4D Molecular Therapeutics
Powering the Future of Genetic Medicines
Senior Manager, Data Management
Location
United States
Posted
33 days ago
Salary
$178K - $208K / year
Bachelor Degree7 yrs expEnglishGoogle Cloud Platform
Job Description
• Manage end‑to‑end Data Management activities for one or more clinical studies with moderate guidance from line manager.
• Oversee daily study‑level data management operations, ensuring compliance to timelines, quality standards, and SOPs.
• Support vendor oversight activities, including reviewing timelines, deliverables, and quality metrics.
• Contribute to risk identification and mitigation strategies for data‑related issues.
• Review study protocols to ensure appropriate data capture elements and eCRF design.
• Support the development of eCRF specifications and contribute to review of data requirements.
• Assist in coordinating EDC system design, testing, and UAT, ensuring adherence to company standards.
• Contribute and/or author Data Management Plans, Data Transfer Plans, and other study‑related documents.
• Support review of clinical monitoring plans, SAPs, and vendor specifications.
• Monitor data quality and cleaning activities, including management of data listings and reconciliation efforts.
• Partner with CROs and external vendors to ensure timely and high‑quality data deliverables.
• Participate in study team meetings, providing updates on Data Management metrics and timelines.
• Escalate issues appropriately to line manager, data management leadership or other functional leads.
• Oversee reconciliation activities (e.g., header data, SAE reconciliation) performed by CROs.
• Support database upgrades and migrations, including contribution to UAT.
• Participate in database snapshot, lock, and freeze activities.
• Provide day‑to‑day guidance and mentorship to Data Managers.
• Deliver training to internal and external team members on EDC systems or eCRF completion guidelines as needed.
• Maintain Data Management documentation and eTMF files.
• Other duties assigned.
Job Requirements
- B.A./B.S. degree or higher (life-science-related fields preferred) or equivalent experience.
- 7+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers of which at least three (3+) years in a lead study data manager role.
- Experience with Phase 1-3 clinical trials required: retina diseases and/or gene therapies experience a plus.
- Demonstrated experience in vendor oversight and cross‑functional team leadership.
- In-depth knowledge and experience with CDISC data standards and models.
- Proficient in using clinical data management systems (e.g., Medidata Rave) and the data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.)
- Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials.
- Knowledge of ICH GCP and other applicable regulatory rules and guidelines.
- Knowledge of the clinical development process.
- Proficient with MS Office (Word, Excel, PowerPoint, etc.)
- Strong communication and interpersonal skills (written and verbal).
- High attention to detail with excellent organizational and time‑management capabilities.
- Ability to manage multiple projects in a fast-paced environment.
- Proven conceptual, analytical and strategic thinking.
- Excellent attention to details.
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
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