Manage end-to-end data management for external-site clinical trials using sponsor or Celerion EDC. Own databases from startup through lock, ensure data integrity and regulatory compliance, lead Sponsor communications, train site staff, conduct UAT, develop data management documents, clean and reconcile data, and coordinate final data delivery.
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.
This role is ideal for a proactive data management professional who demonstrates strong ownership of assigned studies, sound judgment in day-to-day decision-making, effective prioritization across multiple deliverables, and the ability to escalate issues appropriately.
Essential Functions:
- 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
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
#LI-Remote
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.
Celerion Richmond, California, USA Office
Richmond, United States
Similar Jobs
Cloud • Security • Software • Cybersecurity • Automation
Serve as a strategic People Business Partner to senior Product and Marketing leaders, designing and executing talent, performance, succession, and organizational strategies. Drive workforce planning, calibrations, promotions, and compensation reviews; partner with TA, Rewards, and Development; surface people analytics to inform leadership decisions; support globally distributed teams and navigate change with both strategic guidance and hands-on execution.
Big Data • Cloud • Software • Database
Lead go-to-market positioning and messaging for MongoDB's Public Sector vertical (focusing on federal/FedRAMP High), create sales enablement and customer-facing content, partner cross-functionally with compliance, product, sales, and partners, run competitive and win/loss analysis, and expand the narrative to SLED in Phase 2.
Top Skills:
AWSCio-Sp3CmmcDocument DatabaseDod Impact LevelsFedramp HighGCPGsa SchedulesGsa SewpIntegrated AiItarAzureMongoDBMongodb AtlasSearchStaterampStream ProcessingVector Search
Edtech • Healthtech • HR Tech • Information Technology • Professional Services • Software • Telehealth
Sell Rethink Ed solutions to K-12 districts across a multi-state territory. Prospect and develop new business, manage the full sales cycle, engage senior district leaders, maintain an accurate Salesforce pipeline, execute territory plans, deliver presentations, and meet assigned sales quotas while expanding Rethink's footprint.
Top Skills:
Salesforce
What you need to know about the San Francisco Tech Scene
San Francisco and the surrounding Bay Area attracts more startup funding than any other region in the world. Home to Stanford University and UC Berkeley, leading VC firms and several of the world’s most valuable companies, the Bay Area is the place to go for anyone looking to make it big in the tech industry. That said, San Francisco has a lot to offer beyond technology thanks to a thriving art and music scene, excellent food and a short drive to several of the country’s most beautiful recreational areas.
Key Facts About San Francisco Tech
- Number of Tech Workers: 365,500; 13.9% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Google, Apple, Salesforce, Meta
- Key Industries: Artificial intelligence, cloud computing, fintech, consumer technology, software
- Funding Landscape: $50.5 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Sequoia Capital, Andreessen Horowitz, Bessemer Venture Partners, Greylock Partners, Khosla Ventures, Kleiner Perkins
- Research Centers and Universities: Stanford University; University of California, Berkeley; University of San Francisco; Santa Clara University; Ames Research Center; Center for AI Safety; California Institute for Regenerative Medicine
