Senior Manager​/Associate Director, Clinical Data Management

Responsibilities

• Manage all clinical data management aspects from start‑up and database design through close‑out and archival of studies
• Act as lead Clinical Data Manager on one or multiple clinical trials
• Oversee all activities outsourced to clinical research organizations, including review and approval of key deliverables (e.g., Data Management Plan, edit check specifications, CRF Completion Guidelines)
• Act as primary point of contact for both internal and external cross‑functional teams
• Provide subject matter expertise to eCRF design, build, testing, and validation
• Lead data cleaning activities with support from the cross‑functional team
• Responsible for delivery of quality data to support study decisions, abstracts, posters, and presentations
• Oversee eCRF metrics to monitor protocol data collection compliance

• Bachelor’s degree in a scientific or health‑related field preferred
• 6+ years of clinical data management experience within biotech/pharma/CRO environments; leading Phase I‑III global clinical trials, preferably in a clinical‑stage biotechnology company managing outsourced clinical trials
• Experience in oncology preferred
• Experience with Medidata EDC preferred
• Strong understanding of FDA, ICH, and GCP guidelines
• Understanding of clinical database design utilizing SDTM standard terminology
• Familiarity with data visualization tools to support data review
• Ability to lead data management responsibilities within a fast‑paced cross‑functional team
• Experience in oversight of CRO data management responsibilities
• Proficiency in handling multiple data transfers internally and externally
• This role may require up to 5% travel

• Opportunity to join a mission‑driven team where you’ll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
• Competitive compensation, including base salary, performance bonus, and equity
• 100% employer‑paid benefits package
• Flexible PTO; also, two, one‑week company‑wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities

The salary range for this position is $X to $X. The final salary offered will depend on several factors, which may include, but are not limited to relevant years of experience, educational background, and geography.

• Medical, dental, vision, life insurance, short‑ and long‑term disability
• 401(k) savings plan and eligibility for the Company’s long‑term incentive program
• Unlimited PTO; 10 days per calendar year of sick time; holiday pay; two company shutdowns; parental leave 16 weeks; FMLA;
  Military Leave