Dir, Clinical Data Mgmt

Job Description

The Director, Safety Data Management Portfolio Resource Operations Specialist provides leadership and governance for capacity planning, resource forecasting, and portfolio performance management across SDM (Safety Data Management). This role drives standardization of metrics, tools, and forecasting processes, ensuring data integrity and actionable insights to enable senior management decision-making. The Director partners cross-functionally and globally to implement enterprise-wide performance tracking and operational review frameworks.

Responsibilities

Forecasting, Capacity, and Portfolio Management:

• Consolidate functional area inputs to produce reliable demand outlooks; refine allocation algorithms to ensure the Book of Business is delivered on time and to standard.
• Design, validate, and operate capacity and portfolio models; integrate performance, financial, and resource data to inform transparent decisions and long-range planning.
• Drive productivity optimization including business case development cost benefit analysis, and value realization, leveraging process engineering tools where applicable.
• Drive the strategy and implementation of standardized forecasting tools, metrics, processes, and other operational tools, dashboards, and visualizations
• Lead operating-model optimization within SDMunder direction of leadership, translate outcomes into action plans and track through implementation.

Operational Governance, Execution, Metrics:

• Lead operational metric definition and governance (sources, cadence)
• Align functional areas to set yearly objectives and monitor progress to ensure successful, on-time achievement.
• Improve accuracy, timeliness, and automation of operations data pipelines.
• Implement and monitor functional area KPIs and long-term quality plans; build repeatable pipelines and automation; trigger RCA/CAPA and verify sustained improvement.
• Provide subject-matter expertise for automation and analytics solutions supporting PROS (Portfolio and Resource Operations Specialist) operation; identify automation, AI, and digital opportunities to improve forecasting accuracy and process efficiency
• Coordinate resource and financial forecasting, contracting, and invoicing; track variances and data integrity and publish reconciled views as required.
• Establish continuity frameworks for peak volumes, holiday coverage, and geographic shifts in demand.
• Ensure efficiencies from tool or system releases are captured and incorporated into capacity and resource models.
• Champion Human-First Organization principles in process and tooling decisions and ensure changes improve clarity, workload balance, and decision quality.

Training, Communication, Change Management

• Own role-specific curriculum within the functional area and co-lead GDMS (Global Data Management Standards)-wide training within scope; track adoption and benefit.
• Lead functional area-specific communications and change management aligned with GDMS/GCTO (Global Clinical Trial Operations).
• Partner with functional leaders to align resource deployment with milestones and priorities
• Collaborate with functional leaders to maintain and evolve talent strategy, including career pathways, training onboarding, job descriptions, and succession planning.

Enterprise Cross-Functional Representation:

• Represent the functional area in cross-functional and cross-geography metrics, governance, and operations review forums; set deliverable standards and coach contributors to meet quality and timelines.
• Engage cross-geo stakeholders to assess compliance, performance, and quality metrics for operational consistency.
• Support long-term quality management plans; participate in and lead strategic and tactical special projects as needed.

Technical Skills

• Ability to integrate data (including operational, capacity, and financial) from multiple sources and implement repeatable pipelines and automation for timely, accurate refresh.
• Ability to translate analytics into business recommendations with scenarios, trade-offs, and impact sizing.
• Ability to apply cross-functional planning, cost management, and resource prioritization to clinical data operations scenarios.
• Strong understanding of forecasting, budgeting, and accruals; able to read plan/forecast/actuals and tie them to operational drivers.
• Ability to link portfolio management, financial planning, and performance into unified decision models.
• Familiarity or proficiency with functional operational systems, performance dashboards, and workforce analytics data.
• Demonstrated ability to lead metric governance (definitions, sources, standardization, QC [Quality Control] / reconciliation, and cadence) and ensure one source of truth across the functional area.
• Deep experience with Power BI/Tableau and Excel (advanced modeling) for dashboards and what-if analysis.
• Familiarity with change management frameworks for organizational/process changes.
• Understanding RCA/CAPA methodologies for sustained improvement.
• Ability to design and validate capacity and portfolio models for large organizations (500 HC); establish KPI definitions and targets; experience operational forecasting across regions/functional areas.

SDM-specific Technical Skills

• Ability to interpret operational, capacity, and financial data (including variance analysis and trend interpretation)
• Understanding of data integrity, metric standardization, and QC / reconciliation practices.

Non-technical knowledge, skills, and abilities

• Fluent in English; exceptional communication and influencing skills, with the ability to clearly convey complex issues and engage stakeholders across functions, geographies, and levels.
• Ability to distill complex issues into decision-ready narratives; frame options, risks, and recommendations to influence senior decisions.
• Ability to drive adoption of standardized methods/ways of working; mobilize cross-functional champions and measure uptake.
• Leads through influence across functions and geographies; mentors teams/global cohorts and provides structured feedback.
• Aligns senior stakeholders on objectives, interfaces, and responsibilities; enforces clean handoffs and resolves conflicts.
• Effective facilitator of decision-making, coordinating the work of others and driving timely resolution of complex issues.
• Ability to organize and coordinate cross-team work, manage milestones, escalate risks, and maintain momentum toward deliverables.
• Strong organization and prioritization skills, managing multiple deliverables, including risk/change control and stakeholder/vendor alignment.
• Demonstrated resilience and composure under pressure, maintaining sound judgment and alignment with organizational priorities; ability to manage escalations and drive consensus on process and technology improvements.
• Continuous improvement orientation, identifying opportunities to enhance ways of working, tools, and governance.
• Ability to collaborate and problem-solve across business and technical functions, bridging perspectives to reach practical solutions.

Enterprise Leadership Skills

• Networking Partnerships | Builds strategic partnerships across GDMS, IT, Finance, GCTO stakeholders, and process owners to align portfolio priorities, resolve cross-functional constraints, and drive transparency in performance, capacity, and funding decisions across geographies.
• Business Savviness | Drives disciplined portfolio and resource execution by maintaining accurate forecasting models, workload allocation mechanisms, and standardized dashboards that ensure balanced operations, timely delivery, and data integrity across the functional area.
• Influence | Influences senior stakeholders by presenting clear, data-backed insights and trade-off scenarios, securing alignment on resourcing, funding, and operational priorities that advance shared enterprise objectives.

Qualifications Experience

• Bachelor’s Degree and minimum of 10 years experience in capacity planning, resource forecasting, and portfolio performance management (or related discipline), including:
• Demonstrate deep subject matter expertise in relevant discipline, people management skills

OR

• Advanced Degree (Masters or Doctorate) and minimum of 8 years experience in capacity planning, resource forecasting, and portfolio performance management (or related discipline), including:
• Demonstrate deep subject matter expertise in relevant discipline, people management skills

Required Skills:
Ability to Coordinate, Ability to Coordinate, Accountability, Business Agility, Business Alignment, Business Metrics, Change Management, Clinical Data Management, Clinical Study Management, Clinical Study Protocols, Competency Management, Data Management, Data Processing, Data Validation, Decision Making, Enterprise Leadership, Ethical Standards, Executive Leadership, Good Clinical Practice (GCP), Mentoring Staff, Metrics Development, Negotiation, Operations Management, Process Standardization, Progress Monitoring {+ 7 more}

Preferred Skills:
Current Employees applyHERE

Current Contingent Workers applyHERE

Search Firm Representatives Please Read Carefully

Merck Co., Inc., Rahway, NJ, USA, also known as Merck Sharp Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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:
09/11/2026*A job posting is effective until 11:59:59PM on the dayBEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFORE the job posting end date.

Requisition ID: R415322