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Director of Clinical Affairs

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Location
MN
Job Type
Direct Hire
Date
Oct 26, 2018
Job ID
2635849
Our mid-sized medical device client is looking for a Director of Clinical to provide oversight and managment of their clinical department.  This person will report to the VP R&D/Clinical. There will be around 5 direct reports including a Sr. Manager of Clinical. There are a number of new products in development and the clinical studies will be conducted in the US and OUS.

Your role with the company:
  • Direct and set strategy for managment of clinical studies including
    • Preparation of study materials and training of investigators and clinical staff
    • IRB submissions; determine and management of  site supplies
    • Screening of potential clinical investigators and sites, including evaluating facilities, personnel, and patient referral base.
    • Interactions with company functional teams, clinical investigators and sites.
    • Monitoring plans and coordination of clinical study monitoring activities if a CRO is not being utilized including, site selection, investigator meetings, site initiations, interim site monitoring visits and site closure visits.
    • Completion of monitoring reports
  • Supervises clinical studies consistent with R&D and Marketing plans which include assistance in writing study protocols, designing case report forms, and developing consent forms.
  • Develops/directs clinical study monitoring priorities if CRO used.
  • Reviews and assists with monitoring reports associated with each visit if CRO not utilized.
  • Ensures studies are completed on time, within budget and in compliance with SOP’s, FDA regulations and ICH/GCP guidelines.
  • Analyzes/reports safety issues, patient care issues, and study design issues.
  • Manages study database compliant with FDA CFR 21 Part 11 to ensure confidentiality, accuracy and producible audit trail.
  • Knowledgeable in EU regulations and able to facilitate international relationships pertaining to clinical trials performed in Europe.
  • Leverages key investigator relationships to participate in promotion of company (key speaker at conferences, etc.)
  • Oversees the overall activities of contracted CRAs and/or companies CRAs and Clinical and Reimbursement personnel
  • Negotiates and oversees the development of Clinical Evaluation and Consulting agreements for clinical projects and reimbursement activities.
  • Manages all aspects of departmental budget as well as individual study budgets.  Generates quarterly reports for Finance Department.
  • Provides interim and final reports and presentations to upper management on progress of studies and projects.
  • Works effectively as a member of the team, in providing direction and support to direct reports and in collaboration with peers on clinical and reimbursement projects and regularly interacts with senior management.
  • Establish and direct reimbursement strategies in collaboration with Marketing and Distribution.
  • Interfaces with representatives from key functional groups including Clinical Engineering, Product Development, Manufacturing, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups for clinical and reimbursement projects.
  • Serves as primary point of contact on the project for all internal and external communications for project related issues.
  • Identifies scope changes and works closely with senior management to resolve any issues that may jeopardize project success.
  • Contributes to the development and review of Clinical and Reimbursement SOPs
  • Requires approximately 20% travel

Desired Profile:
 
  • Registered Nurse or Bachelor’s Degree in related field, Certified as CCRP or CCRA
  • Experience as Director of Clinical at a medical device manufacturing company
  • Broad Knowledge /understanding of FDA regulations, GCP’s, clinical trial design and documentation, and the conduct of clinical trials. 
  • Familiar with European Directives.
  • Excellent verbal and writing communication skills to assure optimal interactions between RTI, contract vendors, and clinical sites
  • Strong  leadership, interpersonal and organizational skills
  • Success developing and managing budgets, schedules and performance requirements