Clinical Lead - Site Activation Lead

11 Premier Research International LLC; North Carolina; Vor Ort; USD 104.000 - 128.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement plans

Paid time off

Zusammenfassung

Premier Research is seeking a Clinical Lead - Site Activation Lead to join our Clinical Management team in delivering site activation strategies for biotech, medtech, and specialty pharma projects. The role focuses on coordinating cross-functional efforts, ensuring quality and timely delivery, and guiding kick-off meetings while managing timelines and budgets.

The ideal candidate has 5+ years in CL/RSM/PM roles, strong leadership, and solid ICH/GCP knowledge.

Qualifikationen

• Undergraduate degree or international equivalent in clinical, science, or a health-related field from an accredited institution or a licensed health-care professional is preferred.
• 5 years professional experience as a CL, RSM, PM, or SSUA or other equivalent experience.
• Demonstrated ability in leading a team in study start-up and across other functions.
• Understands financial aspects of the project and ensures adherence to timelines and study budget.
• Excellent interpersonal skills and a strong team player, comfortable in customer-facing meetings like Bid Defense Meetings.
• Strong knowledge of ICH / GCP regulations.

Aufgaben

• Coordinates 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.
• Leads Site ID Kick Off Meeting and attends relevant internal and external kick-off meetings.
• Reviews study budget and start-up scope; Oversees SSU and clinical activation deliveries in alignment with the project timeline/strategy.
• Monitors and analyzes project/site activation status and provides metrics and updates to internal team and sponsor.

Kenntnisse

Leadership

Financial acumen

Interpersonal skills

Team player

Time management

Ausbildung

Undergraduate degree

Jobbeschreibung

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.

What you'll be doing:

• Coordinates 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.
• Leads Site ID Kick Off Meeting.
• Attends relevant internal and external kick-off meetings.
• Understands client objectives, timelines and study start-up strategy.
• Reviews study budget and start-up scope.
• Oversees SSU and clinical activation deliveries in alignment with the project timeline/strategy.
• Updates Premier Predict/ Study projections through site activation.
• Works with Project Strategist, Medical Informatics, Medical Affairs, PM, RSMs, CLs and SSU Country Leads to finalize countries mix and site selection.
• Escalates and tracks risks to PM and Sponsor, identifying mitigation strategies.
• Uses data to drive decisions, next steps, and enhance team communication.
• Proposes proactive solutions to address risks or issues impacting delivery of site activations.
• Oversees and supports CTMS data entry through site activation to ensure data quality.
• If forecasted timelines are not achieved, provides clear rationale for delays, contingency plan to mitigate impact, and escalates issues as soon as identified.
• 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.

What we're looking for:

• Undergraduate degree or its international equivalent in clinical, science, or a health-related field from and accredited institution or a licensed health-care professional is preferred.
• 5 years professional experience as a CL, RSM, PM, or SSUA or other equivalent experience.
• Demonstrated ability in the leadership of a team of individuals in study start-up and across other functions.
• Understands financial aspects of the project and ensures adherence to project timelines and study budget.
• Excellent interpersonal skills and strong team player, collaborative and able to build an effective team and comfortable in customer-facing meetings like Bid Defense Meetings.
• Excellent organizational, time-management, presentation, technical, and written/verbal communication skills.
• Strong knowledge of ICH / GCP regulations.

Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $116,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Premier Research is more than a company - it is a community furthering research to improve the lives of patients in critical need. We are a diverse staff thinking creatively, challenging ideas, and solving complex problems.

Our Values - We Aim High, We Work Together, We Stay Agile, We Get It Done, We Care - mirror the determination, flexibility and trust that our team embodies.

As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning. Premier Research is a global clinical research, product development, and consulting company. We are dedicated to helping biotech, specialty pharma, and MedTech innovators transform life-changing ideas and breakthrough science into new medical treatments. Our team is inspired by this common purpose. Premier is a place where you can change lives, and feel rewarded and celebrated. We aim high - we will not stop until we reach our goals. And we care about each other, about our customer and partners, and most importantly, about all the patients that we touch with our work.