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Associate Director, Clinical Operations
Summary
Title:Associate Director, Clinical Operations
ID:1025
Description

This new role will be responsible for the execution, and reporting of all clinical trial activities, ensuring adherence to study timelines, budgets, Quality Plans and applicable FDA/ICH/NIH guidelines. The individual in this position will also be responsible for effective management of Clinical Contract Research Organization activities.

Responsibilities:

  • Writes and/or reviews protocols, protocol amendments, informed consent forms, annual reports and regulatory submission documents.
  • Participates in interim reporting requirements to DSMBs and NIH.
  • Participates in the development of outsourcing strategies, including the selection of CRO’s and other external vendors, and the development of clinical trial budgets.
  • Manages/monitors clinical study activities and execution by the CRO’s.
  • Participates in the development of EDC and IWRS specifications for the clinical studies
  • Accountable for ensuring that all studies are carried out according to the study protocol, SOPs, applicable GCP/ICH guidelines.
  • Identifies and resolves problems, conflicts and obstacles to the success of projects.
  • Participates in clinical operations process improvement initiatives to address clinical needs (e.g., development of investigator database, standardized CRF modules, etc).

Requirements:

  • B.S/B.A. degree in a science-related field
  • 7+ years of clinical research experience, including clinical trial execution and reporting
  • Must have experience in Phases 1-3 with international trial experience
  • Familiarity with data management, as well as electronic data capture tools and 21CFR11 requirements
  • Excellent knowledge of ICH/GCP guidelines
  • Strong medical/scientific writing skills
  • Experience authoring protocols and clinical sections of clinical documents

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