FREELANCE - Clinical Trial Manager - 12 months
- Experience Level
Position: Clinical Trials Manager
Contract: 12 Months
Location: West London (Remote Working)
Umbilical Life is working with a Pharmaceutical client to source an experienced Clinical Trial Manager who has strong experience working on late phase, non-interventional studies.
The CTM will be responsible for managing post-authorisation studies and Investigator Sponsored Research across different therapeutic areas.
Working closely with Global Trial Managers, you will provide an ‘A to Z’ oversight of Investigator Sponsored Trials including, but not exclusive to, Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.
You will work closely with other Clinical Program Managers, identifying challenges within the regional area of global post-authorisation studies.
Equally managing the end-to-end process of EU post-authorisation studies…
You will be experienced in managing relationships within cross functional teams, on both an internal and external basis.
As standard, you will be the primary point of contact for CROs, responding to questions and utilising your knowledge to reach a resolution to any problems faced.
Qualifications & Experience:
- Educated to degree level in a relevant scientific discipline or equivalent
- ESSENTIAL: Experience in the management of Late Phase [IV] and Non-Interventional studies essential.
- DESIRABLE 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.
- Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
- Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
Reference ID: 17422