4 дня назад
Director, Clinical Data Management (Biotech)
219 000 - 244 500$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, Clinical Data Management (Biotech): Leading clinical data management strategy, systems, standards, and deliverables across multiple drug development programs with an accent on data quality, CDASH/SDTM/ADaM compliance, and CRO oversight. Focus on designing clinical data systems, applying AI and automation, managing inspection readiness, and delivering reliable data for analysis and regulatory submissions.
Location: US-based remote position with required minimum monthly or quarterly travel to the headquarters in Boston, Massachusetts; preference for New England-based candidates.
Salary: $219,000–$244,500 per year
Company
is a clinical-stage biopharmaceutical company developing genetic medicines for neuromuscular and inherited retinal diseases, including Duchenne muscular dystrophy and myotonic dystrophy type 1 programs.
What you will do
- Lead clinical data management strategy and deliverables across multiple drug development programs.
- Develop and oversee data management plans, database designs, edit check specifications, and CRF completion guidelines.
- Manage, mentor, and develop internal data management staff while overseeing CRO data management personnel.
- Establish systems and processes that protect clinical data security, integrity, quality, and delivery timelines.
- Lead CRO and vendor selection, contracting input, oversight, performance management, and budget management.
- Represent clinical data management on cross-functional teams, regulatory inspections, audits, and senior leadership discussions.
Requirements
- BS in computer science or a science-based discipline; an advanced degree is a plus.
- 10+ years of industry clinical data management experience, including several years managing people or CRO data management teams.
- Strong CRO vendor oversight, budget management, critical thinking, risk mitigation, and communication skills.
- Proficiency with Medidata RAVE and other EDC platforms; experience with CluePoints, Spotfire, or similar data review tools.
- Experience designing clinical trials using CDASH and SDTM terminology, with a strong understanding of FDA and ICH GCP guidelines.
- Must be based in the United States; the role requires recurring travel to the Boston headquarters.
Nice to have
- Programming experience.
- Experience with regulatory GCP inspections and audits.
Culture & Benefits
- Collaborative, fast-paced, and innovative environment focused on developing therapies for patients.
- Health, dental, and vision coverage, life and disability insurance, and a 401(k) match.
- Paid gender-inclusive parental leave and health and well-being support.
- Education reimbursement, discretionary time off, and commuting benefits aligned to the working model.
- Equal opportunity employment with support for a diverse workforce.
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