Associate Director/Director, Clinical Data Management

Associate Director/Director, Clinical Data Management Dompè - 3.7 San Mateo, CA Job Details $162,000 - $240,000 a year 22 hours ago Benefits Health insurance 401(k) matching Qualifications FDA submissions Stakeholder engagement Procedural guides Managing data teams Technology management CDISC standards Managing clinical research teams Forecasting Technology budget management Clinical trial standard operating procedures Regulatory submissions Budget management in healthcare Clinical quality assurance standards Project leadership Standard operating procedures (SOPs) Program budgeting Stakeholder relationship building Senior leadership Stakeholder management Full Job Description Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand-in-hand with a commitment to research and development to meet unsatisfied therapeutic needs. Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L'Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R D) and in the San Francisco Bay Area (Commercial Operations). Position Summary The Associate Director / Director of Clinical Data Management is responsible for providing strategic leadership and operational oversight for all data management activities across multiple clinical programs. This role ensures the delivery of high-quality, reliable, and regulatory-compliant data to support clinical development and submissions. The incumbent will oversee end-to-end data management activities—from study start-up to close-out—while managing CRO partnerships, ensuring inspection readiness, and driving innovation in data systems and standards. Extensive experience with Medidata products (Rave EDC, RTSM, eCOA, Coder, e

TMF, RIM

integrations, etc.), data governance, and global regulatory compliance is essential. The individual will play a key role in shaping and implementing SOPs, Work Instructions (WIs), and technology strategies that enhance efficiency and compliance across all studies. Key Responsibilities Strategic Leadership & Oversight Lead data management strategy across multiple studies and programs, ensuring alignment with corporate and regulatory objectives. Oversee CROs and external partners to ensure consistent quality, compliance, and timely delivery of study data. Act as the primary point of contact for data management oversight, providing direction, decision-making, and escalation management. Ensure study-level data standards, quality metrics, and processes are defined and consistently applied. Operational Excellence Across Study Lifecycle Manage all data management activities from study start-up through database lock and close-out. Oversee development and execution of Data Management Plans (DMPs), edit check specifications, external data transfer agreements, and data validation activities. Ensure data collection systems, workflows, and integrations align with protocol requirements and regulatory expectations. Provide oversight for database design, User Acceptance Testing (UAT), and database release readiness. CRO & Vendor Management Lead governance and performance management of CROs supporting data management functions. Review and approve study deliverables (CRFs, DMPs, edit checks, transfer specs, listings, and reconciliation plans). Ensure quality oversight, audit readiness, and compliance with contractual obligations. Conduct regular operational reviews and issue resolution meetings with CRO partners. Technology & Systems Leadership Serve as a subject matter expert for Medidata Rave and related platforms (RTSM, eCOA,Coder, e

TMF, RIM

). Drive implementation and optimization of Data Management Technologies and data integration solutions. Collaborate with IT and Biometrics teams to standardize and enhance system interoperability and data flow. Champion adoption of data standards (CDISC, CDASH) and digital transformation initiatives. Compliance, Audits & Regulatory Submissions Ensure inspection readiness and represent Data Management during regulatory inspections and audits. Oversee development and maintenance of SOPs, WIs, and data governance frameworks ensuring compliance with

GCP, ICH, 21 CFR

Part 11, GDPR, and related regulations. Contribute to clinical and regulatory submissions by ensuring data integrity, traceability, and completeness. Leadership & Mentorship Provide leadership, guidance, and mentorship to Data Management professionals. Foster a culture of quality, accountability, and continuous improvement. Partner cross-functionally with Clinical Operations, Biostatistics, Programming, and Regulatory teams to ensure data deliverables meet submission requirements. Budget & Resource Management Develop and manage budgets for data management operations, ensuring cost efficiency and alignment with departmental goals. Forecast resource requirements across ongoing and upcoming studies, ensuring appropriate capacity planning. Provide input into strategic resource allocation and vendor budgeting decisions. Track expenditures against projections and optimize utilization of internal and external resources. Qualifications Bachelor's or Master's degree in Life Sciences, Computer Science, or related discipline. 12+ years of progressive experience in clinical data management, with at least 5 years in a leadership or oversight capacity. Extensive experience with Medidata products (Rave EDC, RTSM, Coder, integrations). Proven ability to oversee multiple global studies and CROs concurrently. Deep understanding of clinical data management processes, data standards (CDASH, CDISC), and technology landscape. Experience in authoring and implementing SOPs, WIs, and operational best practices. Demonstrated success in supporting regulatory submissions (NDA, BLA, MAA) and managing inspection readiness. Strong leadership, problem-solving, and decision-making skills with the ability to operate independently. Excellent communication, organizational, and stakeholder management skills. Experience with budget forecasting, cost tracking, and resource planning for multi-study portfolios.

BENEFITS OF JOINING OUR TEAM

Comprehensive medical benefits: we value access to healthcare for our patients as well as our employees Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle Competitive 401(K) matching

Base Salary:

$162,000 - $240,000 a year At Dompe, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. We believe that the unique contributions of all employees create our success. To ensure that our products and culture continue to incorporate everyone's perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines.