Works closely with key internal (Marketing, R&D, Market Access, Product Development) and external stakeholders (surgeon researchers) to develop global clinical evidence generation plans to support the various needs of the business (e.g., regulatory filings, supporting claims).
Maintains relationships with Key Opinion Leaders in support of Clinical Affairs activities.
Manage assigned Investigator Initiated Study proposals, reviews, and conduct.
Supports the development of publication plans and their execution in combination with relevant internal and external resources.
Supports and helps manage creation of publication summaries and dissemination of this information.
Supports Clinical Research team, sometimes serving as the Clinical representative, interactions with regulatory authorities, notified bodies and during audits.
Supports, sometimes serves as the point person, communicating project status updates, resource needs, and other information for assigned business units and product lines.
Supports study design processes, including protocol development, while working closely with the Clinical Operations and Clinical Data Sciences teams.
Requirements
Bachelor’s degree required; in a health sciences; preference for degrees in biological sciences, engineering, or related medical/scientific field preferred.
6+ years’ experience directly supporting clinical device research or similar experience in a medical device scientific area.
Understanding of industry clinical research regulations and best practices (e.g., ISO 14155, ICH GCP).
Preferred Excellent interpersonal skills and the ability to work well independently as well as with co-workers, peers, supervisors, and external customers.
High attention to detail and accuracy.
Benefits
USD Annual salary plus bonus eligible + benefits
Applicant Tracking System Keywords
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