Interim Director Clinical Operations

Posted 29 February 2024
Salary Competitive Hourly Rate
Job type Contract
Contact NameDaniel Jeffery

Job description

Consultant: Interim Director of Clinical Operations (2-4 month assignment)
Location: Copenhagen, Denmark
  • Performing vendor selection and oversight, including RFP and qualification process, vendor meetings, PD & monitoring report review; managing vendors to ensure the successful execution of clinical trials
  • Developing and overseeing project plans to ensure adherence to the agreed timelines, quality and budget
  • Developing Sponsor plans (oversight, risk management, etc.)
  • Maintaining Sponsor trial documentation
  • Developing and managing trial budgets within budget constraints
  • Supporting the development of study-related documentation, including study protocols, Informed Consent Forms (ICFs), Investigational Brochures, and Clinical Study Reports.
  • Supporting timely and efficient database lock by overseeing monitoring plans and participating in data review and reconciliation efforts.
  • Coordinating and presenting key study metrics, including subject enrolment, site selection/feasibility, and data collection.
  • Hands-on experience leading early-stage (first-in-human to Phase 2) clinical trials.
  • Comfortable working in a fast-paced environment with minimal formal infrastructure.
  • Familiarity with US and EU regulatory and data quality standards, including Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with internal and external stakeholders.