Set the vision, direction, and strategy for Data Management (DM) across clinical development portfolio
Oversee the planning, execution and quality assurance of clinical data management activities
Collaborate within the function and cross-functionally to resolve data management issues
Proactively identify and manage risks for the DM function
Serve as internal DM expert for outsourcing strategy
Ensure data quality/integrity and regulatory compliance for DM processes
Drive SAP and programming timelines to meet deliverables
Represent function in external professional initiatives to identify best practices

Requirements

Advanced degree (MS/PhD) in Life Sciences, Statistics, Computer Science, or related field, or BS with equivalent experience
Minimum 12 years of clinical data management experience in pharmaceutical/biotech industry, including 6+ years of leadership experience managing clinical data management teams and/or vendors
Advanced knowledge and experience working on Global clinical trials (Phase I-IV) and diverse and relevant regulatory requirements within the biopharmaceutical industry across multiple therapeutic areas, including multiple myeloma, lymphoma, CAR-T Therapy
Deep expertise with EDC systems (Medidata Rave preferred) and clinical data standards (CDISC/SDTM/ADaM)
Strong knowledge of GCP, 21 CFR Part 11, and global regulatory requirements
Experience designing, standardizing and implementing data management strategies and standards for global development programs is required
Experience in the management/oversight of CROs and other third-party vendors performing monitoring and DM activities is required
Experience with all aspects of clinical trial conduct (startup through close-out) is required
Prior demonstrated experience serving as a key leader to support organizational decision making and strategic planning required
Understanding of drug development and program management from pre-IND through regulatory filing
Demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
Experience in regulatory filings (e.g., IND, CTA, BLA) highly desired
Previous involvement in the oversight and management of GCP regulatory inspections desired
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
Advanced skills in continuous improvement, project management, change management, and risk management.

Benefits

Flexible Time Off
Health insurance
Commuter benefits
Free parking
State-of-the-art gym
Food hall

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical data managementdata management strategiesEDC systemsCDISCSDTMADaMGCP21 CFR Part 11regulatory complianceclinical trial conduct

Soft Skills

leadershipproblem solvingorganizational skillscommunication skillsstrategic planningrisk managementproject managementchange managementcollaborationinnovation