Medical Liaison Manager Job (Permanent) – East Anglia/Essex

Hendre at CK Clinical is currently recruiting for a Medical Liaison Manager to join a Pharmaceutical company based in East Anglia/Essex. You will be joining the company’s ever evolving Medical Liaison Management Team.

The role:

Within this field-based role, you ill be responding to requests from healthcare professionals for medical/scientific information that will help them to effectively treat their patients with the company products. Experience in Oncology therapy is preferred.

Reporting to the Regional Business Leader, your key responsibilities will include:

  • Responding to requests from healthcare professionals for medical/scientific information that will help them to effectively treat their patients with the company products.
  • You will manage the important liaison between the HCP and the relevant internal functions at the company, exploring and identifying opportunities for building partnerships that benefits both parties.
  • Being field based you will be providing first line medical support to the local sales team, helping them understand the medical needs of local customers, whilst adhering to the ABPI Code of Practice.
  • Naturally, you will ensure that all of your work complies with the company’s and other regulatory and industry procedures and standards, including the ABPI code of practice.

 

The ideal candidate:

The successful applicant for this Medical Liaison Manager position will have:

  • A life sciences degree and/or proven experience in a clinical or scientific role within the pharmaceutical industry or the NHS
  • A sound understanding of the NHS and ABPI Code of Practice
  • A positive and proactive approach combined with excellent communication, inter-personal and influencing skills
  • A knack for conveying complex concepts concisely combined with excellent presentation skills will enable you to translate and communicate that data.
  • Planning and management skills, combined with time management skills, allowing you to optimise and prioritise activities in order to deliver the most efficient service to your healthcare professionals.
  • The ability to proactively contribute to strategic discussions to improve the quality and relevance of the research and data generated by the company.

 

How to apply:

For more information or to apply, please contact Hendre Moolman at CK Clinical on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL22476 in all correspondence.

Click here to apply online!

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AstraZeneca AXANUM Approved Across EU

Pharmaceutical company AstraZeneca have announced that their new low dose ASA, (also known as aspirin) AXANUM, has received approval across the EU and Norway.

AXANUM is recommended for preventing heart attacks or strokes in patients who need daily low dose ASA treatment and are at risk of gastric ulcers. Those who are both at risk of cardiovascular problems and are taking aspirin are at an increased risk of stomach ulcers, with gastric or intestinal problems the main reason for stopping the usage of low dose ASA. However, by stopping treatment, the risk of cardiovascular problems is vastly increased.

AstraZeneca’s new drug is designed to stop gastric ulcers from forming, meaning continuous protection is provided against heart problems and stomach issues. The EU approved the drug and it is now subjected approval and pricing in each country. Tony Zook, of AstraZeneca’s Global Commercial Organisation wants “to bring this medicine to patients as soon as possible,” by working effectively with the health authorities.

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Sample Management & Logistics Head Job – South East

  • Permanent
  • Around £60K
  • South East

Jim Gleeson at CK Clinical is looking for a Sample Management & Logistics Head to join a leading global pharmaceutical company at their UK headquarters based in the South East.

The role:

The main purpose of this role will be to oversee a large team managing bioanalysis carried out in support of global early phase clinical trials and biomarker studies. The successful candidate will also have responsibility for development, forecasting and spend for the group and the recruitment and training of new members of staff.

The successful candidate:

The ideal applicant or this position will have Life Science degree as well as experience of managing a laboratory carrying out analysis of samples from Clinical Trials. You will also have proven line management experience and will be willing to travel internationally (typically about once a month).

How to apply:

For more information or to apply for this job, please contact Jim Gleeson on or email jgleeson@ckclinical.co.uk. Please quote reference CL22427 in all correspondence.

Click here to apply online now.

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Senior Associate Job – Study Management – Uxbridge, London, UK

Susan Murray at CK Clinical is looking for a Senior Associate to join a global pharmaceutical company based in Uxbridge, London. This is a 12 month contract position.

The role:

As Senior Associate, your main responsibilities will include:

  • Contribute to the preparation and/or review of clinical protocols, amendments, consent forms, study guides, monitoring plans, CRFs, and subject information sheets
  • Assist in the identification of/identify clinical trial investigators. Contribute to or coordinate preparation and conduct of monitors workshops and investigator meetings
  • Work with the CRSM and CRAs to develop recruitment strategies
  • Coordinate study-level investigational product arrangements, accountability and reconciliation
  • Participate in and support study teams
  • Coordinate activities associated with site start-up and management including review of site-modified informed consent forms and tracking of the budget and contract process
  • Provide input for screening and enrolment progress
  • Provide extensive clinical site/CRA support by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations)
  • Work with BSM and assay groups to coordinate shipment and analysis of clinical biological samples
  • Identify and consolidate study-related trends and report them to the clinical research manager and clinical studies team
  • Identify barriers to screening and enrolment and provide solutions
  • Support and monitor vendor activities, including relationships and training, and development of vendor specifications and scopes of work
  • Using relevant reports, identify progress of CRF data collection and query resolution. Monitor progress of studies, identify study-related trends/issues and work with the CRSM to implement corrective actions when necessary
  • Provide input to the clinical studies team for the creation of clinical study timelines and budgets
  • Assist in the processing and distribution of essential documents to the trial master file
  • Communicate regular updates to CRAs and other study staff
  • Support preparation and quality control of clinical study reports
  • Continue to increase knowledge of clinical research, clinical operations, and relevant therapeutic area

The ideal candidate:

The ideal candidate for this Senior Associate Position will have the following skills, experience and qualifications:

  • Basic Qualifications BA/BS/BSc or RN
  • Specialist experience in life sciences or medically related field
  • Previous biopharmaceutical clinical research experience (clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials, or working on clinical trials at a biotech, pharmaceutical or CRO company)
  • Ability to understand technical, scientific and medical information
  • Understanding of drug development process
  • Familiar with advanced concepts of clinical research
  • Advanced computer skills
  • Experience in interactions with outside vendors, e.g., CROs and contract labs
  • Experience with administration of site budgets and grants with supervision
  • Experience with development of prospective site-selection criteria
  • Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
  • Detailed knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements
  • Ability to write and present clearly using scientific and clinical issues terminology
  • Experience dealing with time demands, incomplete information or unexpected events
  • Good organisational and planning skills. Experience working effectively in a team/matrix environment

How to apply

For more information or to apply, please contact Susan Murray at CK Clinical on 01438 743 047 or email smurray@ckclinical.co.uk.

 

Click here to apply online now.

 

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Forest and Pierre Fabre Receive Positive Results

Forest Laboratories and Pierre Fabre Medicament have released positive phase III results for their major depressive disorder drug, reports Pharmaceutical Business Review.

The placebo controlled, random trial investigated the effectiveness of levomilnacipran in treating those who have the disorder, with the trial indicating that all dose groups improved in comparison to the placebo. The treatment is administered once daily and was well tolerated by patients.

Marco Taglietti, research and development president at the Forest Research Institute, believes the results to be “encouraging” and will help support the further treatment of those suffering from major depressive disorder.

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Clinical Trial Dropouts Increasing Rapidly

Findpharma.com has reported that clinical trial dropouts are at unsustainable levels.

Phase III trial terminations doubled from 2008-2010 compared to 2005-2007 and research and development spending was at it’s lowest for three years in 2010. The number of drugs entering Phase III trials dropped by over 50% in 2010. Phase I and II trial successes also fell by around 50% in the same year.

The increase in trial dropouts has been blamed on research and development cutbacks, with over $2 billion less spent across the whole pharmaceutical market. Reduced research and development spending is reflective of the lack of profit from pharmaceutical R&D.

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Sanofi’s Drug Faces Stumbling Block

The European Medical Association is to re-assess the risks attributed to Sanofi’s drug Multaq, reports inpharm.com.

Following reports of serious liver failure in patients taking Multaq, and the halting of the drug’s phase III trial, the EMA is looking into the drug’s risk-benefit profile. The phase III trial found that major cardiovascular events were higher amongst patients taking Multaq, rather than those using the placebo.

Multaq is expected to reach US sales of $521 million by 2016 following its approval in 2009 throughout Europe and the US for use in atrial fibrillation patients.

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Senior Manager Clinical Operations Job – Hertfordshire, UK

Ben Traies at CK Clinical is currently looking for an experienced Senior Manager Clinical Operations to permanently join a large global Pharmaceutical company based in Hertfordshire.

As Senior Manager Clinical Operations, your role will involve leading the multi functional study team, co-ordinating activities and working closely with other team members including Therapeutics, Data Management, Biostatistics, Regulatory and Pharmacovigilance.  You may also be required to lead study teams for both regional and global studies, which will involve:

  • Working closely with and act as coordinator for the cross-functional study team
  • Selection and management of CROs and Technical Service Providers (TSPs)
  • Ensuring that study is conducted in accordance with ICH/GCP guidelines, local regulatory requirements and SOPs/WPs and in accordance with agreed timelines.
  • Ensuring quality of data are acceptable and suitable for regulatory submission.
  • Involved in training internal staff and CRO staff for the study (if required)
  • May undertake co-monitoring visits with CROs when appropriate
  • Communicating effectively with upper management both orally and in writing and set and track the study progress and budget using validated clinicaltrial management tools and systems.

 

Apply now

For more information, please contact Ben Traies at CK Clinical on 01438 870021 or email btraies@ckclinical.co.uk.Please quote reference CL22322 in all correspondence.

Click here to apply online now!

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Novartis New Pharmaceutical Set For High Sales

The pharmaceutical company Novartis AG is about to see its cancer drug become a ‘blockbuster’, reports reuters.com.

Novartis’ study of the drug Afinitor combined with Pfizer’s exemestane was stopped early after positive results. Herve Hoppenot, president of Novartis’ oncology unit, has said the combined treatment will delay chemotherapy treatment in post-menopausal breast cancer sufferers.

Afinitor could well produce an income of $1.5 billion for Novartis, with the drug already approved for kidney cancer treatment and pancreatic cancer treatment in the US. Marketing approval for Afinitor’s use for breast cancer is expected to come at some point during 2012, in order to help breast cancer sufferers worldwide, some 1.38 million in 2008 alone.

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Chinese Investment to Boost British Pharma Industry

Medical Research Care Technology is in negotiations with Chinese authorities to save up to 850 pharmaceutical jobs within the UK, the Financial Times reports.

David Tapolczay, the head of MRC Technology has said that “this is probably the most significant thing to come along in research and development in the UK for 25 years”. The negotiations centre around the hiring of specialists being made redundant from Pfizer plant in Sandwich – reported on here – which will lose up to two thousand jobs.

Under the proposed agreement, a UK based clinical research team would begin testing and developing new medicines. The project is designed to keep specialists within the UK whilst also helping to expand China’s growing pharmaceutical industry.

Added to the Chinese government’s investment will be that of British private investors and a guarantee from Chinese businesses to sell the drugs developed.

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