Quality Compliance Associate - UK to £27K (£28K OTE)

One of the largest and most recognised manufacturers of life science research products has created a new opportunity within its European compliance team. The role will be office based in the South West of the UK.

This is a dynamic and challenging role, which involves understanding the evolving compliance offer, its role as a sales tool and delivering a compliance support service to customers by adopting a consultative approach. You will be part of a small UK team supporting all compliance issues, you will need to liase with a variety of other departments and take responsability for handling to conclusion queries.

The successful candidate will be a life science graduate with great attention to detail and a tenacious character. Previous experience of using SAP based systems would be helpful however full training and support can be provided to ensure you are confident in the role. To discuss this great opportunity in detail contact us soon.

Job Ref: 8138

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Senior Drug Safety Associate - South UK - to £35K

This is an exciting opportunity for a Drug Safety Associate to join one of the leading international clinical research organisations (CROs).

You will be involved in reviewing SAE information from investigator sites and AEs from post marketing sources for completeness and regulatory compliance, as well as perform QC reviews of safety reports and preparing safety data reports for submissions to clients.

Because of the level of seniority of the position, you will be in contact with clinical operations personnel and clients to ensure compliance with safety and pharmacovigilance SOP as well as mentoring safety associates and other members of the safety and pharmacovigilance team.

Excellent training is provided and there is plenty of scope for development into more senior positions.

Who are we looking for? You will have a proven track record of working in drug safety and pharmacovigilance. A strong scientific or nursing background is essential for success in this role (equivalent experience will be considered).

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

Please note, that applying for this opportunity only expresses interest; we will discuss the role and company in detail with you before your CV is sent to the company.

Job Ref: 8083

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Clinical Research Associate - UK - to £35K

This is a varied and challenging Clinical Research Associate (CRA) or Senior Clinical Research Associate (SCRA) position with an expert consultancy company!

Broaden your scientific knowledge within clinical research by working on novel studies in phase I-II and Proof of Concept stages of development! When you work for this small but expanding speciality company you take on a broad set of responsibilities ranging from protocol and Investigator Brochure development through to business operations and training!

You ll gain broader exposure in this company than with any other business in the clinical research industry! Based from the office in East Anglia you will work as part of small, highly experienced and dedicated team to deliver clinical projects on time and within budget.

In this small company the CRA and SCRA roles involve site management and monitoring in the UK; study design and set up; the development of regulatory documentation such as investigator brochures, protocols, informed consent and clinical study reports; and business operations activities to include client relationship management, business development and marketing. At the CRA level you will focus mainly on the site management and co-ordination activities and at SCRA level you will be more involved in local project management activities and the development of regulatory documentation in addition to managing sites.

Who are we looking for? With a strong scientific background you will have a proven track record in the management and monitoring of UK sites. Exposure to phase I/II and Proof of Concept is an advantage. Your experience could come from academia, CRO or pharmaceutical/biotechnology company environments.

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

Job Ref: 8132

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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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