Clinical Lead - Senior Site Activation Lead

Premier Research Group; Raleigh (NC); On-site; USD 104,000 - 128,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

Job summary

Premier Research is seeking a Clinical Lead - Senior Site Activation Lead in Raleigh, NC to drive site activation for biotech, medtech and specialty pharma studies. You will coordinate cross-functional teams, align objectives, timelines, and budgets to ensure successful start-up.

You will lead kick-off meetings, oversee SSU and activation delivery, monitor risks, and maintain CTMS data quality. A leadership mindset, strong communication, and ICH/GCP knowledge are essential for success.

Qualifications

• Undergraduate degree in a clinical, science, or health-related field.
• At least 5 years of professional experience in CL/RSM/PM or equivalent.
• Proven leadership of a study start-up team and cross-functional collaboration.
• Strong financial acumen and ability to manage budgets and timelines.
• Excellent interpersonal, organizational, and communication skills.
• Strong knowledge of ICH/GCP regulations.

Responsibilities

• Coordinate and lead site activation with cross-functional teams.
• Lead Site ID Kick Off Meetings and align with objectives and budgets.
• Oversee SSU and activation deliveries per timeline and projections.
• Collaborate to finalize country mix and site selection.
• Escalate risks, propose mitigations, and drive data-driven decisions.
• Ensure CTMS data entry quality through activation.

Skills

Leadership

Cross-functional collaboration

Communication

Time management

ICH/GCP knowledge

Education

Bachelor's degree in clinical, science, or health-related field

Job description

Premier Research is looking for a Clinical Lead - Senior 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.