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Director of Clinical Studies
Job Number: #2017-18
Location: St. Paul, MN

EnteroMedics is looking for a Director of Clinical Studies to oversee the management of multiple clinical development studies. The director participates in planning, development and preparation of annual budgets. This position manages 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.

ESSENTIAL FUNCTIONS

Assure overall successful conduct of all clinical studies consistent with applicable regulations, guidelines and polices which will fulfill the Company’s Research and Development, Marketing and Regulatory plans. This includes interfacing with representatives from key functional groups including Field Clinical Operations, Product Development, Marketing, Distribution, Finance and Regulatory Affairs.

  • Provides direction to manager of clinical operations.

  • Assists in the development of short and long-term objectives for the clinical team.

  • Oversees review and approval of study budgets, including site and CRO budgets; actively monitors study expenditures and payments. Approves or designates approval of study site and vendor payments, as appropriate.

  • Direct contributor in providing interim and final reports/presentations for regulatory submissions, safety monitoring groups and internal uses

  • Lead clinical team to meet company enrollment goals

  • Ensures that standard operating procedures for the conduct of clinical studies are followed and assesses compliance on a regular basis.

  • Presents study status and results to senior management of the company

  • Responsible for the design, planning, budgeting and management of clinical trials

  • Lead the development and contribute to clinical investigational plan

  • Responsible for preparation of study materials and research study training of investigators, center staff, monitors and companies field staff.

  • Prepare and lead Investigator/coordinator meetings.

  • Oversee DSMB function, ensure SAE’s are adjudicated and manage DSMB Charter

MINIMUM REQUIREMENTS

  • This position requires a Bachelor’s degree preferable in a technical field (defined as engineering, biological science or related medical/scientific field.

  • A minimum of 10 years experience directly supporting clinical research or similar experience in a medical or scientific area is required.

  • The individual must have a proficient knowledge of medical terminology and knowledge of clinical and outcomes research study design in addition to expertise with GCP (Good Clinical Practices) and regulatory compliance guidelines for clinical trials.

  • Position requires good problem solving skills, advanced written and oral communications skills and ability to manage and follow up with multiple tasks.

  • Must be detail oriented and possess a high aptitude for accuracy and the highest quality standards

  • Must be able to demonstrate the ability to work effectively on cross-functional teams.

 If you are interested in applying for this position, please fill out this form to submit your resume.