Director of Clinical Studies (Job ID: 172 CDS)
Ann Arbor, MI

Position Summary:

The client company is a worldwide leader in medical products, manufacturing, distributing, and marketing high quality capital equipment and consumable medical devices. The company is seeking a Director of Clinical Study will be responsible for the preparation, implementation, and monitoring of all facets related to US clinical trials for implantable device. You will work with medical scientific experts, marketing, research project teams and to develop government regulatory compliance functionality. You will also develop external research programs by aligning specific projects with experts to maintain communication on emerging scientific knowledge. The Director will participate and/or assist in planning, strategic development and preparation of annual budgets and will manage all components of the clinical trial that will provide the company with the necessary clinical trial data and device functionality for successful and timely FDA approvals to insure that the clinical trials provide the development team with critical device performance information.

Primary Responsibilities:

• Effective management of all clinical trial related components directed toward the timely and successful market release of the entire product line
• Establish and monitor all clinical trial standard operating procedures (SOP) relative to regulatory and corporate guidelines
• Clinical Study protocol development and implementation
• Evaluation and qualification of appropriate investigative centers to optimize implant rates and data collection
• Device implantation, troubleshooting and follow-up as directed by the protocol
• Clinical site education and maintenance relative to device functionality and clinical and regulatory adherence
• Recruitment, management, and development of all field related personnel
• Effective management of the Clinical Research Organization (CRO) and database
• Support the education and training of all customers impacting the clinical trials process

Education Requirements:

• Bachelor’s degree in health science, education, nursing bioengineering or business is required

Position Requirements:

• Six to ten years of experience in the design and management of clinical trials within the cardiovascular implantable device industry.
• Three to five years of experience in the management of direct reports
• Excellent interpersonal and written and oral communication skills
• Working knowledge of the therapy’s customer profile, including business and clinical practices
• Strong management skills including strong influence management and conflict resolution skills
• Extensive project management (objective, time, budget) experience
• Strong knowledge of MS Word, Excel, Powerpoint and Outlook

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