Manager, Study Start-Up and Implementation (DCR)

This position will be responsible for managing the clinical trial start up process for both dialysis and non-dialysis clinical trials. Collaborates and liaises with interdepartmental team members (Business Development, Project Managers, regulatory, contracts/budget, operations, Quality) to enable a rapid clinical trial start-up, position sites for maximal success & financial return.   

This will include: 

Deep Dive into the protocol with an assessment of implementation issues or areas of concern; provide recommendations, and partner with stakeholders for necessary resolution or action plans 

Input into and assessment of Budget and contract items identified as out of normal process   

Assessment of protocol requirements of 3rd party vendors and facilitation of the oversight and management of vendors for operationalization and financial stewardship of clinical trials 

Provide Clinical Trials Management System (Clinical Conductor) support 

Initiate the lead site process with the Group Regional Managers. 

Design and provide recommendations on process improvement for all start up activities.  

Oversee successful activation of sites from feasibility through activation process, key point of contact for both clients and sites.  

This position collaborates with operation management to identify and develop processes to meet and exceed study start-up and implementation goals. This position reports to the Director of Director of Clinical Operations. 

ESSENTIAL DUTIES & RESPONSIBILITIES