OneOncology · 3 days ago
Manager, Clinical Research Study Activation
TNO - GHCR Admin | Nashville, TN
Full-time
Onsite
Mid Level
3+ years expOneOncology is a leading community-based cancer care specialist with a mission to provide high-quality cancer care and clinical research access. The Manager, Clinical Research Study Activation will oversee the study activation process for oncology clinical trials, ensuring compliance and efficiency while collaborating with various stakeholders.
Health CareOncology
Responsibilities
Ensures adherence to ICH-GCP, institutional policies, and applicable regulatory requirements during start-up
Provides operational and strategic oversight of all study activation activities, including feasibility, protocol review, budget development, contract execution, regulatory submissions, and site activation
Ensures activation workflows are standardized, efficient, and scalable across the full clinical research portfolio
Develops and maintains standard operating procedures (SOPs), work instructions, and activation tools/templates
Develops and tracks key performance indicators (KPIs) related to activation timelines, volume, and quality
Reviews oncology protocols to assess operational complexity, staffing impact, and site feasibility
Coordinates feasibility assessments with investigators, research teams, investigational drug services, lab/tissue, imaging, and ancillary departments
Ensures protocol requirements are clearly communicated and operationalized prior to activation
Leads activation-related meetings and provides clear direction, escalation, and resolution of issues
Supports portfolio-level planning by assessing activation workload, capacity, and prioritization across studies
Provides data-driven input to leadership regarding staffing needs, activation volume, and pipeline impact
Balances competing priorities across multiple studies and sponsors while maintaining quality and compliance
Provides guidance, training, and mentorship to study coordinators, regulatory staff, and other team members involved in start-up activities
Serves as a subject matter expert for study activation processes and best practices
Directly manages study activation staff: assigns workloads, sets performance expectations, and conducts regular performance evaluations
Other duties as assigned
Qualification
Required
Bachelor's degree required
Minimum of 3 years clinical research experience required with direct involvement in study start-up or activation
Strong knowledge of FDA regulations, GCP, ICH guidelines, and IRB processes
Excellent organizational, communication, and time-management skills
Ability to manage multiple projects simultaneously and work effectively under tight deadlines
Understanding of clinical research process and pharmaceutical development lifecycle
Mastery skills in Microsoft Word, Excel, and/or other data management tools
Understanding of clinical and site logistics, as well as study start-up and site activation
Preferred
Previous management experience preferred
Company
OneOncology
OneOncology is a partnership of oncologists and industry leading experts driving the future of community-based cancer care in the US. It is a sub-organization of General Atlantic.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Cencora
2025-12-12Acquired
2023-04-20Secondary Market
Leadership Team
Davey Daniel
Chief Medical Officer
Recent News
2026-01-05
2025-12-18
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