AbbVie

Data Sciences Program Lead II

Employer
AbbVie
Location
Irvine, California
Posted
Jul 14, 2021
Ref
2110739
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

  • 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

Qualifications
  • Bachelor’s (Master’s preferred) degree in business, management information systems, computer science, life sciences or equivalent
  • 5 to 8 years of direct clinical development experience. 2+ years of clinical development management. Phase II and III experience
  • Demonstrated strong leadership competencies with broad business orientation and experience in leading teams in the management and completion of clinical trials
  • Proven track record of successful studies (delivered on time, within budget, and with high quality)
  • Recognized leader in process development (SOPs, Global Regulations, OEC, Outsourcing) and the application of procedures to the business. Recognized as a leader and key contributor to initiatives and advancement of DSS as an organization
  • Knowledgeable in the end-to-end clinical systems development cycle
  • Demonstrated effective communication skills
  • Ability to develop advanced knowledge of major concepts of key systems
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
  • Learns fast, grasps the 'essence' and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.