Clinical Data Strategy and Operations Program Lead I - Northlake, United States - AbbVie, Inc

AbbVie, Inc Northlake, United States

4 weeks ago

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 at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS
Study Team and represents DS as a member of the cross-functional study team
For assigned programs and 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 at the study level.
Interacts with and influences cross-functional team members to achieve program 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. If assigned, 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
Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives
Conducts study execution "lessons learned" across functions
May include indirect supervision of employee as well as supervision of work of contract resources

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

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

Additional Information

Applicable only to applicants

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