This position is located in Michigan.

Exciting opportunity with a Global World Class Medical Device Company

Desirable Michigan location!

Relocation, bonus, great benefits with matching 401k plan!

Responsible for preparation, implementation and monitoring of all facets related to U.S. and Canadian clinical trials. Management of all components of the clinical trial to provide the company with the necessary clinical trial data and device functionality for successful and timely regulatory approvals.

  1. Maintain and follow proper compliance and quality systems requirements.
  2. Effectively manage all clinical trial related components directed toward the timely and successful market release of assigned product(s).
  3. Specific clinical trial management incorporates the following:
    • Protocol and CRF development / implementation.
    • Evaluation and qualification of appropriate investigative centers to optimize implant rates and data collection.
    • Clinical site education and maintenance relative to device functionality and clinical / regulatory adherence.
    • Recruitment, management and development of Clinical Studies Specialists.
    • Effective management of contracted Clinical Research Organization (CRO), database, outside consultants and trial sites.
    • Support the education and training of all customers impacting the clinical trials process.
    • Monitor of all clinical trials standard operating procedures (SOPs) relative to the regulatory and corporate guidelines.
    • Assists the VP, Regulatory and Clinical Affairs, to determine the study objectives, scope and schedule in order to meet corporate objectives.
    • Interfaces with regulatory agencies including Pre-IDE meetings with the FDA and presentations to the FDA regarding requirements and results of the clinical study.
    • Interface with representatives of functional groups including Clinical Studies Specialists, R&D, Manufacturing, Marketing, Regulatory Affairs and the European Clinical Group.
    • Selects, interfaces with and ensures training of investigators, site staff and the company’s clinical staff.
Requires a four-year degree in biological sciences or related medical / scientific field, health education, nursing or business. Requires at least 5 years’ experience in the design and management of clinical trials within the cardiovascular implantable device industry plus at least three years’ experience in the management of direct reports. Excellent interpersonal and written / oral communication skills. Working knowledge of the device customer profile, including business and clinical practices. Strong management skills including strong influence management and conflict resolution skills. Strong project management (objective, time, budget). Computer skills (MS Word, Excel, PowerPoint, Outlook).

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Clinical Studies Director - Michigan

For more information, or to submit your resume, contact Gail Hutnik.