Clinical Lead - Site Activation Lead

Premier Research•Regional_NC, NC
•$116,000

About The Position

Premier Research is seeking a Clinical Lead - Site Activation Lead to join its Clinical Management team. The role coordinates and collaborates with functional leads to deliver site activation, organizing and overseeing strategic efforts to ensure quality and efficient delivery in line with contractual obligations. The Clinical Lead works with internal teams and sponsors, supporting study start-up strategy, site selection, activation timelines, risk management, data quality, and progress reporting.

Requirements

  • Five years of professional experience as a CL, RSM, PM, SSUA, or equivalent.
  • 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 team player able to build an effective team and comfortable participating in customer-facing meetings such as 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 is preferred.

Responsibilities

  • Coordinate and collaborate with functional leads contributing to site activation delivery, and oversee strategic efforts to ensure quality and efficient delivery according to 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 budget and start-up scope.
  • Oversee SSU and clinical activation deliveries in alignment with the project timeline 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 with 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.
  • If forecast timelines are not achieved, provide a clear rationale for delays, a contingency plan to mitigate impact, and timely escalation of issues.
  • Monitor and analyze project or program site activation status and provide metrics.
  • Provide progress updates to the internal team, client, and upper management during weekly teleconferences and as needed.

Benefits

  • Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
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