Job Description
The Senior Director, Study Data Services reports directly to the Geo Lead & Global Capabilities Lead (CDM Services) with oversight of the assigned sub-function. The role owns the multi-year strategy, policies, and single-source-of-truth governance for portfolio and resourcing; chairs enterprise QBRs (Quarterly Business Reviews)/steercos, and arbitrates cross-vertical priorities, funding cases, and demand–supply decisions. It sponsors the automation/analytics roadmap with fellow DI&A leaders, stewards the budget for their sub-vertical and vendor ecosystem, and ensures inspection-ready controls worldwide. The Senior Director sets function-level Objectives and Key Results, publishes executive dashboards, and leads talent strategy, building leaders of leaders and sustaining performance at scale.
Responsibilities
General:
Strategically drive objectives of GCTO (Global Clinical Trial Operations)
Provide strategic direction within assigned functional area; inspires teams toward shared goals to drive our Company's Book of business and GCTO goals and objectives.
Develops functional area-specific objectives aligned with organizational priorities that are ambitious yet achievable and collaborate with cross-functional (non-GDMS [Global Data Management and Standards]) leadership and enterprise support functions within assigned geography to achieve strategic and operational goals and objectives.
Plans resources and sets strategies to improve efficiency and impact
Ensure consistent execution, quality, and compliance
Evaluate and implement process/technology improvements that enhance scalability, standardization, and quality; support next-gen operating model adoption.
Communicate a clear narrative to executives on options, risks, trade-offs, and decisions; represent assigned DI&A SIM (Study Integration Manager) in enterprise forums and audits.
Oversee learning plans for functional staff; align with GDMS/GCTO curricula.
Serve as escalation point for issues with assigned teams.
Oversee governance & risk management
Ensure DI&A inspection readiness and compliant controls for operational data, change management, and system releases within functional area.
Establish Objectives & Key Results and performance metrics for the function; publish executive dashboards and drive accountability for outcomes.
Run scenario planning and resilience playbooks for demand shocks, surges, and reprioritization; protect critical work and service levels.
DI&A-specific:
Define and lead the operating model and multi-year optimization strategy for the assigned functional area (incorporating DI&A & GDMS global strategic objectives), while driving adoption of leading-edge technology deployment principles across relevant GCTO organizations and functions.
Set people-first organization standards for assigned functional area (culture, ways of working, workload safeguards) and hold peers and team members accountable for outcomes.
Own the training strategy and academy footprint for function/resources; measure ROI (Return on Investment) and build leadership pipelines.
Study Data Services-Specific:
Drive the programming services of the Clinical Trial and all components in its scope to ensure that the Clinical Trial is managed with quality and adherence to timelines
Own the end-to-end portfolio of clinical trials supported by the GDMS organization, setting direction and priorities, overseeing risk and issue management, and ensuring delivery quality and timelines across the our Company's book of work
Drive Good Programming Practices in assigned functional area, collaborate with similar functions in other organizations within our Company and in the industry, and drive full adoption of deployed systems and leading-edge technologies
Work with the cross-functional teams to ensure that the clinical and operational dataflow is streamlined, standardized and automated
People Management Responsibilities:
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.
Lead recruiting and hiring; manage sensitive employee-relations matters (including separations) in partnership with HR (Human Resources).
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.
Technical skills
Strong understanding of end-to-end data management, including how data is collected, cleaned, governed, and reported, and how operational and quality metrics are used to monitor performance.
Proven experience implementing risk-based and digital data practices, using data and automation to focus effort where risks are highest.
Advanced ability to use analytical and forecasting tools (e.g., dashboards, capacity models) to inform resourcing, planning, and operational decisions.
Expertise in KPI and data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth.
Proven financial stewardship of organizations, including budget ownership, development of investment cases, workforce cost modeling, and value realization frameworks.
Demonstrated expertise in leading vendor strategy, including ecosystem design, global SLAs (Service Level Agreements) / SOWs (Statement of Work) development, performance scorecard design, and contract risk management.
Expertise in data-product governance (definitions, lineage, quality controls, lifecycle) to maintain a global single source of truth.
Expertise in automation / AI-enabled planning & reporting with fluence in validation expectations and limitations in regulated environments.
Enterprise-level mastery of AI-First operating-model governance (standards, controls, ethics) and tool-stack roadmap stewardship across geographies
Strong knowledge of the SDLC (Software Development Life Cycle), CSV (Computer System Validation), data privacy, and inspection-readiness requirements, and how to apply them when introducing or changing systems at scale.
Ability to define and enforce standards for integration, reuse, and scalability of data, tools, and solutions.
Deep knowledge of ICH (International Council for Harmonisation) and GCP (Good Clinical Practice) guidelines, and how these regulations apply to clinical data management activities.
PS Specific:
Strong understanding of TAs (Therapeutic Areas) within our Company's Book of Business
Ability to evaluate, select, and apply new technologies (including automation/AI) in data management.
Advanced clinical programming skills and experience designing reusable code frameworks and integration patterns/APIs.
Deep understanding of relational databases, data modeling, and controls that ensure data quality and integrity.
Proven track record deploying and governing major vendor platforms, from implementation through ongoing optimization.
Expert knowledge of clinical data and interoperability standards (e.g., CDISC [Clinical Data Interchange Standards Consortium], HL7/FHIR [Health Level Seven/Fast Healthcare Interoperability Resources]) and their use in compliant data exchange.
Non-Technical skills
Strong stakeholder management and collaboration capabilities, fostering trust and effective partnerships to deliver consistent, high-quality outcomes.
Exceptional communication skills, with the ability to communicate with both the technical and business areas.
Demonstrated ability to lead through influence, motivating and guiding cross-functional and virtual teams without direct reporting authority.
Highly adaptable and resilient, able to prioritize and perform effectively under pressure in a fast-changing environment.
Works independently with accountability, exercising sound judgment and initiative while maintaining alignment with organizational priorities.
Effective facilitator of decision-making, coordinating the work of others and driving timely resolution of complex issues, integrating business, operational, and people dimensions into decision-making
Fluent in English with excellent written and verbal communication skills, able to clearly convey complex or technical information to diverse audiences.
Executive influence and storytelling to VP (Vice President)/SVP (Senior Vice President) level - driving fast, well-governed decisions across complex stakeholder landscapes.
Ability to create a high-performance, inclusive culture that attracts, develops, and retains senior talent.
Demonstrated ability to drive large-scale change leadership; designs communications, training, and adoption strategies to standardize ways of working globally.
Demonstrated disciplined prioritization, focusing teams on critical metrics and initiatives that drive sustained value.
Enterprise Leadership Skills
Strategic Planning | Plans strategically by gathering information and identifying key issues, dependencies, and relationships critical to achieving long-range goals; commits to a course of action after developing and evaluating alternatives based on facts, available resources, constraints, and organizational values.
Networking and Partnerships | Cultivates networks and partnerships by initiating and maintaining strategic relationships with stakeholders and potential partners inside and outside the organization who provide the information, ideas, expertise, and influence needed to deepen understanding of business issues and achieve business goals.
Change Catalyst | Leads change by driving the organizational and cultural shifts needed to achieve strategic priorities; catalyzes new approaches to improve results by evolving culture, systems, and services; helps others overcome resistance and adopt change.
Qualifications & experience
Bachelors in Arts or Sciences degree with 13 years of experience working in the relevant field Life Sciences or Pharmaceutical industry, which includes a minimum of 5 years of people management experience, Demonstrated deep SME (Subject Matter Expert) in the area of programming, integration and technology ecosystem and partner management
OR
Advanced degree (Masters or Doctorate) with 10 years of experience working in the relevant field Life Sciences or Pharmaceutical industry, which includes a minimum of 5 years of people management experience. Demonstrated deep SME in the area of programming, integration and technology ecosystem and partner management
AND
clinicaltrialjobs
EligibleforERP
#GDMS
Required Skills:
Change Management, Clinical Data Management, Clinical Study Management, Cross-Functional Collaboration, Data Analysis, Data Validation, Good Clinical Practice (GCP), Health Data Interoperability, Key Performance Indicators (KPI), Operating Models, People Leadership, Risk Management, Stakeholder Relationship Management, Strategic Planning, Training and Development
Preferred Skills:
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