Senior Manager, Data Management

Role Overview

• 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.

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off
• Professional development opportunities