Clinical Data Strategy and Operations Program Lead III

Job Description

Job Description

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

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 a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy and Operations (CDSO).

Responsibilities:

• Aligns CDSO study teams with program- and study-level strategies. Supports governance of assigned programs and studies, both within and outside CDSO. Assigned programs may include programs of any size or any complexity.
• For assigned programs, 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 at both the program and study levels.
• Interacts with and influences all levels of management and cross-functional team members to achieve program objectives. Represents DS in cross-functional forums and, if assigned, leadership meetings.
• 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 of own, as well as studies managed by the team. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions.
• Ensure 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. Coordinates and participates as the DS study owner in regulatory inspections and internal quality audits.
• Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance.
• Responsible for coaching and mentoring team members, as well as providing input into their development.
• Leads CDSO and cross-functional innovation and process improvement initiatives.
• If assigned, responsible for identifying training needs and standardizing and facilitating training solutions for DS roles. Conducts “lessons learned” across functions.
• May include direct and/or indirect supervision of staff, as well as contract resources.

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 8+ years of pharma / clinical research / data management / health care experience or 10+ years of project management experience (and / or applicable work experience).
• In-depth understanding of clinical trial processes and involved functional stakeholders, and clinical\ technology. Management of a clinical trial from initiation through to completion in a lead role is required.
• Demonstrated performance as a cross-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 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. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.  

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