Director, Clinical Data Management

Entrada Therapeutics•Boston, MA

1d•$219,000 - $244,500•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, with lead oligonucleotide programs for Duchenne muscular dystrophy (DMD) and a collaboration with Vertex Pharmaceuticals for myotonic dystrophy type 1 (DM1). Entrada is entering a catalyst-rich period with multiple clinical data readouts expected by 2026. The company is seeking to grow its team with dedicated individuals who are passionate about improving patient lives and thrive in a high-energy, results-oriented environment.

Requirements

BS in computer science, or a science-based subject (advanced degree a plus), with 10+ years of clinical data management experience in industry, including 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.