Senior QA Auditor - Medical Devices - Germany or Switzerland

This expanding, global CRO is looking to recruit a Senior QA Auditor - Medical Devices to be based in either Germany or Switzerland In this role you will conduct all aspects of internal and external auditing, to include sponsor and investigator audits, to ICH GCP and ISO14155 for the company's medical device studies.

Audits will be system, process, facility, documentation and site focused, across Europe. In addition to your auditing duties you will have the chance to get involved in supervising a junior QA Auditor, with a view to taking on line management responsibilities and a QA Manager role in the near future.

Who are we looking for? A scientific background is essential along with a proven track record of medical device auditing to ICH GCP requirements. Full training will be provided to candidates with strong ICH GCP auditing experience. Practical experience with all types of internal and external audit is essential. A competitive salary and remuneration package is available to the successful candidate. If you are looking to broaden your auditing experience within clinical trials then please call Kristina on 01279 657716 or email Kristina@seltekconsultants.co.uk

Please note that your details will kept entirely confidential, and we will contact you prior to sending your CV to any company.

Job Ref: 8118

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Senior QA Auditor - Spain, Italy or France - to €50K

This expanding, global CRO is looking to recruit a Senior QA Auditor to be based in either Spain, Italy or France. In this role you will conduct all aspects of internal and external auditing, to include sponsor and investigator audits, to ICH GCP and ISO14155.

Audits will be system, process, facility, documentation and site focused, across Europe. In addition to your auditing duties you will have the chance to get involved in supervising a junior QA Auditor, with a view to taking on line management responsibilities and a QA Manager role in the near future.

This is an excellent opportunity to gain QA expertise within another area of clinical product development, whilst at the same time gaining valuable leadership and management skills for the future!

Who are we looking for? A scientific background is essential along with a proven track record of auditing to ICH GCP requirements. Full training will be provided to candidates with strong ICH GCP auditing experience. Practical experience with all types of internal and external audit is essential. A competitive salary and remuneration package is available to the successful candidate. If you are looking to broaden your auditing experience within clinical trials then please call Kristina on 01279 657716 or email Kristina@seltekconsultants.co.uk

Please note that your details will kept entirely confidential, and we will contact you prior to sending your CV to any company.

Job Ref: 8117

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Clinical Study Leader - Pharma - UK to £45K

Clinical Study Leader / Clinical Project Manager

There is an opportunity for a Study Leader to join this dynamic, cutting edge pharmaceutical company. You will be responsible for the execution of Phase 3 and other approved clinical studies, which will include the overall management of clinical studies from study design to clinical report finalisation, ensuring that the studies are conducted to the highest quality standards, are within the agreed budget and are delivered on time.

You will be involved in planning clinical studies with the rest of the team, writing documents (protocols, etc), overseeing monitoring and evaluating and selecting study investigators. You will be involved in investigator meetings as well as managing timelines of protocol development, study conduct, database lock, statistical outputs and delivery of study reports.

You will need to be educated to BSc level and have broad experience monitoring gained over a few years. You must have some experience in managing clinical trials (either in a JrPM role or CRA role). Phase 3 clinical study management would be beneficial.

For more information, please call Kristina on 01279 657716 or email Kristina@seltekconsultants.co.uk

Job Ref: 8114

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Senior CRA - UK - Home Based - to £45K

This global clinical research organisation (CRO) is looking to recruit a Senior CRA in the UK. This company prides itself in being highly scientifically developed, with strong scientific backing. They also have great expertise in the drug development process but focus mainly on CNS, cardiovascular and inflammatory areas.

This CRO has a lower than average staff turnover, and also has a very evolved training system in place which means great career development opportunities for you!.

You will benefit from a supportive career development environment, a competitive remuneration package and a fun and supportive team atmosphere.

You will be responsible for site feasibility, initiation, management and close-out visits for the studies. You will function as Lead CRA for global studies, coordinating CRAs, reviewing monitoring reports etc. when required. You will have the opportunity to mentor and train colleagues and site staff when needed as well as designing monitoring plans and supporting in the design of the protocols and CRFs

Experience of monitoring cardiovascular studies will be essential. In return, you will benefit from a competitive remuneration package and strong career growth potential.

Please apply or for more information email kristina@seltekconsultants.co.uk or call Kristina on 01279 657716

Job Ref: 8113

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Clinical Project Manager - CNS - Europe - to €70K

This leading, global clinical research organisation (CRO) is looking to recruit a Project Manager to manage various CNS clinical research projects throughout Europe. This position has arisen due to expansion, as they have recently won a large number of CNS proposals and are looking for someone to take control of the projects. You can be based in any European country for this role.

This is an expanding, dynamic CRO that has tripled in size in Europe over the last three years. Specialising in the development of oncology, CNS, anti-infective and cardiovascular products they offer a comprehensive range of services to small and medium sized biotech and pharmaceutical companies. This company focuses on its people, offering excellent training and development opportunities and a fun, team focused working environment.

You will lead the clinical team to ensure on-time, on-budget performance, review and approve regulatory and administrative documents from investigator sites, as well as reviewing CRFs and SAE reports.

You will also plan, coordinate, and present at investigators meetings, participate in proposal meetings with potential clients as well as prepare project management reports for clients, project personnel, and the company s management team.

You must be educated to BSc level or RGN, and have a successful background in managing international projects. You can be based in almost any European country.

To discuss this role in confidence, please call Kristina on 01279 657716 or email kristina@seltekconsultants.co.uk

Job Ref: 8108

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Senior Compliance Associate - QA (GLP and GCLP) - UK - to £41K

One of the leading global CROs is looking to recruit a Senior Compliance Associate to join the QA department in the UK.

You will be responsible for GCLP and GLP audits, QA reviews and evaluations and writing of SOPs. You will also provide training of GCLP and GLP regulations.

You will be required to provide input and assistance to Business Development for time and cost proposal development and provide project management oversight for compliance-related tasks and programs.

To be successful in this role you must have experience in a similar position in clinical research, regulatory affairs or a relevant healthcare research position. You must have relevant GLP and GCLP audit work experience ideally gained in a CRO

You will be required to travel up to 40% of the time, and have the motivation and drive to work independently.

A competitive remuneration package is available, as well as the opportunity to work for this exciting, well respected CRO.

For more information, please email Kristina on kristina@seltekconsultants.co.uk

Please note that applying to this role only expresses interest. We will discuss the role and company with you in detail before we send your CV.

Job Ref: 8090

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Senior Quality Assurance Auditor - Clinical Research - Eastern Europe

One of the leading and fastest growing global clinical research organisations (CROs) is looking to recruit Senior Quality Assurance Auditors in Hungary, Czech Republic, Romania, Serbia, Bulgaria or Ukraine . This is an exciting opportunity for you to work for a multinational company that offers the great progression opportunities

As an experienced GCP auditor from any of the countries above, you will be required to conduct three audits per month which include audits of investigator sites and vendors, document/TMF audits, trusted process audits, hosting sponsor audits and co-visit audits with clinical research associates (CRAs).

You will responsible for mentoring less experienced QA auditors, and have the opportunity to act as a lead auditor on team audits and project audits.

You must be able to demonstrate strong and comprehensive knowledge of Good Clinical Practice (GCP) regulations and guidelines and have good experience as an auditor as well as a strong grasp of medical terminology.

A competitive remuneration package is on offer, as well as the opportunity to work for the leading, global CRO.

For more information, please email Kristina, at kristina@seltekconsultants.co.uk

Please note that applying to this job only expresses interest; we will not send your CV to the company without first discussing the role and position in detail with you.

Job Ref: 8085

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