Medical Device Product Manager

Company Name: S & B Consulting Group
Location: Addison, TX United States
Job Category: Healthcare
Job Type: Full Time- Direct Hire
Salary: 100000 United States dollar (USD)

Jennifer Simpson-Black
View Profile

Required Skills & Job Description

Must Have Skills: Must have Spinal, Foot, or Ankle experience. Minimum of a bachelor's degree in a scientific discipline and five years clinical trial experience. Advanced knowledge of good Clinical Practice and Regulatory compliance guidelines for clinical trials in the United States.
Education: Bachelor's Degree

Description:

This is not a Project manager position.. Please only apply if you have Medical Device Experience!

Job Description
Summary Overview: Administer project management of multiple clinical trials in accordance with appropriate medical device regulations and Good Clinical Practices (GCP) to obtain clinical data to support new and existing products.

In the management of clinical studies, the following will occur:
* Determine clinical study objectives, strategy, scope, and budget and schedule in order to meet needs.
* Research, prepare and revise Investigational Plan in collaboration with key clinicians, regulatory agencies and internal personnel.
* Recruit qualified clinical investigators, obtain and manage investigator and compensation agreements.
* Prepare and manage study documentation, such as case report forms, informed consent forms, study logs, etc.
* Obtain approvals for trial implementation from regulatory agencies. * Train clinical investigators and support staff.
* Conduct site visits, site audits and related clinical monitoring functions, ensuring the completeness and accuracy of collected data and the site's adherence to protocol.
* Collect, analyze and summarize clinical data for submission to regulatory agencies for product approvals and for marketing support purposes.

Responsibilities:
1. Project Management: Execute clinical studies in compliance with applicable regulations, GCPs, SOPs and study timelines. Activities include in-house and on-site monitoring trials as necessary, overseeing data management/query resolution and assisting in summarizing clinical data for submission to regulatory agencies for product approvals and marketing.
2.Protocol Development: Develop protocols in conjunction with Director, Clinical Affairs, to gather data to support regulatory and marketing needs.
3.Writing Clinical Reports 4.Management and Administrative Duties (e.g., supervision of support personnel, budgets, documentation preparation).
Job Requirements

Minimum of a bachelor's degree in a scientific discipline and five years clinical trial experience. Advanced knowledge of good Clinical Practice and Regulatory compliance guidelines for clinical trials in the United States, Europe Union and other major regulated countries. Strong project management skills. Working knowledge of adverse event management and reporting. Advanced written and oral communication skills, with medical terminology. Willingness to travel as much as 30%, domestically and internationally. Computer skills that include work processing, spreadsheet, database management and Internet. Ability to develop relationships with and interact effectively with physicians, study coordinators, Client sales personnel and other individuals. Ability to multi-task and direct several studies at the same time. Ability to work and collaborate effectively with co-workers in various Client departments. Strong team participation and team management skills.

Must have Spinal, Foot, or Ankle experience.

Apply for this Job

Contact Information Company Name: S & B Consulting Group Contact Name: Jennifer Simpson-Black Contact Number: 972 536 3585 Company Website: http://www.sbconsultinggroup.net Additional Benefits: Company Description: Date Posted: 2010-03-08 14:32:20