Program Lead II, Data Management - Immunology TA (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

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.

• 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

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Qualifications

This position can sit remote

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

• 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

Additional Information

Applicable only to applicants