Senior Clinical Data Manager

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

📋 Description

• Oversee data management tasks for designated clinical research initiatives.

• Create and uphold Data Management Project Plans, Data Management Plans, and Data Quality Review Plans.

• Act as the main point of contact for daily data management operations, timelines, deliverables, and any technical or procedural challenges.

• Strategize and execute data management timelines and deliverables; provide status updates and assist in project planning and progress monitoring.

• Aid in resource allocation, client relationship management, project proposals, work orders, amendments, and vendor coordination.

• Educate clinical trial staff on EDC systems, data flow, quality assurance processes, and data management protocols.

• Conduct quality control assessments of work performed by less experienced data management staff.

• Engage in project kick-off meetings, as well as meetings with investigators and the project management team.

• Assist with client audits and regulatory inspections; address audit findings promptly.

• Develop and maintain clinical trial Data Management Study Binders.

• Design and evaluate CRFs/eCRFs, completion guidelines, annotated CRFs, and source document templates.

• Contribute to database design and EDC User Acceptance Testing.

• Manage database modifications post-go-live due to protocol changes or study requirements.

• Oversee programming and validation of listings and summary tables.

• Handle third-party non-CRF data management tasks.

• Review data, address queries, and assist investigative site personnel with query resolution.

• Conduct Serious Adverse Event reconciliations and assist with discrepancies in medical coding.

• Collaborate with Quality Assurance on database quality control audits.

• Execute database soft-lock and hard-lock procedures.

• Prepare final archival of data management documentation and assist with the archiving of clinical trial records.

⛳️ Requirements

• Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological sciences, or chemistry.

• Minimum of 5 years in pharmaceutical clinical trial data management, or at least 2 years as a Clinical Data Manager II.

• Comprehensive understanding of clinical trial data management concepts, processes, procedures, and associated challenges.

• Familiarity with pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.

• Proven leadership in clinical data management activities.

• Capacity to lead data management projects effectively.

• Commitment to maintaining high quality standards and ensuring high levels of customer satisfaction.

🏝️ Benefits

• Work from Home policy.

• Home-based office setup.

• Accommodations available for candidates participating in any stage of the recruitment and selection process.