Development and execution of data quality strategies, risk-based data review plans, and cross-study harmonization.
Direct the design, testing, validation, and maintenance of clinical databases and electronic data capture (EDC) systems.
Ensure consistent application of CDM standards, tools (e.g., CDISC, Medidata Rave), and procedures.
Oversee issues resolution and data integrity across outsourced vendors and internal teams.
Provide proactive input into clinical protocol design to ensure data collection strategies align with scientific and regulatory requirements.
Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives; cross-project consistency and standardization of case report forms.
Partner with internal stakeholders to align timelines and data delivery requirements.
Participate in cross-functional study teams; influence protocol design, study setup, and data strategy from study start to submission.
Actively support submission readiness, including data integration and final deliverables for regulatory filings.
Participate in protocol development, clinical study reports (CSR), and submission activities.
Manage relationships with CROs and third-party vendors, ensuring alignment with contractual deliverables and performance expectations.
Establish standards and oversight processes for EDC setup, CRF development, data validation, discrepancy management, and database lock.
Drive consistency and scalability through implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs.
Development and improvement of clinical data management processes and tools.
Participates in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning.

Requirements

Bachelor’s degree in related scientific discipline; advanced degree preferred.
10+ years of progressive experience in clinical data management for Director level, 8+ years of progressive experience in clinical data management for Director level, with significant leadership responsibility at a biotech/pharma organization.
Expert knowledge of clinical data management.
Deep expertise in industry standards including CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements.
Proven success leading large-scale global studies, vendor oversight and working in both in-house and outsourced models.
Expertise knowledge and hands on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks required.

Benefits

Competitive Compensation & Benefits package including incentive bonus, equity compensation, matching 401(k), medical, dental, vision, commuter, and fertility benefits.
Generous Paid Holidays and Unlimited PTO.
Flexible working hours/schedule.

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical data managementdata quality strategiesrisk-based data reviewdata validationdata integrityprotocol designstatistical analysis plansdata integrationdiscrepancy managementdatabase lock

Soft Skills

leadershipcollaborationinfluencecommunicationproblem-solvingstrategic planningrelationship managementorganizational skillsproactive inputcross-functional teamwork