Clinical Trial Manager / Feasibility Lead (REMOTE-WORK)
Position Details:
Our client, a world-leading Pharmaceutical Company is currently looking for a Clinical Trial Manager / Feasibility Lead (REMOTE-WORK) to join their expanding team.
Job Title: Clinical Trial Manager / Feasibility Lead (REMOTE-WORK)
Duration: 18 months contract
Location: Remote
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Role Summary
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).
Role Responsibilities
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 Pharmaceutical's 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
Comments:
candidate must be able to align with EST hours
Qualifications
In general, candidates for this job would have the following levels of experience in Clinical Research/Clinical Operations:
BS/Equivalent – 4 years
MS – 3 years
PhD/MD – 2 years
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
If you are qualified, available, interested, planning to make a change, or know of a friend who might have the required qualifications and interest, please call me ASAP at (732) 947-3462, even if we have spoken recently about a different position. If you do respond via e-mail please include a daytime phone number so I can reach you. In considering candidates, time is of the essence, so please respond ASAP.