Provide strategic leadership and oversight of data management activities across clinical studies and programs.
Serve as the functional lead for clinical data management, ensuring alignment with data management processes, development timelines and corporate objectives.
Oversee the design, review, and approval of case report forms (CRFs) and related data collection tools.
Guide clinical database and systems (e.g., EDC, IRT, eCOA, external data integrations) development, validation, UAT, and lifecycle management.
Ensure execution of data management activities across study start-up, study conduct, database lock, and documentation archival.
Oversee Data Management CROs and vendors, ensuring deliverables meet quality standards and timelines.
Oversee and drive development and approval of key study-level data management deliverables (e.g., Data Transfer Agreements, Data Management Plans, edit check specifications, eCRFs).
Lead cross-functional data review activities and proactively identify data trends, risks, and mitigation strategies.
Ensure compliance with GCP, ICH guidelines, CDISC standards, and applicable regulatory requirements.
Support regulatory submissions and inspection readiness activities.
Mentor and develop internal data management staff as the function scales.
Other duties as assigned.

Requirements

Bachelor’s degree is required with 12-15+ years of data management experience in the pharmaceutical, biotech, or CRO industry.
Demonstrated leadership experience overseeing studies and/or managing CRO/vendor partnerships.
Experience building or scaling data management processes in a growing organization is preferred.
Extensive hand-on knowledge and experience in data management activities, CRF and EDC design, review, and validation, and external data transfer and reconciliation.
Working knowledge of CDISC standards (SDTM) and experience supporting data transformation for regulatory submissions.
Deep understanding of GCP, ICH, and global regulatory requirements.
Excellent interpersonal communication skills, along with organizational skills.
Proven ability to operate independently and lead effectively within a matrixed organization.
Strong strategic thinking and problem-solving capabilities.
Experienced people manager with effective delegation skills.
Excellent communication, leadership, and 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 managementcase report forms (CRFs)electronic data capture (EDC)interactive response technology (IRT)electronic clinical outcome assessment (eCOA)data transfer agreementsdata management plansedit check specificationsdata transformationregulatory submissions

Soft Skills

leadershipinterpersonal communicationorganizational skillsstrategic thinkingproblem-solvingmentoringdelegationindependent operationcross-functional collaborationrisk identification