Study Start up and Feasibility Senior Manager
About The Position
This position executes the strategic oversight of the clinical trial start-up and feasibility functions for both dialysis and non-dialysis clinical trials. This position is responsible for independently managing complex processes, resolving operational barriers, and driving the strategy for study feasibility and site activation This role serves as the primary subject matter expert and liaison between Business Development, Project Managers, Regulatory, Contracts/Budget, and Operations to ensure rapid clinical trial start-up and accurate feasibility assessments. Sr. Manager positions sites for maximal operational success and financial return by leveraging data-driven insights and strategic cross-functional collaboration. Key areas: Feasibility Strategy: Lead the assessment of new protocol opportunities, analyzing site capabilities and patient populations to determine trial viability and strategic fit. Strategic Execution: Execute the end-to-end start-up strategy, from initial feasibility through site activation, ensuring alignment with organizational goals. Process Improvement: Proactively identify inefficiencies and drive continuous improvement initiatives to reduce start-up timelines and enhance data quality.
Responsibilities
- Strategic Feasibility Management Lead the comprehensive feasibility process for potential clinical trials, including the management, review, and submission of sponsor feasibility questionnaires.
- Analyze protocol requirements against DCR site network capabilities, patient populations, and historical performance data to provide strategic recommendations on site selection.
- Maintain and optimize a robust database of site intelligence (capabilities, equipment, patient demographics) to support "data-driven" feasibility submissions and attract new business.
- Collaborate with Business Development to present attractive, data-backed feasibility assessments to clients, influencing sponsor site selection decisions.
- Study Start-Up Oversight & Execution Execute the strategy for study start-up across the site network, resolving complex implementation hurdles independently with limited oversight.
- Conduct deep-dive protocol assessments to identify potential operational risks or implementation barriers; develop and execute mitigation plans in partnership with stakeholders.
- Oversee the successful activation of sites, serving as the primary point of escalation for clients and internal teams regarding start-up timelines and requirements.
- Financial & Operational Stewardship Perform high-level assessments of Budget and Contract items to identify non-standard processes or risks; recommend solutions
- Manage and oversee requirements to ensure financial stewardship and site operational readiness.
- Continuous Improvement & Innovation Design, recommend, and implement process improvements for all start-up and feasibility activities to enhance efficiency and quality.
- Analyze metrics and trends to report on start-up performance and feasibility success rates to leadership.
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 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
