Senior Manager, Site Start Up Lead; Hybrid

Remote, USOpportunity Details

KPS Life is hiring a Senior Manager, Global Site Start-Up Lead (SSU Lead) to be fully dedicated to our sponsor client and based remotely.

We are seeking an experienced site start-up leader with at least 8 years of industry experience and proven expertise in driving global site activation for complex, high-profile clinical trials. The ideal candidate will have strong skills in developing site activation strategies, managing CRO performance, leading line management responsibilities, and leveraging data-driven insights to accelerate study start-up while maintaining inspection readiness.

The Senior Manager, Global Site Start-Up Lead (SSU Lead) is responsible for driving the global execution of site activation for complex, high profile clinical trials, performing the role with a high degree of independence to ensure efficient and compliant processes aligned with sponsor SOPs, ICH-GCP guidelines, and industry standards. Partnering closely with cross-functional teams and Clinical Research Organizations (CROs), this role balances strategic oversight with hands‑on leadership to address challenges and deliver study objectives.

The SSU Lead develops site activation projections, mitigates risks impacting site activation, and monitors CRO performance by analyzing metrics. Additionally, they lead all aspects of site start-up activities, including fast-track initiation, milestone tracking, and document collection, while ensuring timely submissions and leveraging country intelligence for informed decision‑making. This person will also be responsible for direct line management and supporting development of their team.

• Develop the site start-up strategy for each study assigned (complex, high profile), outlining all dependencies impacting site activation and actively mitigating and escalating risks.
• Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions.
• Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making.
• Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives.
• Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness.

• Partner with cross-functional and CRO partners (where applicable) to develop a comprehensive global country start-up strategy, outlining all dependencies impacting country start-up and actively mitigating and escalating risks cross-functionally.
• Monitor and maintain country intelligence data to support informed decision-making and develop accurate startup projections and strategic plans.
• Support regulatory submissions as needed, including activities such as providing required site documentation, coordinating submissions to Central Institutional Review Boards (CIRBs), supporting sites with Local Institutional Review Board (LIRB) submissions, and handling or supervising Clinical Research Organization (CRO) insurance requests.
• Ensure timely country submission deliverables (ensure task completion; all roles clarity, identification of critical path items, effective communication pathway).

• Lead and oversee all aspects of site start-up activities for complex, high profile studies, including fast-track site initiation, site calls, document collection, and milestone tracking, ensuring timely and efficient completion of processes.
• Serve as the subject matter expert for essential site documents, providing training, guidance, and support to teams…