Clinical Project Manager

Employer
Hobson Prior
Location
Hertfordshire, England, Stevenage
Salary
£45000 - £65000 per annum
Closing date
9 Oct 2020

View more

Discipline
Project Management
Hours
Full Time
Contract Type
Permanent
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Hobson Prior are looking for a Clinical Project Manager to join a top biotechnology organisation on a permanent basis in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.

Job Responsibilities:

  • Lead the planning and execution of clinical studies from Phase I to IV in adherence to Good Clinical Practice, Standard Operating Procedures, Food and Drug Administration regulations, EU Directives & Guidance, and International Conference on Harmonisation guidelines.
  • You will ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed by the Project Team.
  • Lead site selection and site qualification discussions with project team and CRO.
  • Ensure CRO selection is appropriate for the study planned.
  • Validate the study plans provided by the CRO through to study close out.
  • Accountable for management of CRO performance to ensure adherence to scope of work within timelines and budget at an overall study level.
  • Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study.
  • Recognise issues early and propose solutions
  • Create the budget at study planning and monitor the overall agreed budget against trial progress.
  • Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan.
  • Contributes towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
  • Co-operates with other key functions to maintain audit and inspection readiness.
  • Engage and build relationships with clinical sites in North America (and potentially South America)
  • Oversee CRO performance in US site set up, recruitment and patient follow up.

Key Skills:

  • Ability to communicate effectively, including with therapy area experts and patient advocacy groups.

Requirements:

  • Degree in a relevant discipline.
  • A minimum of 5+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at national and international level.
  • Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development including.
  • Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines
  • Strong scientific, operational and regulatory expertise.
  • Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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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