Director Data Management

Job Title: Director of Clinical Data Management
Location: Cambridge, MA (Hybrid)
Employment Type: Full-Time

About the Role:
We are seeking a highly experienced and detail-oriented Director of Clinical Data Management to lead data strategy and execution across oncology clinical trials. This role is pivotal in ensuring the integrity, quality, and timely delivery of clinical data from early-phase studies through to database lock.

Key Responsibilities:

• Oversee the design, implementation, and maintenance of electronic data capture (EDC) systems, including edit checks and data listings.
• Lead data cleaning activities, discrepancy management, and reconciliation of external data sources (e.g., PK, IVRS, central lab, imaging).
• Collaborate with clinical operations, quality assurance, and external vendors to ensure data accuracy and compliance.
• Manage protocol deviation reviews and data transfer processes.
• Develop and maintain data specification documents and ensure adherence to regulatory and internal standards.
• Provide oversight of CROs and ensure alignment with project timelines and deliverables.

Qualifications:

• Bachelor's or advanced degree in life sciences, computer science, or a related field.
• Minimum of 2 years of industry experience in clinical data management, preferably in oncology.
• Proficiency with Medidata RAVE and familiarity with RECIST 1.1 and MedDRA coding.
• Basic SAS programming skills are a plus.
• Strong initiative, attention to detail, and ability to thrive in a fast-paced, evolving environment.

What We Offer:

• A collaborative and mission-driven environment focused on advancing cancer therapies.
• Opportunities to work on cutting-edge clinical programs with a passionate and experienced team.
• Competitive compensation and benefits.