Clinical Trial Manager
Posted: January 12, 2017
Reference ID: 295573287
A Clinical Trial Manager job in San Diego,CA needs to be filled immediately by Adecco Medical & Science. This is a direct-hire role. In this position you will complete tasks related to clinical studies in accordance with standard operating procedures, applicable guidance documents and government regulations.Adecco Medical & Science is a division of the world leader in medical and scientific professional recruiting.
Clinical Trial Manager job responsibilities:
Participate in Site Selection activities to support pre-approval and post-approval clinical studies.
Assists in selection and management of CROs when applicable
Work with Clinical Data Management and Biostatistics to ensure capture of study information to support endpoints.
Provide day-to-day direction and manage workload of project resources (CRAs)
Development of investigator brochures and study subject enrollment enhancement materials.
Assists in the development and authors investigational plans and clinical protocols and clinical reports.
Train clinical study site staff on the use of Obalon products in accordance with the instructions for use. Provide technical support to customers pertaining to the use of Obalon products.
Provide clinical study training to site staff pertaining to protocol requirements and good clinical practice.
Develop or oversee the development of essential documents to support study conduct
Assist with the development of departmental procedures and other documents pertaining to clinical studies and the use of Obalon products.
Coordinate investigational site training and supports investigator meetings.
Assist with the preparation of US and international regulatory submission for the conduct of clinical studies and the approval of new products.
Assists in the preparation of clinical deliverables for pre-IDE and IDE submissions and other interactions with the FDA.
Bachelor's degree (B.S. preferred.) from four-year College or University plus five years related experience and/or training; or equivalent combination of education and experience. Degree in Biology, Health Sciences or related field of study is highly desirable.
5+ years of demonstrated experience in clinical study management to support medical device regulatory approval applications.
Medical device experience highly desirable.
If you are interested in this Clinical Trial Manager job in San Diego,CA then please click APPLY NOW. For other opportunities available at Adecco Medical and Science go to www.adeccousa.com or email your resume to Melody.Lam@adeccona.com
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
- It seems like a big portion of the activities are related to study and site start-up, is that accurate? Yes.
- Do they need specific product or therapeutic area experience? Device.
- Top 3 most important tasks? Oversight of clinical study from start up to completion, management of site relationships, management of Sr. CRA and CTA.
- Would you hire someone such as a sr. CRA who has experience in these areas? OR Can be a Sr. CRA with management exp.
- Do you want someone who has previously been a CTM?
- Any specific documentation experience required? Yes.
- Experience with submissions required?? No.
- What is the company like, what is the team like? What type of person would fit in well here? Start-up environment, small clinical department (only 6 individuals), long hours, team oriented, fast-paced. At times there can be strife between clinical ops and R&D.
- More details on exactly how much travel there will be and where? Less than 25%. Within US.