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Director, Clinical Operations, Infectious Diseases
Ref No.: 18-07410
Location: Cambridge, Massachusetts
Position Type:Contract
Start Date: 06/19/2018
Position Summary
Client innovative mRNA platform will allow its Infectious Diseases therapeutic area to start the clinical development of multiple vaccines over the coming months. Infectious Diseases is therefore recruiting a Clinical Operations Manager to manage these studies. This position will be responsible for initiating and leading phase 1 and 2 clinical trials development, set-up, implementation and completion. This will be accomplished by working with the internal project team and through a preferred provider CRO and other external contractors. This role will report internally to the Head of Clinical Operations and work closely with the Regulatory team of the Chief Medical Officer of client
  • Leadership of first-in-human and phase 2 vaccine clinical trials ensuring GCP and FDA Regulatory compliance.
  • Work with the internal project team and manage the preferred provider CRO team and vendors to plan and implement clinical trials for several new vaccines.
  • Develop and lead the review of clinical outsourcing strategies and plans.
  • Manage assigned vaccine clinical trial budgets and resource assignment.
  • Responsible for representing Clinical Operations on cross-functional project teams and Vendor/CRO operational meetings and ensuring compliance with global operational standards and procedures.
  • Initiate and lead monitoring oversight activities are conducted in accordance to client and ICH/GCP standards.
  • Represent the Company externally to Investigators and trial site administrators.
  • Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct.
  • Maintain oversight and participate in the review of departmental SOPs to ensure compliance.
  • Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader client organization.
  • PhD and 10 years' experience, MS with 10-15 years' experience or BA with 15-20 years' experience.
  • At least 8-10 years of management experience in an infectious disease vaccines clinical research environment
  • Multi-dimensional Clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
  • Cross Collaboration proficiency with other functions such as R&D, Finance and production
  • Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world
  • Experience in regulatory GCP inspections/audits
  • Outstanding verbal and written communication skills, in addition to excellent organizational skills
Creative, capable problem-solver