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Senior Director, Data Management (Boston)
Senior Director, Data Management (Boston)Canopy Life Sciences • Boston, MA, US
Senior Director, Data Management (Boston)

Senior Director, Data Management (Boston)

Canopy Life Sciences • Boston, MA, US
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Canopy Life Sciences is a well-respected vendor & partner in the life sciences industry, assisting pharmaceutical and life sciences clients in various functional areas of expertise. Our culture is one of empowerment. Everyone has a voice and plays a role in the success of the business and a role in developing our values & behaviors. We recruit, train, and develop people to ensure the very best for our client partners.

Job Title : Head of Clinical Data Management

Location : [Insert Location]

Department : Clinical Development

Location : Boston, MA

Position Overview

The Head of Clinical Data Management is a senior leadership role responsible for overseeing end-to-end data management activities across a global oncology clinical portfolio. This individual will define data strategy, lead data management operations, and ensure the integrity, quality, and regulatory compliance of all clinical trial data from study start-up through database lock and submission.

Key Responsibilities

Strategic Leadership

  • Develop and implement a scalable data management strategy aligned with clinical and regulatory objectives.
  • Lead and mentor a high-performing data management team and foster a culture of quality and accountability.
  • Drive the evaluation and adoption of innovative data technologies and systems (e.g., EDC, ePRO, eSource).
  • Establish and maintain standard operating procedures (SOPs), data standards, and best practices.

Operational Execution

  • Oversee the full lifecycle of clinical data management deliverables across multiple oncology studies.
  • Direct database design, CRF development, data validation, query resolution, and database lock procedures.
  • Lead the selection, management, and oversight of CROs and external data vendors.
  • Ensure data accuracy, consistency, and readiness for interim analyses and regulatory submissions.

    • Quality & Compliance

  • Ensure compliance with GCP, CDISC standards, 21 CFR Part 11, and global regulatory expectations.
  • Oversee data cleaning strategies, medical coding (MedDRA, WHODrug), and quality control processes.
  • Maintain audit-ready documentation and support regulatory inspections and submission activities.

    • Cross-Functional Collaboration

  • Serve as the primary data management partner to Clinical Operations, Biostatistics, Safety, and Regulatory teams.
  • Support clinical trial planning, protocol review, and data strategy for complex oncology trials including biomarkers and translational endpoints.

    • Qualifications

    Required

  • Extensive experience in clinical data management within pharmaceutical or biotechnology organizations.
  • Strong background in oncology clinical trials across multiple phases.
  • Proven leadership experience managing data management teams and external partners.
  • Expertise with EDC platforms (e.g., Medidata Rave, Veeva) and clinical data standards (CDISC).
  • Demonstrated experience with regulatory submissions (NDA, BLA, or equivalent).
  • Strong understanding of global data compliance and quality standards.
  • Excellent leadership, problem-solving, and project management skills.

    • Compensation - DOE

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    Director Data Management • Boston, MA, US