[Remote] Clinical Data Manager, External Site Studies

Note: The job is a remote job and is open to candidates in USA. Celerion is committed to swift, exceptional clinical research through translational medicine. In this role, you will provide expert oversight of end-to-end data management for external site clinical trials, ensuring data integrity and regulatory compliance while collaborating with various teams and managing project timelines.ResponsibilitiesDeliver comprehensive data management services across all study phasesIndependently own assigned data management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating when appropriateEnsure 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 stakeholdersSkillsBachelor degree in Business, Science or related field or a combination of education and relevant internal Celerion experience in lieu required1-3 years industry experience requiredAbility to manage multiple projects/priorities requiredHigh attention to detail requiredExcellent oral and written communication skills requiredExcellent organizational skills requiredProficiency in MS office applications requiredKnowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferredKnowledge of SAS and Veeva EDC preferredCompany OverviewCelerion, a leader in early clinical research, delivers Applied Translational Medicine. It was founded in 2010, and is headquartered in Lincoln, Nebraska, USA, with a workforce of 1001-5000 employees. Its website is https://celerion.com/.Company H1B SponsorshipCelerion has a track record of offering H1B sponsorships, with 1 in 2026, 5 in 2025, 7 in 2024, 5 in 2023, 3 in 2022, 6 in 2021, 5 in 2020. Please note that this does not guarantee sponsorship for this specific role.