Clinical Data Manager – External Site Studies

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

📋 Description

• Provide extensive data management services throughout all phases of study.

• Take full ownership of designated data management studies and deliverables, from initiation to database lock, while proactively identifying risks, addressing issues, communicating status updates, and escalating as necessary.

• Ensure that clinical databases are thorough, precise, and compliant with Sponsor and regulatory requirements.

• Act as the primary contact for the Sponsor regarding data management activities.

• Direct data management communications and collaborate with both internal and external teams to ensure prompt delivery of study milestones and updates on progress.

• Train site personnel (CRCs, CRAs, PIs) and client teams on EDC systems.

• Manage the CRF lifecycle from its design to final delivery.

• Conduct User Acceptance Testing (UAT) to ensure database configurations meet specifications.

• Create and oversee essential study documents (e.g., Data Management Plan, CRF Completion Guidelines, Validation Plans, SAE Reconciliation Plans).

• Review and clean clinical data, manage queries, and reconcile data from third-party sources.

• Coordinate the database lock and ensure the final data delivery.

• Identify potential risks and take proactive measures to address project issues.

• Deliver outstanding service to both internal and external stakeholders.

⛳️ Requirements

• Bachelor’s degree in Business, Science, or a related field, or a combination of education and relevant internal Celerion experience in lieu is required.

• 1-3 years of industry experience is required.

• Familiarity with Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part 11 is preferred.

• Knowledge of SAS and Veeva EDC is preferred.

• Ability to manage multiple projects and prioritize tasks is required.

• A strong attention to detail is required.

• Excellent verbal and written communication skills are required.

• Exceptional organizational skills are required.

• Proficiency in MS Office applications is required.

🏝️ Benefits

• Celerion Values: Integrity, Trust, Teamwork, Respect.

• Equal Opportunity Employer.