Job ID: BH99840
Category: Legacy Clinical, Clinical Trial Manager
Location: REMOTE (US)
- Partners with CROs and Clinical Operations to develop and deliver rapid, accurate and robust assessments of program and country feasibility, oversight of site identification/site feasibility, and timing of key start-up and recruitment milestones. Focusing on data driven estimates, benchmarking assumptions, robust scenarios & accurate planning.
- Works under close supervision of Senior Director – Feasibility Group Lead to support therapeutic areas as needed (i.e. therapeutic area agnostic).
- Supports and Manages processes relating to Program, Protocol, Country & Site feasibility
- Supports Patient Recruitment Plans in collaboration with Patient Recruitment Strategy Group
- Supports Protocol Optimization Strategies
- Participates in global initiatives to improve operational efficiencies
- Supports Clinical Operations in the build of data driven study assumptions from operating plan to study work order
- Support/advise the Site Identification and Site Feasibility Process
- Maintains continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning
- In support of Clinical Operations, responsible for delivery of early feasibility (before core protocol elements are available)
- Support Clinical Operations roles early in the development cycle, providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions.
- Support Clinical Operation roles in Optimizing Operational Protocol Design
- Support Clinical Operation roles in ensuring effective scenario generation & planning; comparing past performance data and proposed scenarios from CROs
- Partner with CROs to build system, processes and work practices that drive rapid, accurate and robust assessments of program, country and protocol feasibility (country, site) as well as the timing of key recruitment milestones.
- Support the development of data driven study / program assumptions.
- Support governance processes by providing early feasibility information leveraging existing data sources and organizational knowledge/expertise
- Partners with CROs, Clinical Operations teams, and RU/BU partners to improve overall study start up metrics and implement simple processes.
- Operational responsibility for delivering to agreed set of KPIs for assigned protocols.
- Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
- Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies
- Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery
QUALIFICATIONS: Candidates for this job would have the following levels of industry experience in Clinical Research/Clinical Operations at minimum:
- BS/Equivalent – 4 years
- MS – 3 years
- PhD/MD – 2 years
Feasibility experience is not required, in depth training will be provided:
- A broad based experience clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations
- History of success in a customer service role with demonstration of meeting customer expectations.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
- Well-developed strategic planning, observation, analytical operational execution and problem-solving skills
- Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
Technical Skill Requirements
- Demonstrated knowledge of clinical research processes and regulatory requirements.
- Demonstrated success/results in prior roles including matrix organization
- Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies
- Demonstrated ability to manage projects and cross-functional processes required
- Demonstrated platform skills; experience presenting to non-science populations