Feasibility and Recruitment Manager – Middlesex

Charlene Dutchman is recruiting for a Feasibility and Recruitment Manager to join a leading biotechnology company based in Middlesex on a 12 month contract.

Responsibilities in this role will include interacting with key stakeholders in study management to establish, and forecast, resources needs for the feasibility team for individual studies. You will also oversee high quality recruitment strategies in accordance with study team needs, and identify training issues to ensure productivity and effectiveness remains high.

To apply for this role you will need proven clinical trial management skills and experience working in a team/matrix environment and detailed knowledge of GCP and FDA regulations and guidelines.

For more information about this role, or to apply, click here

 

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Head of Clinical Trials Contacts – South London

Jim Gleeson at CK Clinical is exclusively recruiting for a permanent Head of Clinical Trials Contacts for the Enterprise Unit of The Institute of Cancer Research at their site in Sutton, South London.

The Institute of Cancer Research is one of the world’s most influential cancer research organisations and is ranked as of the UK’ top academic research centres. As Head of Clinical Trials Contracts you will be required to manage the Clinical Contracts Team which is responsible for all contractual agreements relating to clinical trial research, as well as be the primary contract for all clinical transactions.

Further responsibilities in this role include:

  • Management of all aspects of the clinical trial contracting process with commercial and non-commercial institutions for studies sponsored and managed by or co-ordinated or hosted by ICR and RM ensuring the proper review and negotiation of clinical trials and associated contracts
  •  Identification and meeting of the expectations of stakeholders and partner organisation in performing the clinical trials contracting function

To apply for this position you should have a legal or science qualification and have extensive experience of working in a contract function for clinical trials. In return there is a generous salary and benefits package offered.

For more information on this position, or to apply, click here 

 

 

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Senior Drug Safety Specialist – Cambridgeshire

Hendre Moolman is recruiting for a Senior Drug Safety Specialist to join a company in the pharmaceutical industry in a permanent role in Cambridgeshire.

Responsibilities

As Senior Drug Safety Specialist the main purpose of your role would be the overall coordination of serious adverse event (SAE) processes and database activities and the PVG coordination of sponsor and investigator meetings.

Further responsibilities of this Senior Drug Safety Specialist position will include:

  • Set up and maintain accurate data within the SAE tracker for all assigned projects
  • Set up and QC of data entry into safety database
  • Review SAE reports for completeness, clinical consistency and agreement with source documents
  • Identify and send SAE queries to investigator sites either directly or through CRAs. Prepare Physician Assessment Form and ensure that medical monitor assessments of SAE documents are completed and distributed according to project requirements
  • Coordinate SAE activities for assigned projects, including study start-up, maintenance and close-out activities, SAE reconciliation, budget tracking and forecasting for assigned studies
  • Produce and maintain accurate status and metric reports for assigned projects
  • Prepare and QC patient SAE narratives
  • Produce accurate SAE data for reporting purposes (including regulatory reporting)
  • Prepare and submit expedited safety reports and manage the reporting process
  • Promptly advise the Manager/Associate Director/Director, Pharmacovigilance of any significant safety and regulatory concerns
  • QC safety-related paper documents/electronic data/database entries prepared by others
  • SAE reconciliation
  • Review Data Management listings, database reports, and validation checks
  • Adhere to current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues.
  • Perform internal audit activities for departmental processes and procedures
  • Assist with external audit activities
  • Develop supervisory and mentoring skills for standard SAE processing, study set-up, maintenance, close-out and narrative generation

Qualifications

As Senior Drug Safety Specialist you will have the following qualifications, skills and experience:

  • Bachelor's degree in Life Sciences or Nursing
  • Proven medical/clinical experience or clinical/safety experience doing SAE processing 

Benefits

As Senior Drug Safety Specialist you will be joining a global pharmaceutical company based in the South East.

  • You will be working with a global company
  • You will have a competitive salary
  • Permanent roleHendre Moolman - Pharmacovigilance Recruitment

How to apply

Apply online now

For more information or to apply for this Senior Drug Safety Specialist position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk.

Are you looking for a job in Drug Safety?

Click here to view all CK Clinicals Drug Safety jobs

GSK hope for strong drug pipeline in 2013/2014    Novartis expects to develop 14 new blockbuster drugs by 2017

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Senior Statistician – Switzerland

Mylene Paumier at CK Clinical is recruiting for a Senior Statistician to join a global pharmaceutical company at their site based in Switzerland on a permanent basis.

Responsibilities

As Senior Statistician, your responsibilities will include

  • All statistical tasks of individual clinical trials.
  • All statistical tasks on the assigned clinical trials, and perform these tasks with a high level of independence e.g.: clinical trial design/planning, analysis plan, reporting activities including exploratory analyses and additional analyses to support publications, plus statistical consultation during the running phase.
  • May be assigned to lead a small project or parts (e.g. indication) of a project, initially under the guidance of a more experienced statistician, but with increasing autonomy and accountability.
  • Track clinical trial/allocated project activities and milestones.
  • Ensure timeliness and adequate quality for the assigned trials and project tasks.
  • Participate in or lead non-clinical project activities as needed.
  • Establish and maintain sound working relationships and
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    effective communication within the Clinical Trial Team/International Clinical Team

Qualifications

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

  • At least Masters Degree in Statistics (or equivalent degree) with experience or PhD with experience.
  • Fluent English (oral or written).
  • Experience in all tasks of a Trial Statistician.
  • Proven knowledge in Statistics and its applications to clinical trials. Proven knowledge of drug development and HA guidelines.
  • Background medical knowledge, preferably in relation to the specific therapeutic area.
  • Proven knowledge of statistical software packages.
  • Good communication and presentation skills. Good team player

 Mylene Paumier at CK Clinical is recruiting for a Senior Statistician in SwitzerlandHow to apply

Apply online now

For more information or to apply for this Senior Statistician position, please contact Mylene Paumier on +44 (0)207 470 5672 or email: mpaumier@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.  Please quote reference CL25702 in all correspondence.

Looking for a new job as a Statistician?

Click here to see our latest Statistician jobs

Pharmaceutical Jobs    Pharmaceutical jobs in Europe and the UK

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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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Senior Data Manager Job in UK

Priya Mukherjee at CK Clinical is currently recruiting for a Senior Clinical Data Manager to join a niche clinical trials company based in the UK.

The role:

As Senior Data Manager, you will be expected to contribute significantly to the EDC and project management aspects of Data Management, including management, development and review of EDC databases, both from an internal and external vendor perspective. In addition, you will be the Data Management lead on a number of projects, having the ability to work as part of the project team as well as on your own initiative.

The ideal candidate:

Priya is looking for candidates who have implemented and worked with a number of Electronic Data Capture (EDC) systems and providers and must be able to demonstrate experience gained within EDC Data Management. You will have a broad knowledge of the Pharmaceutical Industry, associated regulations and a full understanding of the role of the Contract Research Organisation (CRO) in Clinical Research.

Experience of leading complex Oncology studies is also highly desirable and you must have managed the EDC Data Management aspects of a number of large and complex studies simultaneously, using your excellent management and communication skills across all disciplines and at all levels to ensure success.

Interested applicants will have a flexible approach to their work, be self-motivated, have excellent organisational skills and be able to motivate and direct others within a project team environment. Good problem solving and decision making skills are essential, as is the ability to help facilitate the development of EDC Data Management skills in Data Managers and Data Associates.

How to apply:

For more information or to apply for this Senior Data Manager position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23017 in all correspondence.

Not quite what you’re looking for? Click here to search our current Data Manager jobs in the UK and EU now.

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Clinical Trials Coordinator Job – London, UK

This is an excellent and rare opportunity to join a Clinical Research Organisation based in Central London, UK.

Responsibilities:

  • You will lead in the day to day management of Clinical trials within our client’s Advanced Therapies Centre (ATC) in the delivery of high quality clinical research trials sponsored by commercial companies and potentially all other agencies.
  • This post will be key in leading and co-ordinating the clinical trial staff in the growing ATC and increasing accrual of patients into clinical trials.
  • Central to this role is maintaining an active caseload in identifying eligible patients at Multidisciplinary Team (MDT) meetings and clinics.
  • You will assist in the consent process with patients including the explanation of standard and research treatment, risks, benefits and side effects.
  • You will be responsible for randomisation, completion of case report forms (CRF’s) and the maintenance of accurate records according to GCP (Good Clinical Practice) and UK Statutory Instrument.
  • You will also have responsibility for the organisation of investigations, tracking follow-up of patients with our client’s Clinical Assistants and Investigators.
  • Assist with regular submission of data to clinical trials centres, the Clinical trials manager and the funding stakeholders.
  • You will be expected to be proactive in educating clinical staff in the specifics of running clinical trials. Willingness to work flexibly is an essential aspect of this post.

Person Specification:

  • Degree in life sciences
  • Experience of working within clinical research and in the recruitment of cancer patients into trials</li>
  • Proven experience in mentoring/coaching staff
  • Proven Oncology and  clinical research experience
  • Proven personal and leadership experience
  • Proven experience of leading staff training and development
  • Proven experience of basic management issues in team working and motivation
  • Proven experience in implementing change
  • Familiarity with research governance
  • Participation in consent process for patients entering clinical research Experience of working independently and as part of a team
  • Experience of managing complex information or projects
  • <li>Competent in using Microsoft Office software for storing/retrieving data

Apply Now

For more information or to apply for this Clinical Trials Co-ordinator role, please contact Susan Murray on 01 438743047 or email smurray@ckclinical.co.uk.

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Clinical Research Associate Job – London, Brighton and Southampton, UK

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Clinical Research Associate Job – London, Brighton and Southampton, UK

An exciting opportunity for a Clinical Research Associate on a six month contract with a major global pharmaceutical company. This is a field based position, you will monitor sites in London, Brighton and Southampton.

Your main responsibilities as a Clinical Research Associate will include:

  • To collaborate in the identification and drive the selection and monitoring of investigator sites with supervision and input from other cross functional groups, in compliance with company SOPs, ICH GCP and the UK Statutory Instrument, so that site performance targets are achieved and that the company’s image with its external customers is enhanced.
  • Data Monitoring with supervision
  • Management of investigator sites (Selection, initiation, monitoring and close-out) with appropriate support
  • Data Quality
  • Reporting
  • Documentation

 

Apply Now

For more information or to apply for this Clinical Research Associate position, please contact  Susan Murray at CK Science on 01438 870 027 or email smurray@ckclinical.co.uk. Please quote reference CL21389 in all correspondence.

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Director of Clinical Development – Greater London

Our client, a rapidly expanding global pharmaceutical company, is currently seeking a Director of Clinical Development to join their team based in Greater London.

This is a high profile Clinical Development role in which you will oversee and manage global or regional development programs or multiple multinational phase II/III clinical trials in order to achieve a high quality product for the marketplace and business success for the organisation.

You will be the point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters. As Director of Clinical Development, you will also be responsible for both overseeing the management and performance of CROs, and for ensuring the high quality of the products for the business.

The successful individual will be educated to MD, PhD or DPharm level with demonstrable hands on experience leading a multi-country, oncology clinical program.

This is a very rare opportunity to join an expanding pharma company and to take your career to the next level.

If you are interested in finding out more about this opportunity please contact Ben Traies at CK Clinical on 01438 743047 or email btraies@ckclinical.co.uk . Alternatively, please click here.

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the clinical and pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

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GSK Signs Nicotine Vaccine Deal

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As reported in a recent Financial Times article, it has been announced that GlaxoSmithKline has paid Nabi Pharmaceuticals an upfront fee of $540 million, allowing them to both license the nicotine vaccine, NicVax, and to develop the next generation of nicotine vaccines.

Nabi began testing the nicotine vaccine 4 years ago as a result of funding from the National Institutes of Health. Nabi have now signed a $540million deal with pharmaceuticals giant, GlaxoSmithKline. As a result, NicVax has now entered the first of two Phase III trials. The vaccine is designed to both stop the nicotine in tobacco entering the brain, and to help create antibodies that bind to nicotine molecules, preventing them from passing from the blood to the brain.

Nabi also believes that this innovative vaccine could also be used to help prevent smoking relapse. Relapse rates can be known to be as high as 90% during the first year after the smoke quitters. In early trials it has been found that those vaccinated with NicVax were 3.5 times more likely not to be smoking again after a year. Jean Stephenne, President of GSK Biologicals, said that if approved, “This smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent; a habit that is well documented to be very hard to stop permanently”.

This deal highlights a move by the large pharmaceutical companies to expand their horizons by moving further into the field of vaccines, indicating that there is the potential for many jobs to be created within this field. To view CK Clinical’s latest pharmaceutical job vacancies, please click here.

About CK Clinical

Here at CK Clinical, we pride ourselves on our honest and supportive approach. Our team of specialist recruiters and career consultants are here to help you achieve your career ambitions within the pharmaceutical industry. We can actively offer you careers advice, help with writing your CV, assistance with your interview preparation and provide you with up to date information about the industry.

Keywords: GSK jobs, pharmaceutical jobs, clinical research jobs, drug safety jobs, data management jobs, ck clinical

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