Senior Manager/Associate Director, Clinical Data Management
About The Position
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.
Requirements
- 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
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
Benefits
- Competitive compensation, including base salary, performance bonus, and equity
- 100% employer-paid benefits package
- Flexible PTO
- two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities
- medical, dental, vision, life insurance, short- and long-term disability
- savings plan (401(k))
- long-term incentive program
- Vacation – Unlimited PTO
- Sick time – 10 days per calendar year
- Holiday pay, including two Company shut downs
- Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child
- FMLA
- Military Leave
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What This Job Offers
Job Type
Full-time
Career Level
Senior
