Clinical Research Scientist

Location: Center Valley

** Working

Location:

Nationwide*
* ** Workplace Flexibility:
Remote*
* ** _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:
.

** Job Description*
* This role collaborates closely with the leadership of Clinical Affairs to assist in the development and execution of clinical strategy activities and clinical studies in support of clinical evidence generation strategies across the  
** Gastrointestinal Solutions Division
** business unit portfolios.  
** This role focuses on clinical evidence generation and trial strategy rather than laboratory experimentation, bench research, or wet-lab activities**  **.*
* ** We are only considering candidates located in the continental United States (North America) with a preference for candidates located in the East Coast time zone.*
* This individual assists 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, provides support to the execution of evidence generation strategy that will drive the clinical evidence strategy for  
** Gastrointestinal Solutions Division
** business unit.

+ 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.

+ Ensures clinical 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. Advanced degree in life sciences, medicine or related field highly preferred.

+ Minimum of 5 medical device industry experience post-degree preferably in Clinical Affairs/Operations, Medical Affairs within biotech industry.

+  
** Experience translating marketing and commercial needs into clinical research and evidence-generation strategies and clinical trial design.*
* + 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 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…