Program Manager, Global Investigator Initiated Trials Job in Pennsylvania

Job title: Program Manager, Global Investigator Initiated Trials

Company: Olympus

Expected salary:

Location: Center Valley, PA

Program Manager, Global Investigator Initiated Trials Job Details:

Working Location: PENNSYLVANIA, CENTER VALLEY; MASSACHUSETTS, WESTBOROUGH; MINNESOTA, BROOKLYN PARK; Nationwide

Workplace Flexibility: Field

Are you looking for a company that cares about people’s lives and health, including yours? Let’s inspire healthier lives, together.

Olympus, a leading medical technology company, has focused on making people’s lives better for over 100 years.

Our Purpose is to make people’s lives healthier, safer, and more fulfilling.

Our Core Values are reflected in all we do: Integrity – Empathy – Agility – Unity – Long-Term View

We deliver on our purpose and our core values by staying True to Life.

Job Description

The Program Manager, Global Investigator Initiated Trials (IIT) reports directly to (TBD) and collaborates closely with the Global and Regional Leads of Clinical Affairs and regional IIT Administrators – and will be primarily responsible for managing, implementing, and maintaining oversight of all administrative aspects of the global Investigator Initiated Trial (IIT) program.

Job Duties

• Manage, organize, and monitor the Global Olympus IIT Program. Decide on appropriate strategies and objectives in collaboration with Global Clinical and Medical leaders.
• Establish and optimize processes and procedures to ensure effective cross-functional communication and program adherence with Olympus scientific objectives and research priorities. Lead process improvement activities as needed.
• Provide program management for the Global IIT Review Board Meetings and utilize the IIT Portal accordingly.
• Act as the global program leader and contact person for all regions, CPMs and Global IIT Review Board members as far as the Olympus IIT program is affected.
• Coordinate the development and manage the IIT strategy and development of Global Areas of Interest lists to support IIT prioritization. Support evidence generation strategies.
• Oversee and uphold standard for the IIT program ensuring process adherence to Olympus policies, procedures, and work-instructions.
• Serve as owner and subject matter expert for the Olympus IIT Portal including opening and resolving tickets with external vendor, establishing and managing user profiles, and maintaining user guides and training materials.
• Implement and monitor process rigor including acceptance criteria, fair market value assessment, and adherence to applicable board requirements (compliance, business, quality metrics).
• As appropriate, liaise between investigators, regional cross-functional partners, and global cross- functional partners, including the regional IIT administrative staff throughout study process from submission to completion.
• In collaboration with applicable regional IIT administrators and HCP-CM, support the contracting process and coordination of supply planning including regional logistics of importing/ordering with cross-functional collaborators as appropriate.

Job Qualifications

Required:

• BA/BS Degree in life sciences, or related field or combination of other BA/BS and minimum of 5 years of relevant medical device/life sciences/pharmaceutical industry experience.
• Minimum of 8 years previous experience with medical device trials, serving as a clinical study coordinator, or site manager.
• Minimum of 10 years previous experience with program and project management; global experience strongly preferred.
• Minimum of 6 Previous experience overseeing IIT programs.
• Working knowledge of ICH Good Clinical Practice guidelines
• Working knowledge of fraud and abuse laws and regulations applicable to the medical device and/or pharmaceutical industries.
• 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.
• Ability to travel up to 10%.

Preferred:

• Strong computer skills with proficiency with MS Windows-based applications.
• Strong organizational skills with attention to details.
• Ability to build and maintain positive relationships with management and peers.
• Ability to work independently and manage multiple tasks in a fast-paced environment.
• Ability to work effectively on cross-functional teams.
• Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.
• Excellent written and verbal communication skills, including the ability to communicate effectively at all levels of the organization.

#LI-Hybrid

Why join Olympus?

Here, people matter-our health, our happiness, and our lives.

• Competitive salaries, annual bonus and 401(k)* with company match
• Comprehensive Medical, Dental, Visions coverage effective on start date
• 24/7 Employee Assistance Program
• Free virtual live and on-demand wellness classes
• Work-life balance supportive culture with hybrid and remote roles
• 12 Paid Holidays
• Educational Assistance
• Parental Leave and Adoption Assistance
• Volunteering and charitable donation match programs
• Diversity & Inclusion Programs including Colleague Affinity Networks
• On-Site Child Daycare, Café, Fitness Center**

*US Only

**Limited locations

We care about your health and financial well-being and offer the resources you need to feel vital, confident and ready for wherever life takes you. Learn more about our benefit offerings at .

About us:

Our Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce costs, and enhance the quality of life for patients and their safety.

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 .

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

Olympus requires all US new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

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 ||
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