Clinical Lead - Senior Site Activation Lead

Premier Research•Regional_NC, NC

9h•$116,000

About The Position

Premier Research is seeking a Clinical Lead - Senior Site Activation Lead to join its Clinical Management team. The role supports biotech, medtech, and specialty pharma companies in developing medicines, devices, and diagnostics, with a focus on coordinating and overseeing quality, efficient site activation delivery in accordance with contractual obligations, study strategy, timelines, and budgets. The Clinical Lead collaborates with functional leads and cross-functional teams to plan and monitor site activation, oversee study start-up and clinical activation activities, manage risks, ensure CTMS data quality, and communicate progress to internal teams, clients, and upper management. The position requires leadership experience in study start-up, knowledge of project financials and ICH/GCP regulations, and the ability to work collaboratively in customer-facing settings.

Requirements

Five years of professional experience as a CL, RSM, PM, SSUA, or in other equivalent experience.
Demonstrated ability to lead a team in study start-up and across other functions.
Understanding of project financial aspects and ability to ensure adherence to project timelines and study budget.
Excellent interpersonal skills; collaborative approach and ability to build an effective team.
Comfort in customer-facing meetings, including Bid Defense Meetings.
Excellent organizational, time-management, presentation, technical, and written and verbal communication skills.
Strong knowledge of ICH/GCP regulations.

Nice To Haves

Undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution, or licensure as a health-care professional.

Responsibilities

Coordinate and collaborate with functional leads contributing to site activation delivery, organizing and overseeing strategic efforts to ensure quality and efficiency in accordance with contractual obligations.
Lead the Site ID Kick Off Meeting and attend relevant internal and external kick-off meetings.
Understand client objectives, timelines, and study start-up strategy; review study budgets and start-up scope.
Oversee SSU and clinical activation delivery in alignment with project timelines and strategy.
Update Premier Predict and study projections through site activation.
Collaborate with the Project Strategist, Medical Informatics, Medical Affairs, PM, RSMs, CLs, and SSU Country Leads to finalize country mix and site selection.
Escalate and track risks to the PM and Sponsor, identify mitigation strategies, use data to guide decisions and communication, and propose proactive solutions to delivery risks or issues.
Oversee and support CTMS data entry through site activation to ensure data quality.
When forecast timelines are not achieved, provide a rationale for delays, a contingency plan to mitigate impact, and timely escalation of issues.
Monitor and analyze project/program site activation status and provide metrics.
Provide progress updates to the internal team, client, and upper management during weekly teleconferences and as needed.