Note: The job is a remote job and is open to candidates in USA. Entrada Therapeutics is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases. The Director, Clinical Data Management will lead clinical data management across multiple drug development programs, establish data standards, oversee internal staff and CRO partners, and ensure data quality, compliance, and delivery against clinical study milestones.
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
Skills
- 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
- 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
- Experience with regulatory GCP inspections/audits preferred
Benefits
- US based remote position
- Comprehensive health, dental and vision coverage
- Life and disability insurance
- 401(k) match
- Paid, gender-inclusive parental leave
- Holistic support for your health and well-being
- Education reimbursement
- Discretionary time off
- Commuting benefits aligned to your working model
Company Overview
Company H1B Sponsorship