Program Lead II, Data Management

Summary

Join AbbVie's Data Science team, a best-in-class group responsible for leveraging clinical trial data to generate business value. This key role ensures successful delivery of program and study accountabilities within Data and Statistical Sciences (DSS). You will oversee Data Science timelines and deliverables for assigned clinical trials, supervise staff, and represent DSS in meetings with regulatory agencies. Responsibilities include managing vendor contracts, budgets, and quality assurance. You will lead clinical study teams, act as a single point of contact for DSS, and ensure adherence to regulations and guidelines. This position requires strong leadership, communication, and analytical skills, along with experience in clinical research and data management.

Requirements

• Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent
• 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience)
• In-depth understanding of clinical trial processes and clinical technology
• Rave experience
• Demonstrated performance as a functional leader
• Demonstrated ability to influence others without direct authority
• Demonstrated ability to successfully coach / mentor in a matrix environment
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Responsibilities

• Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians
• Oversee all EDC,and IRT vendor contracts for assigned clinical trials
• Supervise all Data Sciences staff (including equivalent CRO staff) for assigned clinical trials
• Co-represent Data and Statistical Sciences at any meetings with FDA and regulatory agencies regarding assigned clinical trials
• Lead clinical study team in the development of key clinical trial systems, study conduct and study close-out as related to Data and Statistical Sciences (DSS) operational activities. Create and manage Data Sciences communications plan for all assigned clinical trials. Exercises real, but informal authority over Data Sciences study team members’ daily tasks and timelines
• Manages 4 to 7 clinical trial startups concurrently
• Plan and manage all Data Sciences timelines and deliverables for assigned clinical trials
• Complete trial-specific Statement of Work (SoW) based on parameters supplied by Master Service Agreement (MSA) for Electronic Data Capture (EDC), electronic Patient Reported Outcomes (ePRO) and Interactive. Response Technology (IRT) vendors for assigned clinical trials
• Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events. Manage any internal quality assurance audit for assigned clinical trials
• Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team
• For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study level
• Interacts with and influences cross-functional team members to achieve program objectives
• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
• Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits
• Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance
• Responsible for coaching and mentoring team members
• Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives
• Conducts study execution “lessons learned” across functions
• May include indirect supervision of employee as well as supervision of work of contract resources

Preferred Qualifications

• Master’s degree
• PMP Certification or Lean Six Sigma Green Belt
• Management of a clinical trial from initiation through to completion in a lead role
• Illuminate experience
• Veeva and SpotFire experience

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs