Canopy Life Sciences
Senior Director, Data Management (Boston)
Canopy Life Sciences, Boston, Massachusetts, United States, 02298
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
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