Program Lead II, Data Management - Oncology

Job Description
Purpose
AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
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
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required