Working Location: Nationwide Workplace Flexibility: RemoteJob DescriptionThis role is responsible for the strategic and operational oversight of clinical trial activities at clinical study sites, ensuring high-quality execution, compliance, and achievement of enrollment goals.
This role serves as the primary liaison between Olympus and clinical trial sites, with a strong emphasis on proactive site engagement, communication, and performance optimization. This position leads site relationship management, drives enrollment acceleration strategies, and partners cross-functionally to identify risks and implement mitigation plans.
This role is expected to operate with a high degree of autonomy and provide leadership in site management, recruitment strategy development, and study execution, while acting as a key contributor to study success.
Job Duties- Serve as the primary point of contact and relationship owner for assigned clinical trial sites, establishing strong partnerships with investigators and site personnel through proactive communication, routine engagement, and ongoing site support.
- Lead the operational oversight of assigned clinical trial sites from qualification through close-out, including feasibility assessments, site selection, activation activities, site training, compliance oversight, and maintenance of inspection readiness.
- Develop, implement, and oversee site-specific enrollment and retention strategies, partnering with investigative sites to identify barriers, drive recruitment initiatives, share best practices, and ensure achievement of enrollment targets.
- Monitor, analyze, and report study and site performance metrics, including site activation, screening, enrollment, retention, protocol compliance, and data quality, implementing corrective and preventive actions when necessary.
- Collaborate with Data Management and investigative sites to ensure timely and accurate data entry, query resolution, eCRF completion, and overall data integrity.
- Identify, assess, and mitigate risks that may impact enrollment, timelines, data quality, patient safety, or study execution, escalating critical issues and providing clear recommendations to management and study teams.
- Partner with Clinical Project Managers and cross-functional stakeholders to support study planning, execution, performance reviews, continuous improvement initiatives, and the development of study documents, materials, and operational strategies.
- Ensure compliance with ICH-GCP, FDA regulations, ISO 14155, study protocols, and company SOPs through ongoing site oversight, documentation review, CTMS management, and maintenance of essential study records.
- Support quality and inspection-readiness activities by collaborating with Clinical Quality Assurance, participating in audit preparation and follow-up activities, and ensuring sites maintain adequate training records and study documentation.
- Serve as a subject matter expert in site management and enrollment optimization by providing mentorship, onboarding support, training, and guidance to junior team members and study staff.
Job QualificationsRequired:- BA/BS or equivalent experience required in scientific field or related healthcare disciplines.
- Minimum of 6 years of clinical research experience, including significant field monitoring experience.
- Deep knowledge of ICH-GCP, FDA, ISO 14155 regulatory frameworks and inspection readiness practices.
- Demonstrated ability to build and maintain strong site relationships and influence site performance.
- Proven experience driving site engagement, enrollment strategies, and study execution.
- Experience developing SOPs and operational frameworks.
- Demonstrated experience and competency defining and managing KPIs as well as analytical and site performance management capability.
- Excellent communication skills with the ability to effectively engage sites and cross-functional teams.
- Strong analytical and problem-solving skills with the ability to identify risks and implement solutions.
- Ability to work independently and lead initiatives in a fast-paced, cross-functional environment.
- Proficient skills with MS suite of programs and windows-based applications including Excel, PowerPoint, Project, Publisher, Word, and Visio.
- Strong ability to build and maintain positive relationships with management and peers.
- Strong leadership and cross-functional collaboration skills.
- Valid driver's license required.
- Ability to travel domestically up to 40%.
Preferred:- Certifications (e.g., ACRP, SOCRA) preferred.
- Experience in medical device clinical trials preferred.
- Experience leading or mentoring team members preferred.
- Significant experience in site management, enrollment optimization, and cross-functional collaboration preferred.
Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 24/7 Employee Assistance Program
- Free live and on-demand Wellbeing Programs
- Generous Paid Vacation and Sick Time
- Paid Parental Leave and Adoption Assistance*
- 12 Paid Holidays
- On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:- Work-life integrated culture that supports an employee centric mindset
- Offers onsite, hybrid and field work environments
- Paid volunteering and charitable donation/match programs
- Employee Resource Groups
- Dedicated Training Resources and Learning & Development Programs
- Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position is $100,263.00 - $135,355.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). This pay range represents the National Average of the range, and may vary depending on the location of the individual.
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
