Clinical Trial Manager - new job in

Clinical Trial Manager
  • Competitive
    ANNUM
  • Permanent
  • England, UK UK OX1 1AE
Job Ref: J2166452
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 14 September 2022
SRG are currently looking for a Clinical Trial Manager on a permanent basis for a growing Biotech organisation. This role will be 100% remote with...

SRG are currently looking for a Clinical Trial Manager on a permanent basis for a growing Biotech organisation. This role will be 100% remote with the expectation to attend the serviced office based in Oxford once a month.

The Role:

Reporting to the Associate Director of Clinical Operations, who is the Global Study Lead, this role will hold full responsibility for over site of the organizations appointed CRO. This will involve managing the clinical trial sites for one global neonatology study

Role responsibilities will include but will not be limited to

Developing trial level time lines and ensure all trial deliverables are met according to time lines, budget, operational procedures and quality/GCP standards

Main point of contact for CRO, third party vendors and study sites to ensure sponsor's oversight responsibilities

Hands on management of CRO performance

Ensure optimal operational conduct of clinical studies (participation in feasibility assessments, site selection, site visits/co-monitoring, management of Investigator/study site interactions, recruitment management and risk mitigation.)

Development of clinical study protocols and related documents

Regularly update all trial information databases and tracking systems

Provide study status updates to relevant internal meetings

Ensure maintenance of Trial Master File in strict compliance with ICH/GCP and internal SOPs, and ensure clinical documents are filed in appropriate designations and ensure an up-to-date audit trial

Ensures inspection / audit readiness including Trial Master File documentation at all times, working with the CTA to ensure documents are filed correctly and in a timely manner.

Skills/Experience Required:

* Minimum of 5 years of experience in clinical trial execution in a biotech company

* Proven track record of managing a clinical trial from setup to clinical study report (including setup of eCRF, IRT, laboratory related tasks, etc.) company

* Experience of running Early phase (Phase I/II) clinical studies

* Comprehensive understanding of the international aspects of drug development process, including knowledge of international standards (GCP/ICH), health authorities (FDA, EMA), local/National Health Authority regulations

* CRO and site management capabilities with demonstrated ability to solve problems and mediate potential compliance issues

* Experience and natural ability of leading cross-functional teams

* Autonomous, self-starter who can make decisions independently

* Good oral and written communication skills

If you are interested in this role or would like to have a confidential career discussion regarding other Clinical opportunities. Please contact me: angela.barclay@srgtalent.com or +447384 836 266

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
14/10/2022 19:05:57
GBP Annum
Contact Consultant:
Angela Barclay

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