Clinical Data Manager, External Site Studies

Remote, USA Full-time
Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you! This Full-Time role is 100% remote. As a Clinical Data Manager - External Site Studies , you will provide expert oversight of end-to-end data management for external site clinical trials, ensuring data integrity, regulatory compliance, and timely delivery of high-quality datasets using Celerion ’s or Sponsor-provided EDC systems. This role involves cross-functional collaboration, direct Sponsor communication, and active management of project timelines, while also leveraging various database systems and software tools to efficiently manage, organize, and clean clinical data throughout the study lifecycle. Essential Functions: Deliver comprehensive data management services across all study phases 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 Qualifications: 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 Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. Originally posted on Himalayas Apply tot his job
Apply Now

Similar Jobs

[Hiring] Manager/Senior Manager, Clinical Data Sciences @Kura Oncology

Remote, USA Full-time

PRN Clinical Documentation Specialist, First Reviewer

Remote, USA Full-time

Clinical Program Operations Manager, Therapeutics & Innovations

Remote, USA Full-time

Senior Clinical Project Manager/100% remote

Remote, USA Full-time

Clinical Trial Project Manager - Immunology, Rheumatology, Allergy, Dermatology

Remote, USA Full-time

Associate Specialist, Clinical Trials Operations

Remote, USA Full-time

Clinical Project Manager, Execution

Remote, USA Full-time

Director, Clinical Project Management (level dependent on experience)

Remote, USA Full-time

Data Solution Specialist

Remote, USA Full-time

Senior Manager Clinical Pharma Research Programs (Remote) - Neurology

Remote, USA Full-time

**Experienced Data Entry Specialist – Remote Opportunity at blithequark**

Remote, USA Full-time

Webflow Developer for Ongoing Client Projects

Remote, USA Full-time

Remote VA Experienced OP Medical FT & PT Coders

Remote, USA Full-time

Oracle EBS/Fusion consultant 100% Remote

Remote, USA Full-time

Enterprise Account Executive

Remote, USA Full-time

Payroll Specialist (Remote/Global/Work from Anywhere/Entry Level/AI Jobs) Invisible Technologies Inc

Remote, USA Full-time

Assistant Executive Director for Development

Remote, USA Full-time

Experienced Full Stack Customer Service Representative – Remote Customer Care and Financial Services at Blithequark

Remote, USA Full-time

Experienced Remote Customer Service Representative – Airline Travel Support and Customer Experience Enhancement

Remote, USA Full-time

Mfg/Production Planner IV

Remote, USA Full-time
Back to Home