Dir., Indication Lead, GDMS Clinical Data Mgmt (China Local studies)

Job Description

Under the direction of Clinical Data Management and GDMS leadership the Director Indication Lead GDMs CDM 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 Director partners cross-functionally across Clinical BARDS (Biostatistics and Research Data Science) GDIA (Global Data Integration and Automation) and GCDS (Global Clinical Data Standards) to ensure consistent standards application operational excellence and capability development within the TA.

Responsibilities

Own day-to-day TA (Therapeutic Area) delivery ensuring high-quality on-time study and program outputs across all data modalities and tools (eCRF electronic Case Report Form labs biomarkers eCOA electronic Clinical Outcome Assessment imaging EDC etc.).

Act as the primary operational link among TA Leads Program Leads and Functional Area Geo Leaders; coordinate readiness for key milestones (e.g. 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 (e.g. 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 (Global Data Management & Standards) standards tools and processes ensuring SOP (Standard Operating Procedure) ICH-GCP (International Council for Harmonization Good Clinical Practice) 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 (e.g. TAST Therapeutic Area Standards Team TA DRC Data Review Committee).

Promote collaboration and continuous improvement across Clinical Data Manager (Clinical Data Management) 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 (but not limited to) 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 worklife 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.

Technical skills

Deep experience leading end-to-end clinical data management for trials including database design/build UAT (User Acceptance Training) 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 (Electronic Data Capture) and connected systems (e.g. labs IRT Interactive Response Technology 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 (Clinical Data Interchange Standards Consortium) standards (CDASH Clinical Data Acquisition Standards Harmonization SDTM Study Data Tabulation Model Define-XML) metadata management and controlled terminologies (e.g. LOINC Logical Observation Identifiers Names & Codes)

Strong working knowledge of SOPs ICH-GCP 21 CFR Part 11/Annex 11 and privacy expectations applying risk-based data-driven approaches (RBQM Risk Based Quality Management).

Non-technical skills

Exceptional communication and collaboration skills enabling effective leadership across cross-functional global and geographically diverse 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 & experience

Bachelors of Arts or Science (or equivalent educational experience) in Nursing Pharmacy Life sciences Allied Health Data / Information technology or Medical Technology with 10 years of experience in clinical data management clinical trial operations or related field including 3 years of people management experience. Demonstrate deep SME (Subject Matter Expert) skill in relevant discipline.

OR

Bachelors of Arts or Science (or equivalent educational experience) in any field not listed above with 15 years of experience in clinical data management clinical trial operations or related field including 3 years of people management experience. Demonstrate deep SME (Subject Matter Expert) 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 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 any field not listed above with 13 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.

AND

Demonstrated experience in leading geo diverse cross functional Teams in delivery of clinical data management or clinical trial operations strategy execution and submissions (Inspections & Health Authority Interactions & Responses).

Required Skills:

Adaptability Adaptability Audit Trails Business Decisions Clinical Data Management Collaborative Leadership Data Auditing Data Validation Decision Making eCRF Enterprise Leadership Ethical Standards Goal Setting Good Clinical Data Management Practice (GCDMP) Good Clinical Practice (GCP) Influencing Skills Leadership Theories Mentoring Staff Metadata Management Operational Strategies People Leadership Project Leadership Situational Leadership Stakeholder Negotiations Standards Compliance 9 more

Preferred Skills:

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Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

08/31/2026

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