Senior Manager, Data Management

Role Summary

The Senior Manager, Data Management leads end-to-end clinical data management activities for assigned studies and provides operational oversight to internal staff and external vendors. This role is a key member of cross-functional study teams, contributing to planning, execution, and delivery of high-quality clinical trial data across all phases. The Senior Manager possesses robust working knowledge of clinical data management processes and independently executes most tasks while guiding other Data Managers and vendor partners.

• 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: nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• 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.
• Experience in vendor management and performance assessments.
• 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 processes 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).
• Collaborative mindset with ability to work effectively.
• 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.

• B.A./B.S. degree or higher (life-science-related fields preferred) or equivalent experience.

• Travel: 0-10%, based on study needs.
• Physical Activity:
  Repetitive motions of the wrists, hands, and/or fingers; typing or other fine motor tasks; talking.
• Physical Requirements:
  
  Sedentary work; may exert up to 10 pounds of force occasionally; mostly sitting.
• Working Conditions:
  
  Not substantially exposed to adverse environmental conditions.