Umbilical Life 13557: UK, West London – Excellent Rate / hour – 12 month rolling contract
James Carrera at Umbilical is recruiting for an experienced Clinical Trial Manager for a major client who is experienced in the management of Post Authorisation Studies, in particular Non-Interventional Studies, across different therapeutic areas; providing support & oversight of Investigator Sponsored Trials.
Works with Clinical Program Managers to manage the European component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes. Interacts with cross-functional teams internally and externally to ensure study progress. Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems
Educated to degree level, you must have 2-3 years minimum multinational clinical trials experience including study management / coordination as well as;
Previous experience in the management of Phase IV and Non-Interventional studies essential. Experience in the review and oversight of Investigator Sponsored Trials desirable. Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies. Must be able to generally understand, interpret, and explain protocol requirements to others. Good knowledge and understanding of ICH GCP, GVP, FDA and EMEA regulations and guidelines applicable to post-authorization studies. Must be able to prioritize multiple tasks or interdepartmental strategic initiatives under limited supervision
For a confidential discussion please contact
James Carrera on (0)
Job Title:FREELANCE: Clinical Trial Manager – Late Phase – Non-Interventional St