Director, Clinical Data Management

Entrada Therapeutics•Boston, MA

1d•Remote

About The Position

Entrada Therapeutics is a clinical-stage biopharmaceutical company focused on developing a new class of medicines for intracellular targets. The company has a robust portfolio of genetic medicines for neuromuscular and inherited retinal diseases, including partnerships with Vertex Pharmaceuticals. Entrada is entering a catalyst-rich period with multiple clinical data readouts expected by the end of 2026. They are seeking a strategic and hands-on leader to join their high-energy, dedicated team and contribute to their mission of dramatically improving patient lives.

Requirements

BS in computer science, or a science-based subject (advanced degree a plus)
10+ years of clinical data management experience in industry
Several years directly managing people and/or CRO data management teams
Strong critical thinking and sound judgment, with a consistent record of turning problems into concrete, actionable plans
Strong CRO vendor management, oversight, and budget management experience
Proficient in Medidata RAVE and other EDC platforms; programming experience is a plus
Experience with CluePoints, Spotfire or similar data review/analytics tools
Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
Strong understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
Experience with regulatory GCP inspections/audits preferred
Exceptional written and verbal communication skills, with demonstrated success communicating clearly and credibly with senior leadership, cross-functional partners, CRO/vendor partners, and regulators
Desire to work in a collaborative, fast-paced, and innovative environment

Nice To Haves

Advanced degree a plus
Programming experience is a plus
Experience with regulatory GCP inspections/audits preferred

Responsibilities

Provide expertise and contribute to the strategy and development of the Clinical Data Management Systems to ensure data quality in support of clinical study data milestones and deliverables
Directly manage, mentor, and develop internal DM staff, and provide day-to-day oversight and leadership of data management personnel at CRO partners, holding both internal staff and vendors accountable to quality and timeline commitments
Lead and support establishment of systems and processes to help ensure clinical data security and integrity.
Own end-to-end DM deliverables across the program portfolio.
Develop and oversee the Data Management Plan, database design, edit check specifications, and CRF completion guidelines, ensuring adherence to CDASH, SDTM, and ADaM standards, and quality and consistency across studies.
Stay current on emerging technologies and industry best practices in clinical data management, and proactively evaluate opportunities to apply AI and automation to improve data quality, efficiency, and speed to database lock
Drive standardization and continuous process improvement initiatives through to completion, with defined action plans, milestones, and measurable outcomes
Serve as the primary point of contact for DM matters for the Head of Biometrics and cross-functional leadership internally, and with CRO/vendor partners, auditors, and regulatory agencies externally
Lead CRO/vendor selection, contracting input, ongoing oversight, and performance/budget management for outsourced data management activities
Own inspection and audit readiness for Clinical Data Management, and represent DM directly during regulatory inspections and audits
Proactively identify data quality, timeline, and vendor-performance risks; bring forward clear, actionable mitigation plans rather than open-ended concerns
Represent DM on cross-functional project and submission teams, and communicate DM strategy, status, and risks clearly and concisely to senior leadership