Canopy Life Sciences is hiring: Senior Director, Data Management in Boston

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