Manager, Clinical Research Study Activation

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

The Manager, Clinical Research Study Activation is responsible for overseeing and optimizing the end-to-end study activation process for oncology clinical trials, from feasibility through site initiation and activation. This role ensures studies are activated efficiently, compliantly, and in alignment with institutional priorities, sponsor timelines, and resource capacity. The Study Activation Manager serves as a central leader and subject matter expert for study start-up activities, providing strategic oversight, process standardization, and staff leadership while partnering closely with investigators, regulatory teams, budgets and contracts, research operations, and sponsors/CROs.

ESSENTIAL FUNCTIONS:

• 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.

EDUCATION AND EXPERIENCE

• Bachelor’s degree required.
• Minimum of 3 years clinical research experience required with direct involvement in study start-up or activation.
• Previous management experience preferred.
• 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.