Feasibility Manager

Summary

Join Care Access as a Feasibility Manager and play a critical role in assessing the feasibility of clinical trial protocols and sites within the global Care Access Site Network. You will lead the global clinical feasibility planning process, collecting and interpreting data to determine suitable sites for studies. Responsibilities include reviewing protocols, assessing feasibility using the Feasibility Toolbox, collaborating with various teams (Business Development, Patient Recruitment, site staff, etc.), managing communication, preparing documentation, and maintaining feasibility information in the department database. The position requires expert knowledge of clinical research processes, excellent communication and interpersonal skills, and proficiency in project management. A Bachelor’s degree in life sciences or equivalent and 3+ years of relevant clinical research experience are preferred. This is a remote position with less than 10% travel.

Requirements

• Expert knowledge of general clinical research processes and Good Clinical Practice
• High level of professionalism and confidentiality required
• Excellent interpersonal skills
• Ability to manage against tight timelines and competing priorities
• Excellent written and oral communication skills
• Strong judgment and ability to make evidence-based decisions
• Proficient with Google Suite and Microsoft Office Suite
• Ability to work collaboratively across departments
• Excellent project and process management skills; ability to prioritize in a fast-paced work environment, pivot quickly based on changing business needs, and manage time appropriately
• Ability to build relationships effectively in a geographically dispersed, largely remote environment
• Minimum 3+ clinical research experience with at least 3 years of relevant experience with pre-award feasibility assessment, site identification/site selection, or equivalent experience

Responsibilities

• Lead the process of global clinical feasibility planning to support each study proposal and clinical research sites
• Collect and interpret data from business development team and trial sponsor to understand study requirements
• Review study information and using the Feasibility Toolbox as a resource, assess feasibility of conducting study at Care Access sites
• Understand site selection criteria from the sponsor
• Collect and interpret information from Care Access’s site database, site level conversations, and subject matter expert interviews to determine if the study is the right fit for Care Access
• Process collected information and identify relevant data for the Feasibility Database
• Collaborate with Patient Recruitment to generate patient funnels to understand how many patients are needed at each site to achieve the enrollment expectations established by the sponsor
• Partner with the Patient Recruitment team and site staff for appropriate intelligence and strategies for recruitment practices and plans
• Manage communication between all relevant parties on a global scale to make the best feasibility decisions, including
• ��� Business Development team
• ��� Principal Investigators and other site staff
• ��� Regional Site Managers
• ��� Site Network Leadership
• ��� Clinical Trial Managers
• ��� Study Start-Up Team
• ��� Patient Recruitment team
• ��� Vendor Management Team
• ��� Other internal and external experts, as appropriate
• Prepare required documentation for feasibility assessments and pre-study site visits
• Ensure that all information gained during the planning and feasibility phase is completely transitioned to sites, as required
• Maintain and ensure all feasibility information for each assigned project is entered in the Feasibility Department database
• Feasibility Managers may be therapeutically aligned but can expect to support a variety of sites and indications
• Other tasks, as assigned

Preferred Qualifications

Bachelor’s degree in life sciences or equivalent is preferred

Benefits

This is a remote position with less than 10% travel requirements