Global Clinical Trials Manager – Hertfordshire

Jim Gleeson at CK Clinical is recruiting for a Global Clinical Trials Manager to join a major pharmaceutical company at their

site in Hertfordshire on a six month contract.

Responsibilities:

This Global Clinical Trials Manager role is a leadership role overseeing large scale clinical trials from planning to close-out ensuring timelines, budgets and ICH / GCP regulations are fully complied with.

Your responsibilities will include:

  • Development of operational plans covering monitoring strategies, risk mitigation, budgets, site selection and clinical supplies management
  • Leadership of high performing operational teams
  • Development and management of clinical study budgets
  • Leadership of the development of Protocol Feasibility Questionnaires, Site Feasibility Questionnaires and Patient Recruitment Plans
  • Planning and management of the IMP and non-clinical supply chains
  • Proactive management of study level recruitment
  • Management and auditing of third party vendors (CROs, Labs, IVRA etc)
  • Ensuring adherence to ICH / GCP and SOPs

Experience and skills required:

The successful candidate for this Global Clinical Trials Manager will have the following skills and experience:

  • Strong experience of the management of global clinical trials
  • Management of CROs, budgets and IMP supplies
  • Ability to lead global teams
  • Excellent GCP / ICH knowledgeJim Gleeson - Senior Recruiter at CK Clinical

How to apply:

Apply online:

For more information or to apply online for this Global Clinical Trials Manager please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL25184 in all correspondence.

 

Not quite what you’re looking for? Click here to register your CV with CK Clinical today.

Once registered, one of our specialist Pharmaceutical Recruitment Consultants will be in contact to discuss your requirements and any relevant pharmaceutical jobs we are recruiting for at the moment. Good luck with your job hunt.

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GSK buys long term partner Human Genome Science

Reuters have reported that GlaxoSmithKline is to acquire its long-time partner Human Genome Science for £1.92 billion pounds.

This new acquisition will fit in well with with GSK’s long-term strategy of delivering sustainable growth, simplifying GSK’s business model, enhancing R&D returns and deploying capital with discipline.

Also now they have the complete ownership of BENLYSTA, albiglutide and darapladib, GSK can simplify and optimize R&D, commercial and manufacturing operations to advance these products most effectively and efficiently while securing the full potential long-term value of the assets.

Sir Andrew Witty, Chief Executive Officer of GSK, said: “We are pleased to have reached a mutually beneficial agreement with HGS on friendly terms and believe the combination of GSK and HGS represents clear financial and strategic logic for both companies and our respective shareholders….This is a natural next step in our nearly 20-year relationship with HGS, and we look forward to working with HGS to integrate our businesses and to realizing the full value of BENLYSTA, albiglutide, and darapladib for the benefit of patients and our shareholders.”

 

Click here to see our latest clinical jobs in the UK and Europe

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Australian scientists make IVF discovery

The Telegraph has reported that a study of more than 50,000 births in Australia and New Zealand found the death rate of babies conceived using in-vitro fertilisation is significantly reduced when only one embryo is implanted.

The study found the difference was more pronounced in births involving fresh rather than frozen embryos. Births involving two fresh embryos had a 74 per cent higher risk of perinatal mortality than births following fresh single transfers.

The study leader, Elizabeth Sullivan, said the findings showed that Australia’s policy of promoting single embryo implants had helped to reduce infant mortality rates.   Countries such as the United States and the United Kingdom have rates of single embryo transfers of between 12 and 15 per cent, compared with 70 per cent in Australia.

 

Are you looking for a new role in clinical research? Click here to see our latest clinical research jobs?

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AstraZeneca to develop asthma treatment

As reported by PharmaTimes, AstraZeneca has signed an exclusive global licence deal with USA-based Rigel Pharmaceuticals for a potential new treatment for chronic asthma.

The drugs is Rigels R256, it is being investigated as a treatment for moderate to severe chronic asthma and in preclinical research has been shown to reduce airway inflammation and improve lung function.

AstraZeneca will be responsible for beginning first-in-human clinical studies for R256 and have exclusive rights to commercialise the drug around the world.  Rigel will receive an upfront fee of $1 million with an additional $8.25 million in early milestone payments. In total, the deal could be worth up to $100 million.

Mene Pangalos, head of innovative medicines at AstraZeneca, said “there remains a need for more targeted therapies for moderate to severe chronic asthma”.

Looking for a job in the Pharmaceutical Industry?Click here to search our pharmaceutical jobs online now.

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GSK partner the University of Cambridge in drug discovery

The Business Weekly has reported that the University of Cambridge has agreed to a new collaboration with GlaxoSmithKline to advance drug discovery and the development of new medicines.

The University and GSK will work along with scientists from other organisations at Stevenage Bioscience Catalyst (SBC), the UK’s first open innovation bioscience campus, located near with GSK’s R&D centre.

This bioscience park provides an independent scientific community allowing scientists to build relationships across organisations and share their expertise and knowledge. Therefore those based at the park share access to specialist skills, scientific equipment and expertise. This should stimulate innovation and speed up the discovery and development process.

Patrick Vallance, president of pharmaceuticals R&D at GlaxoSmithKline, said: “This open innovation approach is enabling scientists who might not ordinarily have interacted to build relationships, share ideas and seek advice…This environment provides us with an opportunity to stimulate research and translate science into the discovery of new medicines for patients.

Click here to see our latest clinical jobs!

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Meet Moin Din – Medics Recruitment at CK Clinical

Meet Moin Din, Senior Recruitment Consultant at CK Clinical. Moin specialises in recruiting for Medics and senior level appointments within the Pharmaceutical, CRO, Biotechnology and Healthcare industries.

Moin covers all permanent, interim and contract recruitment within CK Clinical’s Medic Recruitment function. To find out more, please watch Moin’s short video below:

Looking for a Medic job in the Pharmaceutical Industry?

Click here to search our current medic jobs online now.

Alternatively, please call us on +44 (0)1438 743 047 or email info@ckclinical.co.uk.

Click here to meet the rest of the CK Clinical recruitment team.

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CK Clinical to Exhibit at the DIA EuroMeeting in Copenhagen

CK Clinical, the specialist UK and EU pharmaceutical recruitment consultancy, is proud to announce that we will exhibiting on stand 714 at the 2012 DIA (Drug Information Association) 24th Annual EuroMeeting 2012.

About the EuroMeeting 2012

The EuroMeeting which is taking place 26th to 28th March at Copenhagen, attracts more than 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, clinical research, regulatory agencies, health ministries, patients’ organisations and universities. The EuroMeeting also offers:

  A neutral, global forum featuring over 120 sessions attracting
more than 3,000 professionals involved in the development of
medicines from more than 50 countries
•  Speakers from the European Medicines Agency, the European
Commission, the FDA and other regulatory agencies from
European countries and other regions of the world
•  More than 200 exhibitors on one of the largest exhibition floors
in Europe
•  Unparalleled multi-disciplinary networking opportunities
•  Student and professional poster sessions
•  Active involvement of patient organisations
•  Pre-conference tutorials led by expert faculty
•  Hot topic sessions

To find out more about the EuroMeeting and to register your attendance, please click here.

Visit CK Clinical on Stand 714

So, if you are looking for a new position in the pharmaceutical industry, or are looking to expand your team, please come along to stand 714 to say hello. You could even be in with a chance of winning a Kindle by entering your business card into our prize draw!

Book an Appointment

Jonathan, Ben, Priya and Moin from CK Clinical are all available to book appointments with throughout the duration of the EuroMeeting. To find out more about them, please click on the links below which will direct you to their LinkedIn profiles. To book a meeting, please contact them directly on the details below. Thank you!

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Senior Statistical Programmer Job in South East UK

Priya Mukherjee at CK Clinical is currently recruiting for a Senior Statistical Programmer to join a Contract Research Organisation based in the South East of the UK.

Senior Statistical Programmer Job Description

As Senior Statistical Programmer, you will provide technical expertise for the conduct of clinical trials, where you will act as an internal subject matter expert in specific areas providing technical support and expert advice, and work independently to support various programming activities related to the analysis and reporting of clinical study data.

Further responsibilities of this Senior Statistical Programmer job will include:

  • Deliver best value and high quality service
  • Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.
  • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget
  • Monitor project resourcing, project budgets, and identify changes in scope
  • Interact with Sponsors as the key contact with regard to statistical programming issues
  • Provide technical support and advice to the internal team
  • Check own work in an ongoing way to ensure first-time quality
  • Ensure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standards, WSOPs/Guidelines, ICH-GCP and/or other international regulatory requirements are performed.
  • Coordinate project start-up activities, including Unix/PMED project area set-up, creation of global programs (e.g., setup.sas, formats.sas, etc.), tracking spread sheets, and required documentation.
  • Assist in the production and QC of analysis plans, produce and QC TLF mock-shells, derived dataset specifications, programming specifications, and other process supporting documents.
  • Use efficient programming techniques to produce and/or QC derived datasets tables, figures and data listings.
  • Create standard macros and applications to improve the efficiency of the department.
  • Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
  • Proactively participate in and/or lead process/quality improvement initiatives
  • Work closely with the Quality Management Groups (QMG) to ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required
  • Develop wider knowledge of SAS and other relevant programming languages and processes within the GRO, Biostatistics, and Medical arenas.

As Senior Statistical Programmer you will have the following qualifications, skills and experience:

  • A BSc Degree in a Life Sciences, Computer Science, Mathematics, Statistics OR Equivalent
  • proven experience of working in a Pharmaceutical/CRO/Biotechnology organisations
  • A proficient user of SAS and hold knowledge of the programming and reporting process
  • The ability to learn new systems and function in an evolving technical environment
  • The ability to successfully work together within a team as well as independently

How to apply:

For more information or to apply, please contact Priya Mukherjee on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk.

Click here to search our Statistics jobs in the South East now.

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Biotherapeutics on the Rise in the UK

As reported by Genetic Engineering and Biotechnology News, there has been a growth in the development and manufacturing of biotherapeutics in the UK. In addition, the UK is showing a strong pipeline for biopharmaceutical development.

At the recent biotech conference, bioProcessUK, Head of bioProcessUK at the HealthTech and Medicines Knowledge Transfer Network, Mark Bustard stated, “This year we estimate at least 500 new jobs have been created in bioprocessing . Our current government is recognizing that we have to encourage new types of industry. So it’s investing in bioprocess manufacturing with Technology Strategy Board funding of £8.5 million to fund regenerative medicine projects alone.”

Biotherapeutics in the UK:

A number of companies are looking at increasing their capacity for the development and manufacturing of biotherapeutics in the UK. Including, GlaxoSmithKline, Lonza, Fujifilm Diosynth Biotechnologies and Eden Biodesign.

Biopharmaceutical development in the UK:

According to Dr. Bustard, the U.K. has at least 205 innovative medicines in development with companies such as Reneuron making good progress with its cellular therapy to treat stroke patients.

Click here to search our UK biotechnology and pharmaceutical jobs online now.

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Merry Christmas and a Happy New Year!

All of us at CK Clinical would like to wish all of our clients and candidates a very Merry Christmas and a Happy New Year.

We have really enjoyed working with you throughout 2011, and look forward to working with you in 2012.

 

CK Clinical Christmas Office Hours

Please note that the CK Clinical office will be open between the hours of 9.00am and 2.30pm on 28th, 29th and 30th December with normal working hours of 9.00am – 5.30pm commencing on 3rd January 2012.

 

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