Clinical Data Strategy and Operations Program Lead I - Oncology

About the role

AbbVieClinical DataStrategy and Operationsis 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 toClinical Data Strategy and Operations (CDSO).

Responsibilities

• Aligns CDSO study teams with program- and study-level strategies. For assigned studies, leads the CDSO Study Team and represents CDSO as a member of the cross-functional study team
• For assigned studies, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams
• Interacts with and influences cross-functional team members to achieve program and study 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
• Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance
• Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources
• Participates in CDSO and cross-functional innovation and process improvement initiatives
• Contributes to study execution "lessons learned" across functions

Qualifications & Requirements

• 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 at 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and / or applicable work experience)
• Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred
• Demonstrated effective leadership skills
• Demonstrated ability to influence others without direct authority
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.