Remote Data Science Program Lead II, Data Management - Oncology

Description:

• The Data Science Program Lead II will 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.
• This role includes overseeing all EDC and IRT vendor contracts for assigned clinical trials and supervising all Data Sciences staff, including equivalent CRO staff.
• The individual will co-represent Data and Statistical Sciences at meetings with the FDA and regulatory agencies regarding assigned clinical trials.
• The lead will manage the clinical study team in developing key clinical trial systems, study conduct, and study close-out related to Data and Statistical Sciences operational activities.
• Responsibilities include creating and managing a Data Sciences communications plan for all assigned clinical trials and exercising informal authority over Data Sciences study team members’ daily tasks and timelines.
• The position requires managing 4 to 7 clinical trial startups concurrently and planning and managing all Data Sciences timelines and deliverables for assigned clinical trials.
• The lead will complete trial-specific Statements of Work (SoW) based on parameters supplied by the Master Service Agreement (MSA) for EDC, ePRO, and IRT vendors.
• The role involves managing and maintaining vendor budgets for assigned clinical trials and processing flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.
• The individual will align DSS study teams with program- and study-level strategies and act as the single point of contact and accountable operational lead from DSS for assigned programs and studies.
• The lead will utilize operational analytics and project management tools to optimize execution of programs and studies, manage internal and external resources, track study progress, and prepare study status reports.
• Ensuring adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) is essential.
• The role includes participating in oversight of vendors, providing feedback related to clinical trial operations, coaching and mentoring team members, and leading DSS innovation and process improvement initiatives.

Requirements:

• A Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent is required; a Master’s degree is preferred.
• Candidates must have 6+ years of experience in pharma, clinical research, data management, or health care, or 8+ years of project management experience.
• An in-depth understanding of clinical trial processes and clinical technology is necessary, with management experience of a clinical trial from initiation to completion preferred.
• Experience with Rave is required, and experience with elluminate is preferred but not mandatory.
• Demonstrated performance as a functional leader and the ability to influence others without direct authority is essential.
• Candidates should have effective communication and analytical skills, along with the ability to successfully coach and mentor in a matrix environment.
• Experience with Veeva and SpotFire is preferred.

Benefits:

• AbbVie offers a comprehensive package of benefits including paid time off for vacation, holidays, and sick leave.
• Medical, dental, and vision insurance are provided to eligible employees.
• Employees are eligible to participate in the company's short-term incentive programs.
• The compensation range for this position is between $103,500 and $197,000, depending on various factors including geographic location.