4D Molecular Therapeutics

Compensation

Full Description

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. 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