Senior Clinical Site Identification and Start-Up Manager (Remote)

RTI International (RTI) is both a global research institute and a leading international development organization based out of North Carolina. At RTI, you will find work you believe in, tackling some of the most complex global challenges of our time. Our mission is to impact the wellbeing of 1 billion people by 2030 through science-based solutions in climate, education, health, and equity. Our staff promote meaningful change around the world helping people live healthier, more productive, and more independent lives.

If you are looking for an opportunity to make a real difference, RTI is the place for you. Join us in our commitment to teamwork, belonging, and the passion to change the world.

We are seeking a Senior Clinical Site Identification and Start-Up Manager to lead and manage the site identification, feasibility assessment, and site start-up activities for clinical trials. This senior-level position will be responsible for overseeing the timely initiation of clinical trial sites, collaborating with cross-functional teams, and ensuring the highest standards of compliance and quality. The ideal candidate will bring extensive experience in clinical trial site management, including strategic planning, vendor management, and problem-solving, as well as a proven track record of driving efficiencies in the start-up phase of clinical trials.

Please note, this position manages the study, but does not have administrative management responsibilities for any staff.

Site Identification and Feasibility Strategy:

• Lead the site identification and feasibility process, ensuring the selection of qualified clinical trial sites that meet study-specific requirements, patient recruitment goals, and operational capacity.
• Develop and implement strategies for identifying high-performing sites across various therapeutic areas, building and maintaining a strong network of investigational sites globally.
• Collaborate with internal stakeholders (e.g., clinical operations, regulatory affairs, project management) to determine the ideal sites for each study based on key factors such as study objectives, timelines, and patient population.

Site Start-Up Leadership:

• Oversee all aspects of the site start-up process, including site selection, contract negotiation, IRB/IEC submissions, regulatory document collection, and site initiation visits (SIV).
• Lead the development and execution of site start-up timelines and ensure milestones are met to ensure timely study initiation.
• Work closely with the project management and clinical operations teams to ensure proper site documentation, approval processes, and start-up deliverables are achieved.

Cross-Functional Collaboration:

• Act as a key liaison between sites, clinical operations teams, regulatory teams, and external stakeholders, ensuring smooth communication and coordination throughout the site start-up phase.
• Provide guidance and mentorship to junior team members and cross-functional colleagues to ensure best practices in site identification and start-up processes are followed.
• Collaborate with senior leadership to ensure alignment on site selection criteria, timelines, and project goals.

Process Optimization and Continuous Improvement:

• Lead initiatives to improve the efficiency and effectiveness of site identification and start-up processes through continuous process optimization and use of innovative tools.
• Monitor key performance indicators (KPIs) for site start-up and identify areas for improvement to streamline operations, reduce delays, and enhance site performance.
• Proactively identify and mitigate risks to timely site initiation, including addressing potential roadblocks related to contracts, regulatory approvals, and site capacity.

Risk Management and Issue Resolution:

• Oversee the resolution of complex issues that arise during site start-up, including regulatory hurdles, contract negotiations, and investigator/site performance challenges.
• Implement strategies to proactively mitigate risks at the site level and ensure regulatory compliance and trial integrity.
• Escalate critical issues to senior management when necessary and provide solutions to overcome challenges in site activation.

Vendor and Site Relationship Management:

• Build and maintain strong relationships with external vendors, investigative sites, and site personnel, fostering a collaborative and supportive environment throughout the start-up process.
• Lead vendor selection for site start-up activities and manage vendor performance to ensure compliance with timelines and budget.
• Conduct regular performance evaluations of sites, ensuring site staff are adequately trained and supported for successful trial execution.

Compliance and Documentation Management:

• Ensure that all regulatory documents, contracts, and essential documents are accurately completed, maintained, and filed in compliance with applicable regulations (e.g., GCP, ICH, FDA, EMA).
• Ensure that study-specific documentation is prepared for regulatory and sponsor review, and that all submissions are completed on time.
• Oversee the preparation of site start-up reports and presentations for senior management, highlighting key milestones, risks, and progress.

Training and Development:

• Provide training to internal teams on site start-up best practices and regulatory requirements, ensuring consistent and high-quality execution across studies.
• Mentor and guide junior staff and colleagues involved in the site identification and start-up process to enhance their skills and professional development.
• Stay informed about industry trends, new regulations, and best practices to maintain expertise in clinical trial site management.

• Bachelor's Degree and 10 years of experience, Master's degree and 8 years of experience, PhD and 6 years of experience, or equivalent combination of education and experience.
• Relevant clinical research certifications (e.g., CCRA, CCRP) preferred but not required.
• A minimum of 5 years of experience in clinical trials with experience specifically in clinical site identification, start-up, and management.
• Proven experience managing site start-up for Phase I-IV clinical trials across multiple therapeutic areas.
• Knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and experience navigating complex regulatory and ethical processes for clinical trial start-up.
• Prior experience managing or leading a team and providing mentorship and training to junior colleagues is highly desired.
• Strong understanding of clinical trial management processes, including site identification, contract negotiation, regulatory submissions, and study initiation.
• Excellent project management and organizational skills, with the ability to prioritize tasks and manage multiple sites across various stages of the start-up process.
• Strong communication, negotiation, and interpersonal skills with the ability to build relationships with internal and external stakeholders.
• Proficient with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software tools.

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For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.

RTI accepts applications to our job openings from candidates with criminal histories or conviction records in accordance with all applicable laws, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For Applicants in Massachusetts Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States. RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.

At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.