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Entrada Therapeutics

Director, Clinical Data Management

RemoteUnited States only· Prefers United Kingdom
Published
Experience
Lead
Employment
Full-time
Company size
Startup
$219k–$244.5k/yr
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Open to US only · Prefers United Kingdom. Set where you work from to check your eligibility.

The listing prefers candidates in United Kingdom.

No BS summary

Strategic and hands-on leader for Clinical Data Management, reporting to Head of Biometrics. Must have 10+ years of experience, including people/CRO management, strong critical thinking, and proficiency in Medidata RAVE. Experience with CDASH, SDTM, and ICH GCP guidelines is required.

Core skills

Clinical Data ManagementData StandardsCRO Management

Required skills

Medidata RAVECDASHSDTMICH GCP

Optional skills

programming experienceCluePointsSpotfireregulatory GCP inspections/audits

Required languages

English

What you'll do

  • 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

What they require

  • 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
  • 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

Benefits

  • 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

Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others.

🇺🇸 United StatesBiopharmaceuticalsStartupentradatx.com
$219k–$244.5k/yr