Working Location: NATIONWIDE
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. ? ?
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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.
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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
This role is responsible for managing a clinical team and supporting the day-to-day activities associated with the execution and monitoring and trials and support of clinical procedures. This position ensures that clinical tasks and procedures are being performed in compliance with applicable regulatory standards, ICH-GCP Guidelines, and all applicable regulatory requirements and company policies and procedures.
Job Duties
Oversees and manages a clinical team of Clinical Site Managers (CSM), Clinical Research Associates (CRA), Clinical Trial Coordinators (CTC) and/or contingent employees to ensure successful execution of clinical trials and projects.
Ensures activities related to site qualification, IRB submission, site initiation, interim monitoring, site management activities, and close-out visits (performed on-site or remotely) are performed in compliance with the study-specific Clinical Monitoring Plan, Standard Operating Procedures, GCP, and applicable government regulations and guidelines.
Responsible for monitoring and trial coordination oversight including the development of monitoring schedules, key performance indicators, and status reports.
Participates in developing clinical study monitoring strategy and plans, study protocols, informed consent forms, case report forms, clinical study reports, and other key study-specific deliverables.
Provides regular updates of study progression; proactively identifies and resolves issues that arise during study conduct; manages escalation of study-related issues to the Clinical Project Manager and/or the Global Lead.
Assists in the development of appropriate standard operating procedures (SOP) and work instructions (WI) to ensure compliance with ICH-GCP guidelines and company SOPs/WIs for clinical studies.
Creates and conducts training sessions, including investigator meetings and site training.
Participates in study audits, as applicable, including providing guidance at the site and project levels towards audit readiness standards and supporting preparation for audit and required follow-up action.
Coordinates with Regulatory and Medical Safety for tracking and monitoring the reporting of Adverse Events, including conducting risk assessments/mitigation and contingency planning if required.
Provides technical and procedure support to clinical investigators and site coordinators regarding device use per IFU and trial information.
Assists the Clinical Project Manager (CPM) with tracking the progress of clinical study enrollment, milestones, and deliverables.
Acts as primary liaison with study site personnel and ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Prepares for and attends Investigator Meetings and/or sponsors face-to-face meetings.
Coordinates with data management on EDC build, UAT, and other data management activities.
Maintains excellent rapport with internal and external customers to accomplish Olympus's clinical trial goals. Serves as a key contact and advisor between the Company, CROs, clinical sites, other clinical staff and consultants to the company.
Takes ownership of the Clinical Affairs mission, and objectives.
Other duties as assigned.
Job Qualifications
Required:
BA/BS degree in life sciences or related field is a must.
Minimum 5+ years of device/pharmaceutical industry experience in Clinical Affairs/Operations.
Minimum 3+ years of direct experience with on-site monitoring.
Minimum 1+ year of people management experience required.
Experience working in a global cross-functional team (functional/matrix) environment and knowledge and/or experience working with groups with varied cultural backgrounds and learning styles is required.
Domestic and international travel up to 20%, including weekend and evening travel as needed to support business objectives and ongoing development of physician relationships.
Scheduling flexibility to commit to a global weekly schedule (Tuesday - Wednesday - Thursday) navigating multiple time zones with extended hours into the early morning as well as late evenings.
Preferred:
Strong budget and forecasting expertise. Experience with clinical trial agreement negotiation preferred.
Experience in overseeing clinical operations' procedural documentation requiring a strong knowledge and application of regional regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.
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 benefit and incentives (https://www.olympusamerica.com/careers/benefits-perks) .
The anticipated base pay range for this full-time position working at this location is $104,061.00 - $145,685.00 / 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 value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
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 OCAAccommodations@olympus.com. 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 || Research and Development
