Note: The job is a remote job and is open to candidates in USA. Olympus Corporation is a global medical technology company dedicated to enhancing people's lives through innovative solutions. They are seeking a Senior Clinical Research Scientist to collaborate with Clinical Affairs leadership, execute clinical research strategies, and oversee clinical trials within the Gastrointestinal Solutions Division. The role involves developing clinical study protocols, managing trial execution, and ensuring compliance with regulatory standards.
Responsibilities
- In collaboration with internal and external to MSA stakeholders, contribute to an evidence generation strategy that will drive the clinical evidence strategy for Olympus business units
- Provides critical input into Business Development, R&D, and product development project (PDP) activities to inform decision-making on whether clinical evidence supports a product’s value proposition
- Participates in strategic and operating planning activities in partnership with the Global Clinical Leads, in translating corporate and divisional initiatives into operational plans
- Participate in clinical trial design (protocol and CRF development), execution (data collection, analysis, and interpretation), and closeout (final reporting)
- Oversee execution of Investigator Initiated Trials (IIT) and Collaborative Clinical Research (CCR) initiatives
- Present clinical study updates to internal and external stakeholders; support Publication strategies
- Support Regulatory submissions
- Facilitate cross-functional communication between Sales and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs, and investigational sites
- Ensures clinical research studies are conducted in compliance with relevant Olympus policies, procedures, regional and local regulatory requirements, and global guidelines and standards
- Other duties as assigned
Skills
- BA/BS degree in life sciences or related field
- Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within medical device industry
- Experience working on clinical research evidence generation strategies
- Ability to think strategically, critically analyse and synthesize complicated data and scientific information
- Demonstrated scientific writing ability
- Ability to plan and organize project assignments of substantial variety and complexity
- Ability to be innovative, resourceful, and work with minimal direction
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Demonstrated ability to engage with external stakeholders; build and maintain relationships with key opinion leaders, investigators, and research staff
- Strong organizational and follow-up skills, as well as attention to detail
- Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration
- 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 5-10%, 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
- Advanced degree in life sciences, medicine or related field
- Clinical research study design in the field of endoscopic therapy or minimally invasive medical technologies
Benefits
- 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
- 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
Company Overview
Olympus is passionate about creating customer-driven solutions for the medical industry. It was founded in 1919, and is headquartered in Shinjuku, Yamanashi, JPN, with a workforce of 10001+ employees. Its website is https://heylink.me/yokubet.id/.