Clinical Research Manager
Reports into: Clinical Research Director
Company: OrbusNeich Medical, Inc.
Location: Ft. Lauderdale, FL
Company Overview
OrbusNeich Medical, Inc., located in Ft. Lauderdale, Florida, is an employee-oriented medical device company dedicated to developing and commercializing minimally invasive medical devices for the treatment of vascular disease.
Job Description
The Clinical Research Manager is responsible for the correct, effective and efficient planning, coordination and execution of ongoing and new clinical projects.
The Clinical Research Manager is required to perform the following duties:
Overall Project management.
Manage assigned clinical research activities from study planning to final reports.
Development of study related documents including but not limited to protocol, CRFs, trial masters, etc.
Conduct site initiation, monitoring and close out visits, as needed.
Maintain relationship with internal and external customers.
Forecast product requirements for clinical trials, manages inventory, complaint handling and returns.
On going Management of vendor activities including audit, budget and contract negotiations.
The qualified candidate will possess the following:
Minimum of Five years of clinical research experience (industry, CRO, academic, or clinical) preferably in the area of medical devices and/or cardiovascular medicine.
Minimum of a Bachelors degree, preferably in a scientific discipline.
Strong project management skills and demonstrated success in management of clinical trials and CRO activities.
Knowledge of US regulations and standards related to medical devices and clinical research.
Strong communication skills, Ability to travel up to 30-50% of the time as needed.
Fluent in English (verbal and written).
Please attach a copy of your resume (preferably in a Word document), cover letter and
Salary history via e-mail to: Employment.us@orbusneich.com.
