Senior Manager Program Data Support

nsibilities:

• Build and maintain the program data delivery plan covering all studies, key milestones, and inter-study dependencies.

• Standardize program practices for DMP, IDRP, query management, reconciliation, and lock procedures.

• Lead Study Data Delivery Leads and Central Monitors; provide direction, review their performance, and align their execution.

• Review program metrics (database build progress, query burden, reconciliation status, risk signals) and ensure actions have appropriate follow-through, actions, and closure.

• Chair program-level issue reviews and coordinate cross-functional resolutions with Clinical Operations, Biostats, Safety, Systems, and vendors.

• Coordinate program resources and surge support, including associates and FSPs, to keep critical paths green.

• Consolidate program risk registers and ensure mitigation plans are tracked to closure.

• Prepare program data delivery status for governance, highlighting risks, decisions, and trade-offs.

• Mentor study-level leads on planning, communication, stakeholder management, and overall execution.

Basic Qualifications and Experience:

• Doctorate Degree and 12+ years of life science, computer sciences, business administration experience OR

• Master's Degree and 12+ years of life science, computer sciences, business administration experience OR

• Bachelor's degree and 12+ years of life science, computer science, business administration experience OR

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Preferred Experience:

• 10+ years work experience in life sciences or medically related field, including 5 years of managing data on biopharmaceutical clinical research experience

• Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials

• Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)

• Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management

Functional Competencies:

Must-Have Competencies:

• Demonstrates ability for end-to-end management of study deliverables, budgets, timelines, and performance metrics (KPIs) to optimize trial execution.

• Ability to identify operational risks based on protocol design and implement innovative mitigation strategies. Identify and manage study issues, communicating and/or escalating appropriately.

• Experience with overseeing study budgets and financial operations, reviewing/approving site expenditures, and optimizing resource allocation to ensure cost efficiencies.

• Interprets clinical and operational data to guide trial execution and identify study trends. Collaborates with biostatistics and data management to ensure data integrity.

• Able to identify and implement opportunities for continuous improvement into the team's working practices.

• Experience with overseeing external vendors (Contract Research Organizations, labs, imaging vendors, etc.) to drive and meet study deliverables with high quality

• Experience with developing and training teams related to clinical trial materials (e.eg., CRAs, site staff, and cross-functional teams) to ensure alignment with study protocols, regulatory requirements, and best practices.

• Experience driving and executing change initiatives ensuring adoption of new designs within function.

• Ability to manage, mentor, and develop professionals and support staff across functions & geographies, while fostering collaboration across internal and external teams for trial success.

Soft Skills:

• Strong collaboration and communication skills to engage with cross-functional teams, senior management and external stakeholders, internally and externally.

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