Program Lead II, Data Management - Immunology TA (Remote Opportunities) - Jobs in New Jersey

Job Description

AbbVie Data Science is the best-in-class team within its cross-industry peer group and isresponsible for bringing people, process, and technology together to generate business value fromclinical trials data. Our operational model is exemplified through execution and innovation. This roleis key to ensuring successful delivery against the program- and study-level accountabilities assignedto 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 #39; 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 #39;s (Master #39;s preferred) degree in business, management information systems, computer science, life sciences or equivalent. Master #39;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.
• 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#39;essence #39; and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie #39;s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Travel: Yes, 5 % of the TimeJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $95,500Maximum Salary $181,500