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Clinical Project Manager

PostId 3fa1e0a9-4d96-431d-acc5-782ec142b788
Posted Date: 6/22/2010
Job Category: Clinical - Pre Clinical
Salary Range: DOE
Location: Bay Area (Peninsula)
Description: Position Title: Clinical Project Manager
Reports To: VP of Clinical
Location: Peninsula
Company: Public

Summary:

The Clinical Project Manager (CPM) will execute clinical trials of investigational medical devices. The CPM will ensure that clinical trials are executed in accordance with applicable regulations and that the quality of clinical data generated from clinical trials meets the FDA requirements for PMA approval. The CPM may also execute post marketing studies of approved medical devices either to comply with FDA PMA approval conditions or to generate additional clinical information for marketing purposes.

Essential Duties and Responsibilities:

1. Perform evaluations of potential investigational sites and investigators for participation in clinical trials.

2. Perform audits of investigational sites and investigators to ensure data integrity and protocol compliance.

3. Assist with negotiating and obtaining approval for investigator agreements.

4. Prepare IRB submission applications and obtain IRB approvals.

5. Educate, train and support investigators and their staff prior to and during clinical trials of investigational devices.

6. Manage contract monitors.

7. Assist with development of clinical protocols, case report forms, informed consent forms, investigator manuals, product instructions for use, and study training materials.

8. Assist with preparing clinical data summaries for FDA submission.

9. Interface with data management to resolve data queries and to ensure data integrity and completeness.


Working Relationships:

Internal - Position interacts on a regular basis with all members of the Clinical Affairs Team and with members of other departments as a representative to internal project teams as appropriate.

External – Position interacts with investigational site personnel including investigators, their staff, clinical and administrative personnel; contract monitors, and data management.

Decision-Making Authority:

This individual will make decisions together with the Vice-President of Clinical Affairs and will at times be required to make critical independent decisions when working with investigational sites and IRBs.

Position Requirements and Competency Measurements:

Education and/or Experience (years): Bachelors degree from an accredited college required. Minimum of 7 years experience in clinical research of medical devices. Proven knowledge of and extensive experience with IDE and PMA submission requirements and applicable FDA regulations.

Knowledge, Skills and Abilities: Excellent organizational skills and pay extreme attention to detail. Excellent interpersonal and oral/written communication skills and be able to work independently.

Physical Demands: Must be able to travel overnight by airplane approximately 50% of the time. Able to stand and speak in front of a group. The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment: The work environment characteristics described are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.