Clinical Research Manager Job in Menlo Park, California US
Acclarent, Inc., a member of the JJ Family of Companies is actively recruiting for a Clinical Research Manager to be located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT surgeons and their patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty devices. Through the Balloon Sinuplasty technology and our Relieva product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were initially completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT.
The Clinical Manager will support pre- and post-market clinical studies worldwide and other clinical projects.
Responsibilities include management of overall operations of clinical studies including design, planning, budgeting and resource management to support regulatory submissions and scientific publications. This position will be responsible for trial conduct, study tracking, trial process development and management of vendors. The Clinical Manager will contribute to clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions, site initiation activities, data collection, clinical monitoring, interpretation of clinical data, scheduling and coordination of study activities with investigational sites, clinical trial reporting, and other clinical activities.
This position will also serve as the clinical representative on one or more product development teams and will be responsible for conducting risk analysis documentation for specific projects. The Clinical Manager will be expected to become an expert in both Acclarent's body of supporting evidence as well as the relevant sinus surgery literature. Providing clinical review of advertising and promotion claims and materials may also be required.
Qualifications
A minimum of a Bachelor's degree is required. An RN or RT is a plus. A minimum of 8 years of experience in clinical research, clinical operations, as a clinical associate/specialist or relevant experience is required. Medical device industry experience is required. Knowledge and experience in planning and executing device pre- and/or post-market clinical studies is required. This position will interface with opinion leaders in the field of ENT and must be capable of representing the company in a professional and appropriate manner required. Specific experience in interfacing with ENT specialists is preferred. A basic understanding of sinus disease and treatments is preferred. Experience with medical writing is a plus. Competency with interpretation of clinical data/professional literature and statistical analysis required. Thorough knowledge of Good Clinical Practice (GCP), FDA, CFR and local regulations is required. Applicant must have excellent verbal and written communication skills. Applicant must be detail-oriented, work well with cross-functional teams, exhibit initiative and be passionate about their job. Applicant should be motivated and a self-starter who can work independently once projects have been assigned. This position requires 25% - 40% travel in the US and worldwide.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson Johnson Family of Companies.