Director, Clinical Data Management - Hybrid

Job Description

Job Description

The Director, Study Integration Manager leads a team and has portfolio-level oversight of study-integration delivery across programs and regions. This Director serves as senior technical authority—approving high-impact designs, governing standards at scale, balancing demand vs. capacity, and driving automation and operational excellence—while remaining close to the work through targeted reviews and coaching. Represents the function in internal/external forums and ensures consistent, audit-ready outcomes.

Responsibilities:

Study technical planning & delivery

• Own the integrated plan from design through closeout across in-scope studies; synchronize releases and dependencies.
• Ensure all technical components are production-ready before first-patient-first-visit; monitor status/quality pre- and post-release.
• Oversee decommissioning and archival with complete, audit-ready documentation.
• Directly lead critical or high-risk studies or cross-program integrations to unblock delivery and model best practices.

• Set the program/TA technical strategy aligned to GDMS/DI&A goals; translate business objectives into executable technical roadmaps and outcomes.
• Participate as needed on the DI&A governance team; present decision-ready recommendations and trade-offs.
• Define and manage SOWs/SLAs/SLOs; track service provider delivery health and hold partners accountable for quality and timelines.
• Champion risk-based computer system validation (CSV) and inspection readiness in partnership with cross-functional teams.
• Coordinate internal audits (point of contact), including evidence, responses, and action plans.
• Communicate status, risks, and decisions to sponsors and governance forums with clear escalation paths.
• Build business cases and prioritize initiatives; define OKRs/KPIs and dashboards (quality, cycle time, cost, stability) and track value realized.

• Act as design authority for data collection/flows, integrations, and validation patterns; arbitrate configure vs. customize decisions.
• Drive design consistency based on global and TA standards in all key deliverables part of clinical data management system.
• Provide technical consultancy on data architecture, metadata, and cross-system interoperability
• Mentor and coach junior team members; review plans/specs, uplift practices (agile, testing, automation), and create learning opportunities.
• Foster experiment/test-and-learn culture; sponsor communities of practice and reusable assets/templates.
• Lead strategic improvement initiatives (automation, CI/CD in validated contexts, test efficiency, MDR/metadata enablement), including introduction of new processes / technologies

• Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
• Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
• Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
• Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
• Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
• Manage an operating budget and optimize spend against priorities.
• Inspire and ensure that team leaders are effectively supporting and empowering their individual leaders.

• Demonstrated ability to review and approve complex designs and integration patterns; optimize mappings, error handling, and data lineage.
• Deep knowledge of data capture,…