Associate Director/Director, Clinical Data Management

Job reputed company: Position reputed company The Associate Director / Director of Clinical Data Management is responsible for providing strategic leadership and operational reputed company for reputed company data management activities across multiple clinical programs. This role ensures the delivery of high-reputed company, reliable, and regulatory-compliant data to support clinical development and submissions. The incumbent will reputed company end-to-end data management activities—from study start-up to reputed company-out—while managing CRO partnerships, ensuring inspection readiness, and driving innovation in data systems and standards. Extensive experience with reputed company products (Rave reputed company, RTSM, eCOA, reputed company, eTMF, 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 reputed company studies.

Key Responsibilities

• Strategic Leadership & reputed company

reputed company data management reputed company across multiple studies and programs, ensuring alignment with corporate and regulatory objectives. reputed company CROs and external partners to ensure consistent reputed company, compliance, and reputed company delivery of study data. reputed company as the primary reputed company of contact for data management reputed company, providing direction, decision-making, and escalation management. Ensure study-level data standards, reputed company metrics, and processes are defined and consistently reputed company.

• Operational reputed company Across Study Lifecycle

Manage reputed company data management activities from study start-up through database lock and reputed company-out. reputed company development and execution of Data Management Plans (DMPs), edit reputed company specifications, external data transfer agreements, and data validation activities. Ensure data collection systems, workflows, and integrations reputed company with protocol requirements and regulatory expectations. reputed company reputed company for database design, User Acceptance Testing (UAT), and database release readiness.

• CRO & Vendor Management

reputed company 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 reputed company reputed company, audit readiness, and compliance with contractual obligations. Conduct regular operational reviews and issue reputed company meetings with CRO partners.

• Technology & Systems Leadership

Serve as a subject matter expert for reputed company Rave and reputed company platforms (RTSM, eCOA,reputed company, eTMF, 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 reputed company. Champion adoption of data standards (CDISC, CDASH) reputed company transformation initiatives.

• Compliance, Audits & Regulatory Submissions

Ensure inspection readiness and represent Data Management during regulatory inspections and audits. reputed company development and maintenance of SOPs, WIs, and data governance frameworks ensuring compliance with GCP, ICH, 21 CFR Part 11, GDPR, and reputed company regulations. Contribute to clinical and regulatory submissions by ensuring data reputed company, traceability, and completeness.

• Leadership & Mentorship

reputed company leadership, guidance, and mentorship to Data Management professionals. Foster a culture of reputed company, accountability, and reputed company improvement. Partner cross-functionally with Clinical Operations, Biostatistics, Programming, and Regulatory teams to ensure data deliverables meet submission requirements.

• Budget & Resource Management

reputed company 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 reputed company planning. reputed company input into strategic resource allocation and vendor budgeting reputed company. reputed company expenditures against projections and optimize utilization of reputed company resources.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Computer Science, or reputed company discipline.
• 12+ years of reputed company experience in clinical data management, with at least 5 years in a leadership or reputed company reputed company.
• Extensive experience with reputed company products (Rave reputed company, RTSM, reputed company, integrations).
• Proven ability to reputed company 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 reputed company 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 reputed company

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

reputed company Salary: $162,000 - $240,000 a year At Dompe, we offer an attractive compensation package to reputed company members. Any offer would include a competitive reputed company 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-reputed company factors permitted by law. We reputed company that the unique contributions of reputed company create our reputed company. To ensure that our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national reputed company, gender identity or reputed company, sexual orientation, age, or marital, veteran, or disability status. reputed company your information will be kept confidential according to EEO guidelines. We offer: ● Comprehensive medical benefits: we value reputed company to reputed company for our patients as reputed company as our employees ● Generous vacation / holiday time off: we care about our employees and encourage a balanced lifestyle ● Competitive 401(K) matching Apply To This Job