Director, Clinical Data Management Indication Lead, Late Oncology

Director, Clinical Data Management Indication Lead, Late Oncology

Responsibilities
- Own day-to-day therapeutic area delivery, ensuring high-quality, on-time outputs across data modalities/tools (eCRF, labs, biomarkers, eCOA, imaging, EDC).
- Primary operational link among TA Leads, Program Leads, and Functional Area Geo Leaders; coordinate readiness for milestones (First Site Ready, First Patient Enrolled, database lock).
- Support acquisitions/partnerships/due diligence for operational continuity and data readiness.
- Track TA Book of Business and demand; proactively initiate resourcing and balance workload/capacity across studies and geographies.
- Monitor performance metrics (data currency, query aging, lock timeliness); lead TA risk reviews, trigger CAPAs, and ensure follow-through.
- Drive consistent use of GDMS standards/tools/processes; ensure SOP, ICH-GCP, protocol, and regulatory adherence.
- Ensure documentation completeness/consistency; support audits and inspections.
- Represent TA in governance forums (e.g., TAST, TA DRC).
- Promote collaboration/continuous improvement across Clinical Data Management teams; support onboarding/training.
- Set objectives, assign work/priorities, run check-ins/annual reviews, coach/develop team members, support recruiting/hiring, manage employee-relations with HR, balance onshore/offshore resources, manage operating budget.
- Provide decision-ready updates/status to leadership.

Technical Skills
- End-to-end clinical data management leadership (database design/build, UAT, edit checks/validation, reconciliation, database lock).
- Author/validate/maintain data management deliverables for audit/inspection readiness.
- Deep understanding of data structures/integrations/data flow across EDC and connected systems; triage and resolve issues.
- Knowledge of Clinical Data Manager platforms (EDC, query management, reconciliation/integration tools, data visualization).
- CDISC (CDASH, SDTM, Define-XML), metadata management, controlled terminologies (e.g., LOINC).
- Knowledge of SOPs, ICH-GCP, 21 CFR Part 11/Annex 11, privacy; apply RBQM.

Non-technical Skills
- Communication/collaboration across cross-functional, global teams; lead through influence.
- People leadership/mentoring/coaching; sound judgment/accountability.
- Strong organization/prioritization; continuous improvement mindset; analytical/critical thinking in ambiguity.

Qualifications
- Bachelor’s in Nursing/Pharmacy/Life Sciences/Allied Health/Data-IT/Medical Technology (or equivalent) +10 years clinical data management or clinical trial ops (incl. 3 years people management) OR
- Bachelor’s in any field +15 years (incl. 3 years people management) OR
- Preferred advanced degree +8 years (incl. 3 years people management) OR
- Preferred advanced degree (any field) +13 years (incl. 3 years people management).
- Demonstrated experience leading geo-different cross-functional teams delivering clinical data management/clinical trial ops strategy, execution, and submissions (inspections and Health Authority interactions/responses).

Required Skills
- Change management; Clinical data standards; Clinical trials operations; Cross-functional teamwork; Data governance; Decision making; Ethical standards; GCP; Oncology; People leadership; Stakeholder relationship management; Strategic planning.

Preferred Skills
- Adaptability; Operational execution; Strategic thinking.

Application Instructions
- Apply via https://jobs.merck.com/us/en (deadline as stated on the posting).