Clinical Trial Manager

Employer
Hobson Prior
Location
London, England
Salary
£40000 - £45000 per annum
Closing date
25 Sep 2020

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
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Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking a Clinical Trial Manager to contribute to the execution of gene therapy studies per development plan, from initiation through to closeout.

Job Responsibilities:

  • You will prepare and submit HRA application package for clinical trial approvals in the UK, and support approval application process in the US.
  • Negotiate budgets and trial agreements with sites.
  • Approve invoices within scope of agreed budget for assigned studies.
  • Accountable for site management and communication with sites
  • Accountable for site initiation activities including feasibility and the regulatory site activation process
  • Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible studies.
  • Accountable for outsourced vendor management oversight and invoicing for responsible studies.
  • Accountable for TMF review and maintenance of clinical operations inspection readiness for studies.
  • Collaborate internally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
  • 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.
  • Conduct co-monitoring visits.

Requirements:

  • Ensure regulatory compliance in terms of MHRA, FDA and EU framework.
  • Understand and adhere to the principles of ICH GCP and regulatory requirements in both the EU and US.
  • Educated to Degree level (or equivalent) in a Biological Science discipline.
  • A minimum of 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
  • A minimum of 2+ years of clinical trial management experience in a commercial setting.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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