Senior Manager, Data Management

Role Summary:

We are seeking an analytical and detail-oriented individual, who will serve as the lead clinical data manager for clinical studies as assigned and is responsible for providing input to protocols, leading design and review of case report forms, assisting with development and validation of clinical databases and systems, and performing all data management related activities.  

Key Responsibilities:

• Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival
• Conduct oversight of and provide guidance to data management CROs to ensure that data management documents and tasks are completed and delivered in accordance with timelines and data quality standards
• Oversee and drive development of study related data management deliverables (e.g., eCRF, DTA, etc.)
• Participate in the implementation and UAT of clinical systems (e.g., EDC, IRT, eCOA)
• Coordinate cross functional data review and provide proactive review of data trends and issue resolution
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree is required. 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry, with 5-8 years as a Lead Data Manager.
• Hands-on knowledge and experience in data management activities, such as CRF and EDC design, review, and validation of data from various vendors
• Knowledge of real-time data flow across clinical systems
• Strong knowledge of EDC systems (Medidata Rave, Veeva, or equivalent)
• Knowledge of GCP, ICH, and regulatory requirements
• Successful track record of working independently in a matrixed organization or in a start-up environment and providing effective solutions to emerging problems
• Excellent interpersonal communication skills, along with organizational skills

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $170,000 to $186,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.