Clinical Study Operations Lead

4 dagen geleden


Groningen, Groningen, Nederland PRA Voltijd

About ICON

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

We have a mission to succeed and a passion that ensures what we do, we do well.

The Role

We are seeking a Clinical Study Operations Lead to provide clinical trial management for in-house and outsourced studies, perform quality checks, protocol and document development, and execute study delivery plans aligned with program goals and timelines.

Responsibilities

  • Reviews and assesses the research protocol, clinic budget, case report forms, informed consent forms and study volunteer information.
  • Participates in the assessment, preparation and implementation of studies for the clinic to ensure a timely and high-quality study output.
  • Conducts feasibility analysis. Reviews availability and workload for study volunteers, practicability and required personnel. Creates risk analysis and contingency plans. Coordinates in- and outpatient visits.
  • Serves as liaison between all clinic groups and the applicable clinic management. Communicates any changes in scope and/or cost and escalates issues and/or major deviations. Serves as clinic contact for the study sponsor.

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