[Hiring] Manager, Study Start-Up and Implementation @DaVita Kidney Care

Role Description

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 Clinical Operations.

Qualifications

• Experience in managing clinical trials.
• Strong understanding of clinical trial processes and regulations.
• Excellent communication and collaboration skills.

Requirements

• Confirm completion of, and assist with, navigation of study start-up processes, across a site network, for all clinical trials.
• Protocol assessment to identify barriers and challenges in implementation of the clinical trial including identification of third party vendors.
• In conjunction with Quality/Integration team, conduct the protocol implementation process with potential or participating sites.
• Budget and Contract assessment for each clinical trial to identify non-standard items that require special processes established for recognition of revenue or billing.
• Supports the building of the clinical trial in the CTMS (clinical conductor) to ensure that the study set up & management captures appropriate study specific processes and non-standard billable items.
• Work with both internal and external teams to ensure good communication regarding all start-up requirements and serve as escalation point for clients.
• Advocate to clients to include as many DaVita sites on studies as possible.
• Other duties as assigned.

Benefits

• Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out.
• Support for you and your family: Family resources, EAP counseling sessions, access to Headspace®, backup child and elder care, maternity/paternity leave and more.
• Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita’s online training platform StarLearning.