Program Lead II, Clinical Data Strategy and Operations

AbbVie Clinical Data strategy and Operations (CDSO) 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 key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences (DSS).

• Represents DSS as the CDSO Program Lead within the cross-functional study team; aligning study teams with program and study-level strategies from the CDSO perspective.
• Provides expertise on Data Management ensuring quality and timely delivery of all CDSO deliverables
• For assigned programs and studies, the CDSO PL acts as single point of contact and is accountable for data management activities and timelines, collaborating with the cross-functional teams as needed.
• Responsible for ensuring the quality of all CDSO deliverables; working in conjunction with our clinical technology teams and external partners (e.g.  clinical database development (e.g. EDC, IRT, eCOA), data quality review, trending, Data Management Plan, etc.)

• Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, track study progress, and 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, as well as industry trends, data standards, and clinical technologies of importance for data management and contribute to enhancing capabilities and operational efficiencies.
• If assigned, participates as the CDSO study owner in regulatory inspections and internal quality audits
• Conducts study execution “lessons learned”
• 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, which may include indirect supervision of employee as well as supervising the work of contract resources
• Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives

• Bachelor’s degree degree in business, management information systems, computer science, life sciences or equivalent. 
• 6+ years of data management / pharma or biotech / clinical research / health care experience
• In-depth understanding of clinical trial processes and clinical technologies (e.g. EDC, IRT, eCOA), preferably RAVE
• Working knowledge of electronic document management systems
• Management of a clinical trial from initiation through to completion in a data management lead role
• Understanding of ICH and GCP guidelines
• Demonstrated performance as a functional leader
• Demonstrated ability to influence others without direct authority
• Demonstrated ability to successfully coach / mentor
• Demonstrated effective communication skills
• Demonstrated effective analytical skills

Nice to have:

• Master’s degree
• PMP Certification or Lean Six Sigma Green Belt
• Understanding of relevant regulatory requirements and CDISC Standards

Applicable to California Applicants Only 

• The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.

This range may be modified in the future. 

• The salary range is (minimum: _$96,000 to maximum:_$188,000) 
• This job is eligible to participate in our short-term incentive program 
• This job is eligible to participate in our long-term incentive programs 

• We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. 
  • 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 discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. 

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.