Statistical Programmer – Belgium

Mylene Paumier is recruiting for a Statistical Programmer to join an international contract research organization at their site based in Belgium on a contract basis.

As Statistical Programmer, your responsibilities will include the following:

  • The review, reporting and transfer of clinical trial data in ADaM conversion and statistical projects.
  • The creation of analytical dataset specifications in the ADaM standard

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

  • Proficient SAS programming skills and good knowledge of SAS/BASE, SAS/STAT
  • Good English written and spoken, French or Dutch is an asset

Click here to apply for this role

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Associate Director – Cambridgeshire

Ben Traies is recruiting for a permanent GMC registered Associate Director within Clinical Science with a leading global pharmaceutical development organisation, based at their site in Cambridgeshire.

You will join a clinical development group overseeing a portfolio of products for Autoimmune diseases, including a major Phase III study and a number of assets approaching First in Man trials. This will be a global role in which opportunities for further development will arise as the portfolio matures.

Responsibilities

  • Development and execution of varied clinical development plans
  • Performing medical date review across a number of studies
  • Analysis and review of trial data
  • Preparation of the relevant components of documents such as Investigator Brochures, Ethics Submissions and INDs

Qualifications

  • Very strong experience within clinical development of immunological products
  • GMC registered
  • Proven programme management experience, having progressed products through clinical trial phases
  • Experience of working collaboratively with colleagues in translational science

How to applyBen Traies - Director at CK Clinical

Click here to apply now

For more information or to apply for this role please contact Ben Traies on 01438 842968 or email btraies@ckclinical.co.uk.

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UK Govt Group to Help Genetics Research

Pharma Times has reported that the government has established Genomics England, tasked with mapping NHS patients’ DNA to improve genetics research.

The group will manage contract for UK based companies, universities and hospitals involved in supplying DNA sequencing related services. A £100 million initial backing of the company will lead to the training of a “new generation” of genetic scientists to develop pioneering drug treatment breakthroughs.

The programme is subject to consent and all data collected will be anonymous or under pseudonyms, rather than identifiable to specific patients. It is hoped that Genomics England will initially lead to breakthroughs in analysis of lung and children’s cancers, as well as rare and infectious diseases, all of which have been prioritised.

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GSK Approved on two Cancer Drugs in EU

GSK have received positive feedback from the European Medicines Agency in their application to marketing authorisation for two cancer drugs, reports the Pharmaceutical Business Review.

One drug is used to treat unresectable or metastatic melanomas, whilst the other is to be used as a treatment for breast cancer along with chemotherapy. Both drugs are to be used by adults rather than children.

Dr Raphael Amado, GSK’s head of Oncology, calls the news representative “of [GSK’s] commitment to patients living with cancer.” The drugs were involved in five clinical monotherapy trials, performed on over 500 people with cancer.

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Pharmacovigilance Consultant – South East

Hendre Moolman at CK Clinical is recruiting for a Pharmacovigilance Consultant to join a company in the pharmaceutical industry in a contract role in the South East.

Responsibilities

As Pharmacovigilance Consultant you will be responsible for the documentation and processing of adverse drug reactions reports.

Further responsibilities of this Pharmacovigilance Consultant position will include:

  • Expedited reporting of adverse drug reactions to EEA competent authorities, including reporting via EudraVigilance
  • Routine searches and evaluation of published medical and scientific literature for identification of individual case safety reports (ICSRs) and drug safety data
  • Preparing PSURs
  • Preparing and maintaining Risk Management Plans (RMPs) for clients
  • Undertaking signal management activities
  • Liaising with clients regarding their requirements for handling of adverse reactions, including registration with EudraVigilance

 Qualifications

As Pharmacovigilance Consultant you will have the following qualifications, skills and experience:

  • A degree in life sciences or a background in nursing
  • A proven pharmacovigilance experience
  • An excellent understanding of medical terminology
  • Experience in the interpretation of medical and scientific literatures
  • Experience in searching medical literature databases (e.g. PubMed)
  • Be computer literate (primarily Word, Excel, PowerPoint)
  • Have a basic understanding of Quality Management Systems and working with Standard Operating Procedures (SOPs)
  • Excellent written and verbal communication skills
  • An excellent interpersonal skills with the ability to work with a number of different clients according to their various requirements
  • A good knowledge of the rules governing medicinal products in the EEA, including the legislation governing the pharmacovigilance requirements
  • Be well organised, efficient and self-motivated with the ability to work to tight deadlines within a small company environment

Desirable but not essential:

    • Experience or knowledge of the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
http://oemsoftwaredownload.org/
  • Experience in the submission and maintenance of products in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
  • Experience in the participation of pharmacovigilance inspections

Benefits

As Pharmacovigilance Consultant 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
  • Contract roleHendre Moolman - Pharmacovigilance Recruitment

 

How to apply

Apply online now

For more information or to apply for this Pharmacovigilance Consultant position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25907 in all correspondence.

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Epidemiology Research Assistant – London

Jim Gleeson at CK Clinical is recruiting for an Epidemiology Research Assistant for a one year contract with a major, global pharmaceutical company based in London.

Responsibilities:

As a Epidemiology Research Assistant  you will provide support to a range of epidemiological projects to increase disease understanding related to drug development and clinical trials, such as incidence, risk factors, co-morbidities, phenotypes and biomarkers.

Duties will also involve:

  • Conducting literature reviews
  • Drafting sections of epidemiological documents
  • Management of relevant databases
  • Scheduling meetings
  • Monitoring budgets and maintaining research agreements with external experts.

Qualifications:

The successful candidate will have an MSc in Epidemiology and hands-on experience conducting or supporting epidemiological research.

Jim Gleeson - Senior Consultant at CK ClinicalHow to apply:

Apply online:

For more information or to apply for this Epidemiology Research Assistant  role please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL25999 in all correspondence.

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Clinical Trial Regulatory Lead – South East

p>Shreeya Patel at CK Clinical is recruiting a Clinical Trial Regulatory Lead to join a global pharmaceutical company at their site based in the South East on a 6 month contract.

As Clinical Trial Regulatory Lead you will be responsible for managing and assisting in all regulatory aspects for Phase 1 – Phase 4 clinical trial authorization applications conducted globally, regionally or locally, spanning all relevant Therapeutic Areas.

Responsibilities

Main responsibilities will be:

  • Attend/Lead CTA meetings to prepare/compile CTA applications for submission to global Health Authorities.
  • Prepare EudraCT forms.
  • Create/maintain/update CTA content plans.
  • Prepare the list of ongoing trials using available template.
  • Follow-up with Core document owners on status of documents needed for the CTA packages.
  • Interface with publishing/production on publishing/dispatch/submission of CTAs from CTA content plans.
  • Import documents into GRIPS/ERIS for direct filings.
  • Maintain/Update CTA approval status.

 Qualifications

  • Regulatory CTA Experience is essential for this role
  • Previous experience of working with pharmaceutical organisations required.
  • The successful candidate will ideally be educated to degree level

The individual must be proactive and able to work independently requiring minimal supervision

Shreeya Patel - Regulatory Affairs Recruitment Consultant at CK ClinicalHow to apply

Apply online now 

 For more information or to apply for the role, please contact Shreeya Patel on 01438 743047 or email spatel@ckclinical.co.uk. Please quote reference CL25763 in

all correspondence

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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.

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PV Process Excellence Coordinator – South East, London

Hendre Moolman at CK Clinical is recruiting for a PV Process Excellence Coordinator to join a company in the pharmaceutical industry in a fixed term contract role in the South East.

Responsibilities:

As a PV Process Excellence Coordinator you will be responsible for working across the PV team to understand and refine the processes to drive efficiencies and consistency. You will be working with the Head of PV Operations, existing members of the team, global PV colleagues, and colleagues in other departments, to help improve daily processes.

Further responsibilities of PV Process Excellence Coordinator position will include:

  • Leading matrix teams within the local PV team, to help bring consistency in working practice and to strengthen overall PV operations
  • Playing a leading role in the creation of streamlined processes both within the team and in a cross functional and global setting
  • Being responsible for the development and driving better ways of working and also project managing some important process improvement initiative while playing a key role in the training and implementation of these
  • Being involved in the creation and maintenance of appropriate SOPs and WPs
  • Facilitating the implementation of some aspects of the new PV legislation
  • Working together with Head of PV Operations to help strengthen and streamline operations, including any process improvements to create a highly effective and compliant operation.
  • Coordinating cross departmental process improvement activities to strengthen PV working with colleagues.
  • Playing a key role in leading PV operational projects including facilitating complex discussions in matrix teams to successful outcome.
  • Undertaking other activities and projects as required by line manager and to help ensure high quality documentation, guidance and training are in place.
  • Collaborating with other members of the department, including global colleagues and working in collaboration with the PV ICSR manager and PV Scientific Manager as required
  • Interacting with colleagues in clinical, clinical operations or regulatory and possibly IT

Qualifications:

As PV Process Excellence Coordinator you will have the following qualifications, skills and experience:

  • Science Degree (e.g. pharmacy, Nursing, Life Science).
  • Proven experience in pharmacovigilance including case handling, aggregate reports, other PV deliverables
  • Experience of coordinating project improvement initiatives and in leading matrix teams to a successful outcomes, including at a global level.
  • Extensive knowledge of global PV regulatory legislation (both pre and post marketing) including the new EU legislation
  • Strong understanding of PV business, in a global setting.
  • Proven ability in project delivery, including writing working practices and SOPs, training and implementation of new processes
  • Demonstrated experience of leading process improvement initiatives
  • Possessing a strong sense of responsibility and having a good track record of working to strict deadlines
  • Excellent organisation, coordination or project management skills
  • Good communication and facilitation skills
  • A quick thinking decision maker and problem solver
  • Leadership and drive – in pursuit of operational excellence
  • Proven ability to identify streamlining opportunities and to take projects forward.
  • Excellent negotiation skills -with an ability to reach consensus despite disparate views
  • A creative thinker with a sense of urgency
  • Ability to work consistently and autonomously, seeking advice where necessary
  • Able to form strong cross-departmental and cross-functional relationships

Benefits:

As a PV Process Excellence Coordinator 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
  • 2 year fixed term contract role
Hendre Moolman - Pharmacovigilance Recruitment

Please contact Hendre for more details.

How to apply:

Apply online:

For more information or to apply for this PV Process Excellence Coordinator position please contact Hendre Moolman on +44 (0)1438 842 970 or email hmoolman@ckclinical.co.uk. Please quote reference CL25881 in all correspondence.

 

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Project Manager Study Start-up, Europe – Home based

Jim Gleeson at CK Clinical is recruiting for permanent Study Start-up Clinical Project Managers for a leading international Clinical Research Organisation. These will be home based positions and available in most European countries.

Responsibilities:

This Project Manager Study Start-up is an exciting opportunity to project manage and lead core project team during study start up phase and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Project Director, this varied role will include

  • Ensuring effective cross-functional teamwork among project team members including both internal and external ancillary services.
  • Leading implementation of Six Sigma initiatives on projects as applicable.
  • Monitoring project schedule and scope to ensure both remain on track.
  • Initiating and implementing appropriate actions.
  • Accountable for budget across assigned project(s) including the control and minimizing of write-offs.
  • Proactively identifying out of scope activities and ensure necessary change orders are executed.
  • Proactively engaging in both quality assurance and risk management activities to ensure project deliverables are met according to both internal and client requirements.
  • Presenting at external and/or internal meetings.
  • Ensuring client satisfaction.
  • Supporting new staff in region and integrate them into the study process efficiently.

Skills and experience:

To be considered for this Project Manager Study Start-up job this ideal candidate will have the following skills and qualifications:

  • A life science or nursing degree 
  • A thorough knowledge of ICH Guidelines and GCP, the clinical trial process and a basic understanding of regulatory requirements in other countries  
  • Previous relevant clinical research experience in a pharmaceutical company/CRO, including at experience of full project management responsibility, especially in the study start up phase 
  • Working knowledge of financial control procedures (costing systems, time reporting)  
  • Experience of managing overseas clinical trials  
  • Broad knowledge of drug development process and client needs
  • Proven leadership skills with the ability to inspire and motivate staff within a field based environment  
  • Demonstrated Account Management and business development experience with a previous track record working as a Clinical Project Manager or in a Senior Clinical Study Start-up role would be advantageousJim Gleeson - Senior Recruiter at CK Clinical.

How to apply:

Apply online:

If you would like to find out more or apply for this Project Manager Study Start-up job please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk.  Please quote reference CL25848 in all correspondence.

 

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