Clinical Lead - Site Activation Lead

Premier Research•Regional_NC, NC

About The Position

Premier Research is looking for a Clinical Lead - Site Activation Lead to join our Clinical Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

Requirements

Bachelor’s degree, or its international equivalent from an accredited institution, in a clinical, biological, scientific, or health-related field; or equivalent work experience
5 years prior clinical research experience in a Clinical Lead, Regulatory Submission Lead, Project Manager, or Study Start Up role or other equivalent experience required
Excellent communication, presentation and soft skills to manage teams and sites effectively.
Ability to be accountable, dependable and demonstrate commitment

Nice To Haves

Travel may be required up to 20%

Responsibilities

Coordinates work and oversees timelines and quality//deliverables of individual contributors (SSU/CRAs, Analyst) and collaborates with functional leads contributing to the delivery of site activation.
Organizes/oversees strategic efforts to drive quality and efficient delivery of site activations per contractual obligations.
Presents relevant internal and external kick-off meetings to ensure a strong and aligned SSU and clinical activation strategy and the proposed study budget aligns with execution expectations of the customer.
Understands client objectives, timelines and study start-up strategy.
Reviews study budget and start-up scope.
Communicates with PM and sponsor to ensure close control of vendor’s documentation required for SSU submissions.
Follows up until delivered.
Meets weekly with Site ID, regulatory, contracts, and clinical leads to check on prioritization, timelines, targets per month, changes of scope and risks.
Monitors and analyzes project/program site activation status and provides metrics.
Provides progress updates to internal team, client, and upper management during weekly teleconferences and as needed.