Clinical Project Manager - South East UK - to £55K

This rapidly growing global CRO is urgently looking for a Project Manager to work from their offices in the UK. You will be responsible for overseeing and coordinating the operational aspects of assigned project personnel on ongoing projects. As the primary liaison between the CRO and your clients, you will need to ensure that you have a good understanding of the clients' expectations and that their goals of time, cost, and quality performance are met. This role gives you the opportunity to really get stuck in!! Working on multiple projects at any given time you will be responsible for the cross functional management of the project team! Other responsibilities include budgetary control; coordination and drafting of contracts with external providers and investigators; overseeing the regulatory document collection and submission process; coordination of the data cleanup between clinical operations, data management, biostatistics, and medical affairs; training and mentoring of project managers, and much, much more!

You will be educated to degree level and currently be working within the industry. Project management experience is essential!! Knowledge and experience with FDA/ICH/ISO14155 regulations, drug development and clinical monitoring procedures are necessary. You will be confident and possess strong interpersonal, decision making and strong leadership skills. You will need to be flexible to travel. For your efforts you will be rewarded with an excellent salary and benefits package!

Call Kristina on 01279 657716 and kristina@seltekconsultants.co.uk

Job Ref: 8125

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Senior CRA / CRA II - France - to €40K

This global CRO is looking to recruit a senior CRA in France.

When you work for this company you become part of an expanding, talented team of professionals, committed to quality and passionate about clinical research! This is site co-ordination role in which you will manage all site related activities from protocol review and feasibility through to close out locally in France. Clinical studies will be focused on their Oncology and CNS studies.

Additional responsibilities will include mentoring/coaching junior CRAs, local project management activities and some international liaising at site level - there will also be the chance to take on lead duties within specific projects. This is an excellent opportunity to work for a medium sized CRO that places their employees career progression as their number one priority!

You will have a scientific background and proven track record of start up, initiation, monitoring and close out activities in France. You will be able to work as part of a small team as well as independently with minimal supervision. Flexibility to travel is essential in this role. In return for your experience is a competitive remuneration package and the opportunity to work with a highly experienced and fun team!

For more information, please call kristina on 0044 1279 657716 or email kristina@seltekconsultants.co.uk

Job Ref: 8124

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Senior CRA - Benelux - to €65K

This global CRO is looking to recruit a senior CRA in Belgium or the Netherlands.

When you work for this company you become part of an expanding, talented team of professionals, committed to quality and passionate about clinical research! This is site co-ordination role in which you will manage all site related activities from protocol review and feasibility through to close out locally in Benelux. Clinical studies will be focused on their Oncology and CNS studies.

Additional responsibilities will include mentoring/coaching junior CRAs, local project management activities and some international liaising at site level - there will also be the chance to take on lead duties within specific projects. This is an excellent opportunity to work for a medium sized CRO that places their employees career progression as their number one priority!

You will have a scientific background and proven track record of start up, initiation, monitoring and close out activities in Benelux. You will be able to work as part of a small team as well as independently with minimal supervision. Flexibility to travel is essential in this role. In return for your experience is a competitive remuneration package and the opportunity to work with a highly experienced and fun team!

For more information, please call Kristina on 0044 1279 657716 or email kristina@seltekconsultants.co.uk

Job Ref: 8123

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Study Start-Up Manager - Germany - to €63K

This is a rare opportunity at a small/medium sized global CRO to be a Study Start-up Manager based in Germany

As Start-up Manager you will be the cornerstone of a smooth-running clinical operation and amongst many other responsibilities you will make sure that ethics applications for all on-going projects are approved. You will also be involved in feasibility strategy, helping junior CRAs with finding new sites, line-managing CTAs, dealing with principal investigators and liaising with sponsors for feedback. This rapidly growing CRO is keen to find the right person to keep things on track and make sure that new projects start up without a hitch.

To be successful you will need a strong background in clinical research, with experience in feasibility, site selection and initialtion.This is the perfect opportunity for a CRA who wants career progression but does not necessarily want to be a PM. There is also some flexibility to work from home.

To learn more, or to discuss your application in confidence, please call Kristina on 01279 657716 or email kristina@seltekconsultants.co.uk

Job Ref: 8119

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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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CRA II Serbia - to €30K

This sophisticated and innovative global clinical research organisation (CRO) is looking to recruit a Clinical Research Associate (CRA II) in Serbia . This company prides itself in being scientifically strong with powerful 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 an in-depth training system in place which means excellent career development opportunities for you!

If you are an experienced monitor looking for the next step up in this global, expanding and dynamic company, then please apply or email Kristina@seltekconsultants.co.uk.

Job Ref: 8013

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Freelance CRA - 1FTE or 0.5FTE France

This sophisticated and innovative global clinical research organisation (CRO) is looking to recruit a Freelance Clinical Research Associate France. This company prides itself in being scientifically strong with powerful scientific backing. They also have great expertise in the drug development process but focus mainly on CNS, cardiovascular and inflammatory areas.

They are looking for a 1FTE CRA with CNS experience and 0.5FTE with cardiology experience. The contract will be initially 3 months.

If you are an experienced monitor looking for the next step up in this global, expanding and dynamic company, then please apply or email Kristina@seltekconsultants.co.uk.

Job Ref: 8104

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Senior QA Auditor - CRO - South UK - to £50K

This expanding, global CRO ware looking to recruit a SrQA Auditor to join their offices in the UK.

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. The ideal candidate would have some exposure to device trials and auditing to ISO 14155 requirements. Full training will be provided to candidates with strong ICH GCP auditing experience looking for a move into devices. 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

Job Ref: 8103

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CTA-II / Senior CTA - Poland - Polish Zloty 78,000

An experienced career CTA is required for an expanding, people focused company! In this role, which is based in Warsaw, Poland , you will support project teams by assisting in the internal organisation of phase II-IV European projects across a range of therapy areas that includes oncology. You will be the central point of contact for all team members regarding the study master file and essential documents and will also track and monitor the status of document retrieval, patient recruitment, payments and monitoring visits. This is an administrative position with some travel to site to co-monitor with CRAs.

Who should apply? If you have previous experience of at least six months in clinical research as a CTA we want to hear from you! You must have excellent IT skills and be quality/detail oriented. Good prospects are available for the future and you will be paid well!

Please call Kristina on 0044 1279 657716 or email kristina@seltekconsultants.co.uk for more details

Job Ref: 8101

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CRA - Czech Republic - to Czech Crown 660,000

A Clinical Research Associate (CRA) position has become available in the Czech Republic with an up and coming, people focused drug development company! When you work for this company you become part of an expanding, talented team of professionals, committed to quality and passionate about clinical research! This is a core monitoring role with additional site management responsibility for hospital and clinic based sites across Czech Republic. Clinical studies will be phase II-IV focused and in the oncology, cardiovascular and CNS therapy areas. Additional responsibilities will include start up activities such as feasibility, local ethics/regulatory applications and the preparation of essential documents. Excellent training and development opportunities will be available to you including promotion to Senior Clinical Research Associate SCRA, involvement in mentoring/training junior Clinical Research Associate CRAs and gaining experience of site co-ordination on an international level.

Who are we looking for? You will have a scientific background and a proven track record of monitoring at site in the Czech Republic. You will be able to work as part of a small team as well as independently with minimal supervision. Flexibility to travel is essential in this role. In return for your experience is a competitive remuneration package and the opportunity to work with a highly experienced and fun team! Call Kristina on 0044 1279 657716 or email kristina@seltekconsultants.co.uk

Job Ref: 8100

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Business Development Associate - Proposals - South UK - to £34K

This medium sized global CRO is looking to recruit a Business Development Associate to be part of the proposals team in their UK offices. This is an excellent opportunity to join an expanding company that places the personal development of their employees as a priority.

When you work for this global CRO, you will manage the proposal development process by maintaining deliverables to clients, putting together time and budget estimates and provide analyses for complex, global studies through discussions with senior management, operational teams and sales teams across Europe and globally.

As a Senior BDA you will also train and develop business development associates in procedures, and interdepartmental responsibilities, implement pricing software and coordinate international proposal development and liaison with International Proposal Development.

This is a great job for someone with a working knowledge of the clinical development process and experience in clinical trial time and cost proposal development to move into a more senior position. Good communication and interpersonal skills are essential to the role as well as exceptional IT skills. You will in return profit from a competitive salary package and excellent benefits as well as an annual bonus. The company is very eager to get the right person in as soon as possible so call us now to apply!!!

Please call Kristina on 01279 657716 or email 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: 8092

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Business Development Associate II - BD Department - South UK - to £34K

This medium sized global CRO is looking to recruit an Business Development Associate to be based out of their UK office. This is an excellent opportunity to join an expanding company that places the personal development of its employees as a priority.

When you work for this global CRO, you will provide in-house support to the Business Development Director in maintenance of existing accounts, assist in development of new accounts and client management, coordinate sales activities with internal sources including operations and contract management, as well as support in the preparation of materials for capabilities and proposal presentations, marketing search and etc.

This is a great job for someone with a working knowledge of the clinical development process and experience in a previous business development role (only a small amount of experience is required). Good communication and interpersonal skills are essential to the role as well as exceptional IT skills. You will in return benefit from a competitive salary package and excellent benefits as well as an annual bonus. The company is very eager to get the right person in as soon as possible so call us now to apply!!!

Please call Kristina on 01279 657716 or email 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: 8091

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Senior Compliance Associate - QA (GLP and GCP) - South UK - to £39K

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 GCP and GLP audits, QA reviews and evaluations and writing of SOPs. You will also provide training of GCP 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 GCP 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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