Director, Clinical Project Management - US - Olympus Corporation of the Americas
Westborough, MA
About the Job
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) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
The Director, Clinical Project Management - US reports directly to the Executive Director, Clinical Operations and collaborates closely with the leadership of Clinical Affairs to lead clinical studies project management within the US region including the oversight of all aspects of clinical studies in support of clinical evidence generation strategies across global business unit portfolios.
The individual is a critical member of Clinical Operations leadership team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the global business units, and within the broader Olympus organization, as appropriate.
Job Duties
+ In collaboration with Global Clinical Operations, develop and implement a consistent and standardized approach to US Clinical Project Management, leveraging integrated project plans to ensure clinical projects are executed within scope, on-time, on-budget and with high quality.
+ Manage the US Clinical Project Management team using proactive identification of resourcing needs, screening and hiring of candidates, training on departmental responsibilities and expectations, providing mentorship and guidance, fostering a culture of continuous learning and professional development.
+ Ensure effective communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency.
+ Align with Global Clinical Leads and Clinical Operations Management to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed.
+ Identify opportunities for process improvement and develop/implement best practices to enhance the efficiency and effectiveness of clinical trial operations.
+ In close collaboration with Clinical Quality Affairs, develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations.
+ Implements a regional outsourcing strategy as required to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s).
+ Establish and oversee activities to ensure regulatory compliance across all project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools.
+ Ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
+ As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Executive Director, Clinical Operations.
+ Other duties as assigned.
Job Qualifications
Required:
+ BA/BS degree in life sciences or related field
+ Minimum of 10 years device/pharmaceutical industry experience in Clinical Affairs/Operations with direct experience in Clinical Project Management for pre and post-market trials required.
+ Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
+ 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 15%, 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:
+ MA/MS in life sciences or related field. PMP is desirable.
+ Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP)
+ Direct people management experience and managing teams. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
+ Knowledge of budget and forecasting. Experience with clinical trial agreement negotiation preferred.
+ Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
+ Strong 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.
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
+ Diversity Equity & Inclusion Initiatives including 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) .
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 .
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.
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.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at 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).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs
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) .
_Please note: All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate._
Job Description
The Director, Clinical Project Management - US reports directly to the Executive Director, Clinical Operations and collaborates closely with the leadership of Clinical Affairs to lead clinical studies project management within the US region including the oversight of all aspects of clinical studies in support of clinical evidence generation strategies across global business unit portfolios.
The individual is a critical member of Clinical Operations leadership team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across the global business units, and within the broader Olympus organization, as appropriate.
Job Duties
+ In collaboration with Global Clinical Operations, develop and implement a consistent and standardized approach to US Clinical Project Management, leveraging integrated project plans to ensure clinical projects are executed within scope, on-time, on-budget and with high quality.
+ Manage the US Clinical Project Management team using proactive identification of resourcing needs, screening and hiring of candidates, training on departmental responsibilities and expectations, providing mentorship and guidance, fostering a culture of continuous learning and professional development.
+ Ensure effective communication of study status, key performance indicators, and quality standards to ensure operational quality and efficiency.
+ Align with Global Clinical Leads and Clinical Operations Management to ensure business unit expectations are clearly defined and met, ensuring appropriate change management as needed.
+ Identify opportunities for process improvement and develop/implement best practices to enhance the efficiency and effectiveness of clinical trial operations.
+ In close collaboration with Clinical Quality Affairs, develop and maintain Standard Operating Procedures (SOPs), Work Instructions, and templates to ensure consistent management of clinical operations in compliance with applicable regulations.
+ Implements a regional outsourcing strategy as required to employ Contract Research Organizations (CROs), or other external vendors, in clinical studies and ensures management and oversight of the vendor(s).
+ Establish and oversee activities to ensure regulatory compliance across all project teams by establishing clinical research best practices, which are supported by quality procedural documents, standards, and tools.
+ Ensure clinical studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
+ As a member of the Clinical Affairs leadership team, takes ownership of the Clinical Affairs mission, objectives, and strategy over a 3- to 5-year time horizon, and is accountable to the Executive Director, Clinical Operations.
+ Other duties as assigned.
Job Qualifications
Required:
+ BA/BS degree in life sciences or related field
+ Minimum of 10 years device/pharmaceutical industry experience in Clinical Affairs/Operations with direct experience in Clinical Project Management for pre and post-market trials required.
+ Experience in overseeing clinical operations’ procedural documentation requiring a strong knowledge and application of global regulations, guidelines and standards (i.e., ICH E6 (R2), EU MDR, ISO 14155:2020) and good document management practices.
+ 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 15%, 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:
+ MA/MS in life sciences or related field. PMP is desirable.
+ Relevant professional certification (i.e., CCRC, CCRA, CCRP, PMP)
+ Direct people management experience and managing teams. Demonstrated leadership capabilities focused on hiring, nurturing, and retaining a diverse, world-class team of business professionals.
+ Knowledge of budget and forecasting. Experience with clinical trial agreement negotiation preferred.
+ Ability to think strategically, critically analyse and synthesize complicated data and scientific information.
+ Strong 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.
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
+ Diversity Equity & Inclusion Initiatives including 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) .
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 .
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.
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.
Applicants with Disabilities:**
As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at 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).
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs
Source : Olympus Corporation of the Americas
