This position can be based in multiple locations globally, including Armonk, NY, Basking Ridge, NJ, Cambridge, Mass, Uxbridge, UK, and Dublin, Ireland. For US Locations, this role is on-site 4 days per week and 1 day from home. For EU locations the role is on-site 3 days per week and 1 day from home. A fully remote role is not possible for this role.
Job Description
The Program Operations Leader (POL) is responsible for leadership of and setting and implementation of 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).
The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives.
In a typical day, you will:
* Be responsible for the overall success of the clinical study team(s) within a program(s)
* Maintain 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 stakeholders as requested
* Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development
* Oversee clinical study timelines within a clinical program(s)
* Provide input and operational insight into Clinical Study Concepts (CSC)
The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management.
Key responsibilities include: driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans, provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies, ensuring consistency within the program and development of best practices within CTM.
The POL oversees 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.
The successful candidate must possess: advanced interpersonal & leadership skills, ability to provide operational strategic direction and guidance for clinical programs, advanced 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 communication skills via verbal, written and presentation abilities, ability to influence and negotiate across a wide range of senior stakeholders (i.e., functional area heads), budget management expertise and strong financial acumen, significant line management experience with demonstrated mentoring and coaching skills, extensive experience in global clinical trial operations, a working knowledge of GCP and ICH.
To be considered for this role, applicants must have a Bachelor's degree and minimum of 12 years relevant sponsor-side industry experience, 8 years within clinical trial management.