Data Science Program Lead II, Data Management

4 days ago

Chicago, Illinois, United States AbbVie Full time
Job Summary

We are seeking a highly skilled Data Science Program Lead II, Data Management to 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.

Key Responsibilities
  • 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.
  • Manage 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.
  • Manage 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.
  • Align DSS study teams with program- and study-level strategies.
  • Act as single point of contact and accountable operational lead from DSS for assigned programs and studies.
  • Coordinate associated DSS study teams to meet operational objectives.
  • Engage and connect global functional and cross-functional teams at the study level.
  • Interact with and influence cross-functional team members to achieve program objectives.
  • 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.
  • Anticipate and identify issues that could affect timelines or quality and develop options and solutions.
  • Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and functional quality standards.
  • Stay abreast of new and/or evolving local regulations, guidelines, and policies related to clinical development.
  • Participate in oversight of vendors and provide feedback related to clinical trial operations, issues, and trends in performance.
  • Responsible for coaching and mentoring team members.
  • Lead DSS innovation and process improvement initiatives and participate in cross-functional initiatives.
  • Conduct study execution "lessons learned" across functions.
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 6+ years of pharma/clinical research/data management/health care experience or 8+ years of project management experience (and/or applicable work experience).
  • In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred.
  • Rave experience.
  • Elluminate experience is preferred but not required.
  • Demonstrated performance as a 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.
  • Veeva and SpotFire experience preferred.
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, serving our community, and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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