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

Requirements

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.

Benefits

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementeCRF designEDC designdata validationdata reviewissue resolutionreal-time data flow

Soft Skills

interpersonal communicationorganizational skillsproblem-solving

Certifications

Bachelor's degree