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Consultant: Interim Director of Clinical Operations (2-4 month assignment)
Location: Copenhagen, Denmark
Responsibilities:

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.

Qualifications:

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.

Interim Director Clinical Operations