Job Summary
This is a hybrid position requiring a minimum of 3 days on-site in Basking Ridge, NJ or Armonk, NY. Remote work is not an option for this role.
Role Description
The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines, and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations, and company Standard Operating Procedures (SOPs) within assigned program(s).
Duties and Responsibilities
* Be responsible for the overall success of the clinical study team(s) within a program(s)
* Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues, or changes that may impact quality, timelines, and/or budget; provide clinical program level updates to partners as requested
* Provides operational insight into feasibility, timeline, and cost estimates during clinical program/study development
* Coordinates clinical study timelines within a clinical program(s)
* Provides input and operational insight into Clinical Study Concepts (CSC)
* Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol
* Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up, and conduct phases of studies
* Ensure consistency within the program and development of standard processes within CTM
* Leads all aspects of clinical study budgets within a program: ensures review, presentation, and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate
Requirements
* Advanced interpersonal & leadership skills
* Ability to provide operational strategic direction and guidance for clinical programs
* Applies sophisticated technical knowledge to solve highly complex issues
* An understanding of relevant industry trends
* Strong analytical skills with a data-driven approach to planning, executing, and problem-solving
* Advanced interpersonal skills via verbal, written, and presentation abilities
* Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
* Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads)
* Budget management expertise and strong financial competence
* Consistent track record of building, leading, and developing productive teams and collaborations
* Expert project management skills, cross-functional engagement, and organizational skills
Qualifications
To be considered, you must have a Bachelor's degree and a minimum of 12 years of relevant pharmaceutical industry experience, 8 years within Clinical Trial Management. Experience with early phase clinical trials is highly preferred.
Salary Range
$198,000.00 - $330,000.00