Associate Director, Data Management

Role Summary:

We are seeking 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 in design and review case report forms, assisting 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 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 proactively review of data trends and issue resolution

Ideal Candidate:

• Bachelor’s degree is required
• 10+ years of data management experience in the pharmaceutical, biotech, or CRO industry
• Hand-on knowledge and experience in data management activities, such as CRF and EDC design, review, and validation from various vendors
• Knowledge of real-time data flow across clinical systems
• Knowledge of SDTM and experience in transforming raw data into these standards
• Knowledge of GCP, ICH, and regulatory requirements
• Successful track record of working independently in a matrixed organization or in a start-up environment 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 $195,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.