Clinical Programs Manager - Medical Device Industry
Location: Minneapolis Minnesota
Description: Hudson Global Resources is at present recruited Clinical Programs Manager - Medical Device Industry right now, this job will be placed in Minnesota. More complete informations about this job opportunity kindly read the description below. We've been engaged by our client to recruit for their Clinical Programs Manager position. The Clinical Programs Manager will manage the successful completion of all clinical programs.
Responsibilities:
- Manage the successful and timely execution of all device clinical trials
- Responsible for the selection, training and management of all Clinical Research Associates including their training and compliance with all SOPs and associated regulations
- Responsible for the training, initiation and management of clinical trial sites
- Establish and manage trial budgets including enrollment targets
- Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending
- Participate in the design and development of new trials
- Responsible for the timely development of clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis
- Develop and maintain individual training programs for all staff
- Able to assist in the drafting and development of publications based on the results of the clinical trials
- Develop and maintain strong relationships with principal investigators at clinical trial sites
- Travel estimated at 15%
- BA/BS in life sciences or nursing
- 10+ years of experience in clinical research
- 5+ years of experience successfully managing a team of clinical research professionals
- 5+ years clinical research experience in medical device
- Demonstrated knowledge of and experience with GCP and all US regulations
- Hands on experience in IDE clinical trials and the preparation of PMAs
- Comfortable in both the clinical and business setting
- Comfortable presenting to senior management
- Ability to work independently and take direction from others
- Experience in the cardiovascular therapeutic areas preferred but not necessary
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Hudson Global Resources.
If you interested on this job just click on the Apply button, you will be redirected to the official website
This job starts available on: Thu, 05 Jul 2012 22:56:20 GMT
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