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 period following the database lock for designated projects.

• Act as the main Data Management contact and Lead DM for the clinical projects/programs assigned to you.

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

• Contribute to and manage timelines, deadlines, and resource requirements.

• Develop specifications for CRFs and coordinate the review and feedback from stakeholders.

• Conduct user acceptance testing for database builds and maintain documentation for quality-controlled database builds.

• Ensure the quality of clinical databases and oversee specifications for edit-checks.

• Create, update, version, and maintain data management documentation as well as Trial Master File documentation.

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

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

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

• Carry out medical coding and coordinate the reconciliation of serious adverse events/adverse events.

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

• Assist with SAS programming and the quality control of SAS programs.

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

• Review and provide insights on protocols, Statistical Analysis Plans (SAPs), and Clinical Study Reports (CSRs) as needed.

• Engage in the development of Standard Operating Procedures (SOPs) and process documentation.

• Support strategy meetings, bidding defenses, capability presentations, client interactions, RFP reviews, and project estimations.

• Lead initiatives that span multiple functions and the organization as appropriate.

• Communicate effectively with sponsors, vendors, and project teams regarding any project-related issues.

• Conduct software demonstrations, training sessions, and project meetings.

• Perform additional duties as required.

⛳️ Requirements

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

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

• Experience with database setups and migrations.

• Preferred background in oncology.

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

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

• Experience with various clinical database management systems.

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

• Strong skills in representation, organization, communication, leadership, and interpersonal relations.

• Willingness to travel occasionally.

• Must possess legal authorization to work in the country of employment without the need for employer sponsorship.

🏝️ Benefits

• Discretionary annual bonus.

• Private medical insurance.

• MultiSport Card.

• Life insurance.

• Pension plan.

• Home working allowance.

• Vacation time.

• Opportunities for travel.