Clinical Research Manager Position Overview:
* Develop and manage clinical research projects to ensure compliance with regulatory protocols.
* Lead cross-functional teams in project planning, execution, and closure.
* Create and approve study-specific documents, tools, and presentations.
* Maintain Trial Master Files and Investigator Site Files for multiple studies.
* Present at Investigator meetings.
* Evaluate sites, initiate, and close studies.
* Manage medical device tracking and accountability.
* Develop and maintain study databases, track, and report progress.
* Generate study reports and provide clinical insights for regulatory submissions.
* Perform or delegate monitoring and site visits.
* Serve as liaison between clinical sites, CROs, SMOs, and vendors.
* Stay up-to-date on regulatory requirements and industry literature.
* Perform other clinical duties as required.
Requirements and Qualifications:
* Bachelor's degree in a relevant scientific discipline.
* 5-8 years of experience in the medical device industry, specifically in clinical studies.
* Pre-market and post-market clinical studies experience is essential.
* Clinical certifications are desirable.
* Thorough understanding of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR regulations.
* Demonstrated ability to manage critical projects within interdisciplinary teams.
* Excellent problem-solving and communication skills.
* Self-motivated, highly organized, and detail-oriented individual.