Role Description:
The Program Data Delivery Sr Manager provides program-level oversight and accountability for data delivery across multiple studies, ensuring alignment and consistency in database readiness, data cleaning, reconciliation, and lock execution. This role ensures cross-study cohesion and serves as the accountable data management voice at the program level.
The Sr Manager manages and mentors a pod of Study Data Delivery Leads and Central Monitors, setting expectations, driving adoption of best practices, and ensuring performance consistency across the program to elevate quality and efficiency across the entire portfolio. This role acts as the escalation point and strategic advisor for study-level data issues, balancing tactical resolution with a program-wide perspective.
Roles & Responsibilities:
- 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.
