Senior Clinical Site Manager

Olympus America, Inc.; Center Valley, Westborough (Lehigh County, MA); Hybrid; USD 100.000 - 135.000; Vollzeit

Benefits dieser Stelle

Competitive salaries

Annual bonus

401(k) with company match

Employee Assistance Program

Wellbeing programs

Paid vacation

Parental leave

Paid holidays

On-site daycare

Fitness center

Volunteer programs

Zusammenfassung

Olympus America, Inc. is seeking a clinically focused Site Management professional to oversee trial activities at study sites, ensuring enrollment targets, data quality, and regulatory compliance. You will act as the liaison between Olympus and sites, driving engagement and performance improvements across multiple studies.

The role requires strong leadership, independent operation, and travel up to 40%. A BA/BS and 6+ years in clinical research are expected, with experience in SOP development

Qualifikationen

• BA/BS or equivalent in a scientific field or related healthcare discipline.
• Minimum of 6 years clinical research experience, including significant field monitoring.
• Deep knowledge of ICH-GCP, FDA, ISO 14155 regulatory frameworks and inspection readiness.
• Proven ability to build and maintain strong site relationships and influence site performance.
• Experience driving site engagement, enrollment strategies, and study execution.
• Experience developing SOPs and operational frameworks.
• Proficient in MS Office and data analysis; strong communication with cross-functional teams.
• Ability to travel domestically up to 40%.

Aufgaben

• Serve as the primary point of contact and relationship owner for assigned clinical trial sites.
• Lead operational oversight from qualification to close-out, including feasibility and activation.
• Develop and oversee site-specific enrollment and retention strategies.
• Monitor and report site performance metrics and implement corrective actions.
• Collaborate with Data Management to ensure data quality and timely entry.
• Identify and mitigate enrollment and data risks; escalate issues as needed.
• Support study planning with cross-functional teams and study documents.
• Ensure compliance with ICH-GCP, FDA, ISO 14155, and SOPs.

Kenntnisse

Site relationships

Enrollment strategies

Data management

Communication

Problem solving

MS Office

Travel 40%

Ausbildung

BA/BS or equivalent experience

Tools

MS Office

Excel

PowerPoint

Project

Publisher

Word

Visio

Windows

Jobbeschreibung

For more than 100 years,Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy,True to Life, by advancing medical technologies and elevating the standard ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

This 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 Qualifications

Required:

• 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.

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
• 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

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 representsthe 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.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

Applicants Requesting Accommodations:Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Let’s realize your potential, together.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.