Senior Clinical Trials Coordinator

Working Location: Massachusetts, Westborough; Minnesota, Brooklyn Park; Pennsylvania, Center Valley

Workplace Flexibility: Hybrid

_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 of patient 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.

Learn more about Life at Olympus: https://www.olympusamerica.com/careers .

Job Description

The Senior Clinical Trial Coordinator (SCTC) is responsible for the coordination and administration of clinical trials under the direction of the Dir. Clinical Projects. The SCTC will develop, implement, and coordinate study and administrative procedures for the successful management of clinical trials. The SCTC will perform diverse administrative duties requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study specific protocols. The SCTC will take on additional leadership responsibilities including onboarding, training, and mentorship of more junior Clinical Affairs team members. The SCTC will help organize responsibilities for more junior Clinical Affairs team members working directly with the Dir. Clinical Projects.

Job Duties

• Coordinates and supports activities for multiple studies under the direction of the Dir. Clinical Projects.

• Assists Clinical Affairs team with development of study specific documents.

• Responsible for set-up, maintenance, and archival of the Trial Master File (TMF).

• Collects and tracks regulatory documents for multiple studies to ensure completeness of TMF and audit readiness.

• Supports drafting of Clinical Trial Agreement (CTA), budget, and requests study specific Confidential Disclosure Agreements (CDA).

• Creates study specific Regulatory Binder and ships to clinical sites.

• Manages all aspects of study specific payments (e.g. vendors, sites) in accordance with executed agreements and approved budgets.

• Tracks payments and expenses against the department’s budget and regularly interfaces with Finance Department on study accruals.

• Communicates with principal investigators, hospital research, and legal staff to coordinate execution of a study.

• Provides support for study specific meetings (e.g. investigator, core teams, data safety monitoring board (DSMB)), drafts and circulates meeting minutes.

• Assists in remote and/or on site study monitoring.

• Assists Clinical Affairs team with site training (e.g. onsite or remote) to electronic data capture (EDC) system or protocol as needed.

• Designs and updates study specific newsletters and circulates final document to sites.

• Responsible for study device/equipment shipments, accountability, and reconciliation.

• Maintains Sunshine Act reporting records for assigned studies and reports updates to the Olympus Transparency Reporting team as needed.

• Ensures compliance to applicable clinical study regulations and Olympus SOPs, WIs, and policies.

Job Qualifications

Required:

• Minimum of 1 year of experience working for a medical device, biotech, or pharmaceutical company.

• Ability to support multiple projects for Olympus Clinical Affairs teams at different locations.

• Well organized, detail oriented, and accountable.

• Strong written, oral, and interpersonal communication skills.

• Flexible, self-motivated, and works well under pressure in a dynamic environment.

• Proficiency with Microsoft Office and electronic data capture (EDC) systems.

• MS Word.

• MS Excel.

• MS Outlook.

• MS PowerPoint.

• Ability to travel up to 10% of the time.

Preferred:

• Associate’s or Bachelor’s degree in a scientific, healthcare, or business-related field is preferred.

• Experience working for a medical device, biotech, or pharmaceutical company in a Medical Affairs-related function, preferably.

• Some experience organizing and analyzing data 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 in this location is $59,549.00 - $80,390.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).

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. We warmly encourage all who wish to bring their talents to Olympus to apply.

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 [email protected]. 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.

Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs