Program Lead II, Data Management - Oncology ( Remote Opportunities)

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

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

Qualifications

• Bachelor's degree in business, management information systems, computer science, life sciences or equivalent. Master's preferred. PMP Certification or Lean Six Sigma Green Belt desired.

• Must have 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. Management of a clinical trial from initiation through to completion in a lead role is preferred

• Rave experience

• elluminate experience is preferred, but not required

• 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

• Veeva and SpotFire experience preferred

Additional Information

Applicable only to applicants