Strategic Feasibility Manager

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Date: Jan 18, 2019

Location: Raleigh, North Carolina, US

Strategic Feasibility is a critical component in the execution of a clinical trial.  Strategic Feasibility Manager is a part of Program Delivery team with UCB’s Global Clinical Science & Operations (GSCO).  This position is responsible to conduct, execute and oversee Feasibility work in collaboration with CRO partners to support UCB’s clinical development portfolio ranging from phase 1 to phase 4. The scope of this role includes the following:

 

  • Utilize and synthesize various internal and external data into meaningful feasibility solutions to support UCB’s clinical programs and studies.
  • Support program/study level clinical planning; ensure accurate recruitment forecasting to maximize efficient and timely delivery of UCB’s clinical trials.
  • Oversee and execute feasibility tasks in collaboration with CRO feasibility team, from early engagement throughout country and site selection.
  • Coordinate and build consensus around program/study level planning and support stakeholders’ ad-hoc inquires.
  • Support group efforts to identify leading performance measures, enhance country and site selection strategies, and assist in the development of feasibility dashboard and other in-house feasibility tools.
  • Ensure industry best practices and high-quality deliverables consistent with all applicable guidelines and regulations.
  • Identify business improvement opportunities that improve overall GCSO’s Program Delivery, Site Engagement and Patient Engagement capabilities with the guidance of the Strategic Feasibility Lead.

 

MAJOR ACCOUNTABILITIES 

 

As the Strategic Feasibility Manager:

 

  • Define and confirm the feasibility strategy and tasks with CRO partner for each assigned study.
  • Identify and understand the attributes of a high performing country and investigator site on the study level; ensure a data-driven strategy for selecting highly effective countries and investigator sites implemented in a matrix / partnership environment.
  • Involve UCB internal experts (e.g. Clinical Program Directors/Physicians/Commercial, drug supply teams) in feasibility assessment; support efficient and effective communication and information exchange with these key stakeholders.
  • Synthesize information and data from various sources into meaningful solutions and make feasibility recommendations to the study team.
  • Work in close collaboration with Program Delivery Lead to support asset development and clinical planning on both program and study level.
  • Work in close collaboration with the Site Engagement team to conduct on-site feasibility, and to identify appropriate new or to-be-developed clinical sites and investigators.
  • Work in close collaboration with the Patient Engagement team to obtain their patient insights (e.g. focus group) into feasibility assessment, and plan the downstream patient recruitment and engagement activities on the study level.
  • Mentor new Strategic Feasibility team members and share best practice within the team.
  • Assist in ongoing evaluations with SPI partners and stakeholders to ensure that the best and most effective country and site performance information is being captured and shared; assist in study transition and harvest knowledge at study closing.
  • Support the group efforts (with the guidance of Strategic Feasibility Lead) to further develop feasibility methodologies, country/site databases, feasibility dashboard, and other in-house tools that can be utilized by Strategic Feasibility or a broader UCB team.

 

As a member of the Program Delivery team:

  • Contribute to assigned global, cross-functional interdisciplinary, high priority initiatives, and process improvements.
  • Collaborate with other members of the Program Delivery team, GCSO, Patient Value Units and other relevant interfaces, including strategic CRO partners, to ensure integration of activities and identification of areas for improvement; maintain effective working relationships with members of interfacing groups.
  • Participate in departmental activities as needed that provide operational structure for GCSO such as:
  • Policy, guidance and procedure development and maintenance
  • SOP review and update activities
  • Knowledge management and training
  • New system adoption
  • Ensure that all UCB SOPs are adhered to country/regional regulations, and GCP guidelines are followed with respect to Strategic Feasibility
  • Assist in building external networks of peers and providers to ensure UCB is at the forefront of new technologies and has the thought leadership regarding site selection / patient recruitment methodologies.
  • Travel as required (up to 10%).

 

Education and Experience

  • Bachelor's Degree 
  • A minimum of 5 years of experience in the Pharmaceutical, Biotechnology, and/or CRO industry is required with a preference towards individuals who have experience in clinical planning and/or clinical project management.
  • Proven track record of working on cross-functional projects in a global environment.
  • Previous project, team, or initiative leadership experience is preferred.
  • Good working knowledge of GCP guidelines in different regions.

 

 


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