Program Lead I - HYBRID
AbbVie · Florham Park, NJ · 1 wk ago
ConsultingFull-time
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.
About the role
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. This role ensures successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences.
Responsibilities
- Aligns DSS study teams with program- and study-level strategies.
- For assigned studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team.
- For assigned studies, acts as single point of contact and accountable operational lead from DSS.
- Coordinates associated DSS 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 DSS and cross-functional innovation and process improvement initiatives.
- Contributes to 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 at least 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.
Benefits
- Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- Eligible to participate in short-term incentive programs.