Job Description Under the direction of Clinical Data Manager and Global Data Management and Standards (GDMS) leadership, the Executive Director, Clinical Data Manager TA/Indication Lead provides operational leadership for data management delivery within an assigned indication(s) for a therapeutic area. The role oversees day‑to‑day portfolio execution, resource management, and risk and quality oversight to ensure timely, compliant, and high‑quality delivery of study and program data. The Executive Director partners cross‑functionally across Clinical, Biostatistics and Research Data Science (BARDS), Global Data Integration and Automation (GDIA), and Global Clinical Data Standards (GCDS) to ensure consistent standards application, operational excellence, and capability development within the TA. Primary Responsibilities Own day‑to‑day TA delivery, ensuring high‑quality, on‑time study and program outputs across all data modalities and tools (eCRF, labs, biomarkers, eCOA, imaging, EDC, etc.). Act as the primary operational link among TA Leads, Program Leads, and Functional Area Geo Leaders; coordinate readiness for key milestones (First Site Ready, First Patient Enrolled, database lock). Support acquisitions, partnerships, and due diligence activities as requested, ensuring operational continuity and data readiness. Track TA Book of Business and demand. Proactively initiate resourcing at the appropriate time and balance workload and capacity across studies and geographies to meet delivery commitments. Monitor TA performance metrics (data currency, query aging, lock timeliness). Lead TA‑level risk reviews, trigger CAPAs as needed, and ensure effective follow‑through. Drive consistent use of GDMS standards, tools, and processes, ensuring SOP, ICH‑GCP, study protocol and regulatory adherence. Ensure documentation completeness and consistency; support audits and inspections across studies. Represent the TA in relevant governance and oversight forums (TAST, TA DRC). Promote collaboration and continuous improvement across Clinical Data Manager teams, driving alignment, standardization, and shared learning. Support the development and maintenance of TA‑specific onboarding and training to build consistent capability across the TA. Contribute expertise, project management, and/or leadership to additional projects and continuous improvement initiatives, including process, standards, and platform/tool efforts. Set clear objectives aligned to organizational goals; assign work and set priorities. 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. Coach and develop team members, identifying skill gaps and development needs. Lead recruiting and hiring; manage sensitive employee‑relations matters in partnership with HR. Balance workloads to support value‑added work and work‑life sustainability; anticipate obstacles and adjust plans. Coordinate on‑shore/off‑shore and contingent resources; ensure role clarity and effective handoffs. Manage an operating budget and optimize spend against priorities. Align teams around a clear direction; facilitate team/functional meetings. Provide concise, decision‑ready updates and status reporting to leadership and partners. Deep experience leading end‑to‑end clinical data management for trials, including database design/build, UAT, edit checks and validation, data review and reconciliation, and database lock. Extensive experience authoring, validating, and maintaining data management deliverables and validation components to ensure accuracy, auditability, and inspection readiness. Deep understanding of data structures, integrations, and data flow across EDC and connected systems (labs, IRT, eCOA, imaging), with a proven ability to triage and resolve study‑level issues across internal systems and service providers. Extensive knowledge of Clinical Data Manager platforms and enabling technologies, including EDC, query management, reconciliation/integration tools, and data visualization/dashboarding. Advanced Therapeutic Area expertise, applying TA‑specific scientific and operational knowledge to shape data management strategy and decision‑making at the indication and TA level. Comprehensive understanding of the clinical development lifecycle, clinical practice, and medical terminology, with strong awareness of cross‑functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory). Advanced proficiency in CDISC standards (CDASH, SDTM, Define‑XML), metadata management, and controlled terminologies (LOINC). Strong working knowledge of SOPs, ICH‑GCP, 21 CFR Part 11/Annex 11, and privacy expectations, applying risk‑based, data‑driven approaches (RBQM). Non‑Technical Skills Exceptional communication and collaboration skills, enabling effective leadership across cross‑functional and global teams. Ability to lead through influence, align stakeholders, and motivate teams around shared objectives. Strong leadership presence with demonstrated people leadership, mentoring, and coaching capabilities across multiple levels and geographies. Sound judgment and accountability, integrating business, operational, and people considerations to make effective decisions within operational constraints. Strong organizational and prioritization skills, able to manage multiple, competing deliverables while maintaining focus on critical outcomes. Commitment to continuous improvement, fostering a culture of operational excellence, accountability, and high performance. Strong analytical and critical thinking capability, able to operate effectively in ambiguity, synthesize complex information, and develop innovative, compliant solutions to complex data and operational challenges. Enterprise Leadership Skills Networking & Partnerships – Develops and maintains strategic relationships with internal and external stakeholders to bring forward the information, perspectives, expertise, and influence needed to address issues and advance organizational goals. Coaching & Development – Provides feedback, guidance, and development support to help others excel in current and future roles, while actively building the skills and capabilities needed for individual and organizational success of Clinical Data Manager. Influence – Uses thoughtful influence strategies to build alignment, secure stakeholder commitment, and drive actions that advance shared priorities and business goals. Qualifications Advanced Degree (preferred) (Masters or Doctorate） in Nursing, Pharmacy, Life sciences, Allied Health, Data/Information technology or Medical Technology with 8 years of experience in clinical data management, clinical trial operations or related field, including 3 years of people management experience. Demonstrate deep SME skill in relevant discipline. OR Advanced Degree (preferred) (Masters or Doctorate） in Nursing, Pharmacy, Life sciences, Allied Health, Data /Information technology or Medical Technology with 4 years of experience in clinical data management, clinical trial operations or related field. AND Demonstrated experience in leading geo cross‑functional Teams in delivery of clinical data management or clinical trial operations strategy, execution and submissions (Inspections & Health Authority Interactions & Responses). Salary and Benefits Salary range: $231,900.00 – $365,000.00. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, healthcare and other insurance benefits (for employee and family); retirement benefits, including 401(k); paid holidays, vacation, compassionate and sick days. More information about benefits: Equal Employment Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. Job Posting Details Job Posting End Date: 05/27/2026. Requisition ID: R . Employee Status: Regular. Relocation: Domestic/International. VISA Sponsorship: Yes. Travel Requirements: 25%. Flexible Work Arrangements: Hybrid. Shift: Not Indicated. 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