Senior Manager Program Data Delivery

Career Category Clinical Development Job Description Role Description:   The Program Data Delivery Sr Manager p rovide s   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 m anage s   and mentor s   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 a ct s   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 2 years of life science, computer sciences, business administration experience OR   - Master’s Degree and 6 years of life science, computer sciences, business administration experience OR   - Bachelor’s degree and 8 years of life science, computer science, business administration experience OR   - Associate’s degree and 10 years of life science, computer science, business administration experience OR   - High school diploma / GED and 12 years of life science, computer science, business administration experience   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 :   - 7   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 .   .