Clinical Data Manager – External Site Studies – Remote

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.

Celerion offers one of the most experienced clinical pharmacology research networks in the industry.

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.

The Clinical Data Manager
– External Site Studies provides comprehensive data management expertise and manages end-to-end delivery of data management services.

Responsible for the integrity of the data entered into the clinical database using Celerion’s EDC and/or Sponsor provided EDC database and/or Paper CRF.

Ensures database is complete, accurate and consistent and meets quality standards required by Sponsors and regulatory bodies.

Collaborates and participates in multidisciplinary teams involved in setting up, running and reporting clinical trials.

Responsible for Sponsor contact, project communication and timeline management for all data management functions.

Essential Functions: Oversight of all clinical data management activities for assigned studies in accordance with Management Standard Operating Procedures (SOP) and Procedure Guides (PG) Primary Sponsor contact for data management processes on study Responsible for regular communication of study progress with internal and external project team Responsible for CRF Design and EDC Database Specifications Ensure database is set up per specifications and perform User Acceptance Testing (UAT) of clinical database as needed Coordinate creation and archiving of all Data Management documents and study materials as required per SOP and study needs Manage clinical data cleaning and delivery activities up to and including database lock Responsible for Query Management and third party data reconciliations Proactively ensure on-time delivery of study deliverables and assess project activities and identify issues and/or risk 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 EDC Systems preferred (TrialMaster, Veeva CDMS etc.) Ability to manage multiple projects/priorities required High attention to detail and excellent organizational skills required Excellent oral and written communication skills required Proficiency in MS office applications required Celerion Values: Integrity Trust Teamwork Respect Are you ready to join our team?

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.