Clinical Data Manager – External Site Studies

🕒 4 days ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

📊 Data Scientist

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Celerion

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1971

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Celerion is a global leader in clinical research services with a focus on accelerating drug development through translational medicine. The company offers a range of services including early phase clinical trials, bioanalytical sciences, PK/PD studies, biomarkers, and regulatory affairs. Celerion is dedicated to getting drugs to market faster by leveraging their experience and innovative research strategies. Their expertise covers various therapeutic areas such as oncology, metabolic and respiratory diseases, biosimilars, and vaccines. With over 40 years of experience, Celerion has been recognized for their leadership in the clinical research organization (CRO) space and is committed to science and technology-driven innovations that advance healthcare solutions globally.

📋 Description

• Deliver comprehensive data management services across all study phases • Independently own assigned data management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating when appropriate • Ensure clinical databases are complete, accurate, and compliant with Sponsor and regulatory standards • Serve as primary Sponsor contact for data management activities • Lead data management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and progress updates • Train site staff (CRCs, CRAs, PIs) and client teams on EDC systems • Oversee CRF lifecycle from design to final delivery • Conduct User Acceptance Testing (UAT) and ensure database setup aligns with specifications • Develop and manage 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 third-party data • Coordinate database lock and final data delivery • Identify risks and proactively resolve project issues • Provide exceptional service to internal and external stakeholders

🎯 Requirements

• Bachelor degree in Business, Science or related field or a combination of education and relevant internal Celerion experience in lieu required • 1-3 years industry experience required • Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred • Knowledge of SAS and Veeva EDC preferred • Ability to manage multiple projects/priorities required • High attention to detail required • Excellent oral and written communication skills required • Excellent organizational skills required • Proficiency in MS office applications required

🏖️ Benefits

• Celerion Values: Integrity Trust Teamwork Respect • Equal Opportunity Employer