Are you an experienced Clinical Trial Manager looking for a new and exciting opportunity to gain further experience?
We are currently looking for a Clinical Trial Manager to join a growing biotechnology company based in the London area, who\'s advanced therapy treatment are entering Phase III trials.
Your main objectives in the role of Clinical Trial Manager will include: Clinical trial management of studies using industry standard project management tools and training materials and compliance with Good Clinical Practice, standard processes and procedures.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Trial Manager will be varied however the key duties and responsibilities are as follows:
1. Primary accountability for operational study level time, cost and quality deliverables. Independently oversees all operational clinical research activities for a study or series of small studies. Oversees execution of studies according to ICH/GCP guidelines.
2. Negotiate budgets and trial agreements with sites. Approve invoices within scope of agreed budget for assigned studies
3. Accountable for site management and communication with sites. Accountable for site initiation activities including feasibility and the regulatory site activation process. Recommends sites to include or exclude from study.
4. Regularly review site and team communications, Monitoring Visit Reports and quality assurance audit findings to assess quality issues within the project. Implement corrective action plans and ensure appropriate escalation through the team.
5. Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible studies. Responsible for outsourced vendor management oversight and invoicing for responsible studies. Monitors and assesses vendor performance against contractual operational deliverables. Accountable for TMF review and maintenance of clinical operations inspection readiness.
To be successful in your application to this exciting opportunity as the Clinical Trial Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biological Sciences focussed discipline.
2. In addition to this, you will be expected to have gained some experience working as a Clinical Trial Manager within a commercial setting, or working as a Senior Clinical Research Associate (again within a commercial setting.
Key Words: Clinical Trial Manager | Clinical Research | Clinical Trial
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Eve Hegarty
- Phone: 0131 202 9700
- Reference: J5634309
Website: Hyper Recruitment Solutions
- Posted: 14th January 2021
- Expires: 11th February 2021