Clinical Data Strategy and Operations Program Lead III - Oncology- HYBRID Job Florham Park area,New Jersey USA,Management

About Abb Vie

Abb Vie'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 Abb Vie, please visit us Follow @abbvie onLinked

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Company Description

Purpose

Job Description

Abb Vie 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, Abb Vie 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

Bachelors degree in business, management information systems, computer science, life sciences or equivalent. Masters 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…