Clinical Data Manager, External Site Studies

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 phasesEnsure clinical databases are complete, accurate, and compliant with Sponsor and regulatory standardsServe as primary Sponsor contact for data management activitiesLead data management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and progress updatesTrain site staff (CRCs, CRAs, PIs) and client teams on EDC systemsOversee CRF lifecycle from design to final deliveryConduct User Acceptance Testing (UAT) and ensure database setup aligns with specificationsDevelop 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 dataCoordinate database lock and final data deliveryIdentify risks and proactively resolve project issuesProvide exceptional service to internal and external stakeholdersQualifications:Bachelor degree in Business, Science or related field or a combination of education and relevant internal Celerion experience in lieu required1-3 years industry experience requiredKnowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferredKnowledge of SAS and Veeva EDC preferredAbility to manage multiple projects/priorities requiredHigh attention to detail requiredExcellent oral and written communication skills requiredExcellent organizational skills requiredProficiency in MS office applications requiredCelerion Values:       Integrity   Trust   Teamwork   RespectCelerion 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.