing on guidelines, training, quality, and resource allocation.

• Evaluate and manage timelines, deadlines, and resource requirements.

• Create CRF specifications and coordinate the review with stakeholders.

• Execute database build UAT and maintain controlled documentation for database builds.

• Ensure the quality of clinical databases and establish edit-check specifications.

• Develop, modify, and maintain data management documentation along with the completeness of the Trial Master File.

• Provide training for clinical research personnel and members of the data management project team.

• Analyze and query clinical trial data according to the Data Management Plan.

• Conduct line-listing data reviews and report on patient/study status and metrics.

• Carry out medical coding and manage SAE/AE reconciliation.

• Collaborate with third-party data and EDC vendors regarding timelines and deliverables.

• Resolve operational issues using metrics, audit reports, and input from stakeholders.

• Contribute to the development and maintenance of SOPs.

• Engage with sponsors, vendors, and project teams concerning data and database matters.

• May assist with SAS programming and quality assurance.

• May review protocols, SAPs, CSRs, RFPs, proposals, and project estimates.

• Provide leadership for cross-functional initiatives.

• May participate in meetings, presentations, software demonstrations, and training sessions.

• 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 Sr. Clinical Data Manager or at least 5 years as a Clinical Data Manager II within a Clinical Research Organisation, Pharmaceutical, or Biotech company.

• Experience in setting up and migrating databases.

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

• Exceptional organizational and communication skills.

• Professional proficiency in the English language, both written and spoken.

• Experience with various clinical database management systems.

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

• Strong representational abilities, capable of effective oral and written communication.

• Excellent leadership and interpersonal skills.

• Willingness to undertake occasional travel.

• Candidates must have legal authorization to work in the employment country without employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Vacation time.