Head of Experimental Medicine – London

Jim Gleeson at CK Clinical is recruiting for a permanent Head of Experimental Medicine to manage expanding Phase I operations at a world renowned London hospital.

Responsibilities:

As a Head of Experimental Medicine you will develop and grow a clinical research facility delivering highest quality First in Man studies and attract strategic partnerships with leading pharmaceutical, diagnostic and other companies within the healthcare arena. You will also have the following responsibilities:

  • Managing the set up of early phase trials, supporting the development of in house capabilities and the management of external partnerships
  • Ensuring that trials run on time and on budget as well as in compliance with all protocol and governance requirements
  • Line and budgetary management
  • Oversight of the Quality Management System
  • Ensuring the delivery of trial performance metrics, operational analysis reporting, patient recruitment and study scheduling for facility and satellite sites
  • Maintaining preparedness for internal and external audit and leading sites through such audits
  • Assessment of personnel, financial and material requirements for studies and co-ordination of necessary procurement
  • Act as an ambassador for the facility to ensure development of high quality trials and attraction of commercial studies to the organisation

Qualifications and skills:

The successful candidate for this Head of Experimental Medicine role will have the following qualifications and skills:

  • A relevant BSc, MSc or nursing qualification
  • Extensive experience of managing early phase clinical trials
  • Thorough knowledge of the regulatory frameworks governing early phase experimental trials
  • Experience of hosting audit and regulatory inspections
  • Line management experience
  • Quality Management Systems experienceJim Gleeson - Senior Consultant at CK Clinical

How to apply:

Apply online:

For more information or to apply for this Head of Experimental Medicine position please contact Jim Gleeson at jgleeson@ckclinical.co.uk or on 01438 842973. Please quote reference CL24677 in all correspondence.

 

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Senior Quality Assurance Auditor – London

Jim Gleeson at CK Clinical is recruiting for a Senior Quality Assurance Auditor to join a leading healthcare charity at their site in London

Responsibilities:

As a Senior Quality Assurance Auditor you will be supporting a busy drug development team within a leading healthcare charity where you will plan, execute and report on Phase I and II clinical trials. These audits will be both internal and external and include Investigator Sites, laboratories, documentation, TMFs and databases. Activities will include assisting in staff training, representing the organisation at conferences and the review and update of SOPS.

Qualifications:

To be considered for this Senior Quality Assurance Auditor role you must have the following qualifications and skills:

  • BSc or Nursing qualification
  • QA auditing experience gained within clinical trials
  • An excellent understanding of ICH GCP
  • A good knowledge of the EU clinical trials regulatory documents that affect UK clinical trials
  • Excellent interpersonal skills and able to work in a highly collaborative fashionJim Gleeson -  Senior Recruiter at CK Clinical

How to apply:

Apply online:

For more information please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL24650 in all correspondence

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Senior Clinical Quality Assurance International Auditor Job in Switzerland

Jim Gleeson at CK Clinical is currently recruiting for a Senior Clinical Quality Assurance International Auditor to join one of the world’s leading pharmaceutical companies at their prestigious head quarters in Switzerland.

A number of positions are available with this pharma company covering both clinical operations and manufacturing compliance.

Senior CQA International Auditor Job Description:

As Senior CQA International Auditor, you will lead GxP audits on a global basis to ensure that all activities, whether performed in-house or via third party organisations, are fully compliant with all company, national and international regulations and legislation.

Further responsibilities will include:

  • Planning, coordinating and executing both routine and directed audits globally
  • Analysis of audit results and recommendation of corrective actions
  • Coordination and conduct of pre-inspection activities
  • Development and implementation of GxP training
  • Act as an expert GxP consultant for other functional areas

Qualifications, Skills and Experience:

  • As Senior CQA International Auditor, you will have the following qualifications, skills and experience:
  • Very extensive auditing experience within either a GCP or GMP environment
  • Excellent oral and written English communication skills
  • A second language, such as German, French, Italian or Chinese, would be advantageous
  • Auditor certification from an industry recognized body
  • Willingness to travel globally, up to 60%

 

How to apply:

 

 

 

Jim Gleeson - Clinical Quality Assurance Recruitment at CK Clinical

Please contact Jim for more details.

Please click here to apply online now.

For more information regarding this Senior CQA International Auditor, please contact Jim Gleeson at CK Clinical on +44 (0)1438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL24266 in all correspondence.

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Clinical Compliance Manager Job in London

Jim Gleeson at CK Clinical is currently recruiting for a Clinical Compliance Manager to join a global pharmaceutical company based in London.

As Clinical Compliance Manager you will:

  • Drive process improvement within clinical operations and lead the development of GCP quality management documentation.
  • Work in an international role and will be working cross-functionally and with many sites.
  • Deliver staff training on clinical trial procedures, SOPs and ICH-GCP
  • Contribute to quality document integration across the organisation.

As Clinical Compliance Manager you will have:

  • Proven experience with GCP quality management systems
  • Strong project management experience
  • Excellent written and verbal communication skills

How to apply:

Click here to apply online now.

For more information regarding this Clinical Compliance Manager job, please contact Jim Gleeson on  01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23989 in all correspondence.

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Clinical Manager Job in Home Counties

Jim Gleeson at CK Clinical is currently recruiting for a Clinical Manager to join an international pharmaceutical company at their site based in the Home Counties.

As Clinical Manager, you will have responsibility for all aspects of study management for assigned global studies from the concept and planning stage through to close-out. This will include resource allocation, documentation development, vendor selection and management, supplies management and CSR review.

To be considered for this Clinical Manager position, you will have the following skills and experience:
– Clinical project management experience on an EU or global basis, from start-up to close-out
– Urology trial experience would be advantageous
– The ideal candidate will also have had experience of trial monitoring
– Thorough understanding of ICH-GCP requirements
– Ability to travel up to 25%

How to apply:

Click here to apply online now.

For more information regarding this Clinical Manager position, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL23976 in all correspondence.

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Senior Clinical Compliance Specialist Job in London

Jim Gleeson at CK Clinical is recruiting for a Senior Clinical Compliance Specialist to join an international pharmaceutical company at their site based in London. This is a one year contract position.

As Senior Clinical Compliance Specialist you will ensure that European clinical trial activities are fully compliant with all internal and external regulations. This will cover the company’s own work and that of external vendors, managing technically complex audits and defining and communicating compliance risks.

 

As Senior Clinical Compliance Specialist you will have the following qualifications skills and experience:

  • Very extensive Clinical Quality Assurance experience, including hosting regulatory authority inspections
  • In depth knowledge of GxP regulation, ICH guidelines and FDA GCP requirements
  • Excellent understanding of the clinical trial and auditing processes
  • Ability to travel internationally, up to 40%

How to apply:

Click here to apply online now.

To find out more, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23127 in all correspondence.

 

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Meet Jim Gleeson – Clinical Operations, Clinical QA and Health Economics Recruitment

[youtube]http://www.youtube.com/watch?v=Ol_xZe-4e1o[/youtube]

 

Jim is a Senior Consultant here at CK Clinical and has over 15 years experience of recruiting for the pharmaceutical industry. He recruits on a global scale for the following three areas:

  1. Clinical Operations: Clinical Research Associates, Project Managers, Directors, Contract Outsourcing, Clinical Supplies
  2. Clinical QA
  3. Health Economics

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Meet the rest of the CK team here.

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Market Access Solutions Manager Job – Hertfordshire

Jim Gleeson at CK Clinical is currently recruiting for a Market Access Solutions Manager to join a leading pharmaceutical company based in Hertfordshire. This is a permanent position with a salary of around £40,000.

The role:

As Market Access Solutions Manager you will produce resources for use by the sales force when interacting with buyers. Examples of these resources will include Budget Impact Models, Cost Analyses and DoH Policy Iterations. Training will be available.

The ideal candidate:

To be considered for this position you will need to be highly numerate, IT literate, have good writing skills and have a dynamic personality. An ideal role for a creative and independent thinker with experience of pharmaceutical sales.

How to apply:

For more information or to apply for this Market Access Solutions Manager position, please contact Jim Gleeson at CK Clinical on 01438 870027 or email your CV to jgleeson@ckclinical.co.uk. Please quote reference CL23234 in all correspondence.

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Director of Clinical & Pharmacovigilance Job London

Jim Gleeson at CK Clinical is currently recruiting for an Associate Director of Clinical and Pharmacovigilance QA to join a global pharmaceutical company at their EU Headquarters based in London.

The role:

As Associate Director of Clinical and Pharmacovigilance QA, you will provide overall leadership for all EU QA activities within Clinical Development and Pharmacovigilance. In liaison with the global QA team your remit will be to ensure that these activities are fully compliant with ICH-GCP regulations and company policies and procedures.

Further responsibilities will include:

  • Act as the key QA representative for competent authority inspections for clinical trials and pharmacovigilance
  • Ensure that investigator, vendor, facility and system audits are carried out, that critical compliance risks are communicated to senior management and the corrective actions are implemented
  • Provide EU regional input to global quality initiatives
  • Identify and mitigate quality and compliance risks
  • Manage the EU aspects of the clinical audit and corrective action tracking database

 

 

The ideal candidate:

To be considered for this Associate Director of Clinical and Pharmacovigilance QA Job in London you will have the following skills, qualifications and experience:

  • Extensive and broad QA experience gained as either a client or vendor
  • Experience of study design, set up and conduct as well as of audits of all types
  • In depth knowledge of GxP regulations, EU regulations, FDA Good Clinical Practice and ICH guidelines
  • An understanding of Computer System Validation
  • Proven line management skills

 

How to apply:

For more information, or to apply for this Associate Director of Clinical and Pharmacovigilance QA please contact Jim Gleeson at CK Clinical on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23220 in all correspondence.

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Clinical Pharmacology Scientist Job – Hertfordshire

Jim Gleeson at CK Clinical is currently recruiting for a Clinical Pharmacology Scientist to join a global pharmaceutical company based in Hertfordshire.

The role:

This is a 1 year contract position and responsibilities will include:

  • The design, conduct and monitoring of a range of Clinical Pharmacology studies.
  • The range of studies includes but is not limited to first administrations, dose escalation, special populations, TMT, drug interaction and proof of concept.
  • Responsibility for co-ordinating the scientific and technical contributions of all relevant disciplines into the study, including data managers, statisticians, pharmacokineticists, bioanalysts, physicians, Clinical Pharmacology Unit staff and clinical supplies.
  • Participating in relevant team discussions (Clinical Matrix Team, Project Team) which impact study design, conduct, analysis and reporting.
  • Primary responsibility for one or more development compounds and/or one or more therapeutic indications.

How to apply:

For more information or to apply for this Clinical Pharmacology Scientist position, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL22996 in all correspondence.

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