Program Lead III, Data Management - Branchburg, United States - AbbVie

AbbVie Branchburg, United States

1 month ago

Full time

Description

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description

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 Data and Statistical Sciences.

Responsibilities

Aligns DSS study teams with program- and study-level strategies. Supports governance of assigned programs and studies, both within and outside DSS. 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 DSS. Coordinates associated DSS 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 DSS 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 Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
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 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 orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelievesingood faith it will pay for this role at the time of this posting based on the job grade for thisposition.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays,sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible to participate in our short-term incentiveprograms.

This job is eligible to participate in our long-term incentiveprograms. Note: No amount of payis considered to bewages or compensation until such amount is earned, vested,anddeterminable.The amount and availability of any bonus, commission, incentive, benefits, or any other formofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistentwithapplicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

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