Senior Clinical Research Scientist (Gastrointestinal Solutions-GIS)

Job Description

This role collaborates closely with the leadership of Clinical Affairs to execute clinical research strategy activities and oversee aspects of clinical trials in support of clinical evidence generation strategies across the GIS - Gastrointestinal Solutions Division; GI (including core GI, EUS, and Infection Prevention), EndoTherapy, Medical Service, and Endoscopic Solutions Ecosystem.

This individual will participate in the development, execution, and closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus’s portfolio. Specifically, this individual will be responsible for writing clinical study protocols, case report forms, and study reports; will work closely with study sites to obtain necessary approvals (EC/IRB); and will respond critically to questions raised throughout the clinical study execution.

The individual is a critical member of Clinical Affairs strategy team and collaborates with cross-functional teams including internal and external business stakeholders within MSA, across different business units, and within the broader Olympus organization, as appropriate. 

Job Duties

• 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.

Job Qualifications

Required:

• 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.
• 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