Cancer Research UK, the organisation behind the claim, believes that a “huge expansion of bureaucracy” has led the UK’s share of worldwide trials to drop from 6% to 2% in just eight years. The directive doubled the cost of manpower, effectively meaning that pharmaceutical companies are pulling out of the British pharmaceutical industry. Professor Peter Johnson, Cancer Research UK’s chief clinician, believes the directive has failed in both its attempts to make trials safer and standardise them across the EU.

The directive has led to a massive increase in the amount of regulatory work that needs to be done, meaning that there are huge cost increases. In turn, this can often mean that a drug trial is not feasible due to lack of investment. The UK’s Medicines and Healthcare products Regulatory Agency is “more rigorous than any other authority in Europe, in terms of interpreting the regulations” notes Prof. Johnson, and he adds that there has been no real “benefit in terms of quality or safety, it’s just more expensive.” However, thanks to widespread criticism of the directive, Prof. Johnson is hopeful that there will be change in the near future across the EU.

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UK pharmaceutical company SkyePharma has managed to save jobs at its research and development facility in Muttenz, Switzerland, reports pharmatimes.com.

SkyePharma’s announcement that 20% of its 100 strong workforce in Muttenz would be laid off to increase competitiveness by reducing costs was met by German pharmaceutical company Aenova making an offer to take over laboratory space and buy up extra equipment SkyePharma would not be using.

This has meant that 15 new skilled staff are to be recruited by Aenova to work in the laboratory space, including 11 technicians recruited from SkyePharma’s oral formulation and analytical development team. Aenova will also provide oral product formulation and analytical services on a sub-contract basis, SkyePharma has announced. The UK company has noted that the deal in Switzerland “has reinforced the links between the companies and could lead to collaborative development opportunities.”

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Contract Global Data Manager Job Description:

As Contract Global Data Manager, you will be:

• Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations
• The liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s)
• A member of SMT and Clinical Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (e.g., eCRF design, Database Lock).

As Contract Global Data Manager, your main responsibilities will include:

• To liaise continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners:

1.  Gathers content and integration requirements for eCRF and other data collection tools

2. Establishes conventions and quality expectations for clinical data

3. Establishes expectations for dataset content and structure

4. Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones

• Perform trial level oversight controls as described in the oversight plan, QC process and work instructions.
• Prepare or review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all deliverables for the trial; Participate in Regulatory Agency and audits as necessary.
• Plan and track content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensure deliverables are on time and within budget.
• Support the assigned clinical working group(s) to ensure deliverables are met.
• Provide input trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate.
• Identify and communicate lessons learned, best practices and frequently asked questions at trial level.
• Identify and participates in process, system, and tool improvement initiatives.
• Present and train at investigator and monitor meetings.

To be considered for this Contract Global Data Manager you will have the following skills, qualifications and experience:

• BSc in Life Sciences (OR Equivalent) with proven experience of working within the Pharmaceutical industry
• Experience of working within the Oncology therapy area together with knowledge and understanding of current industry standards (i.e. CDISC , SDTM , CDASH , etc.).
• Knowledge of technology platforms for data exchange, outstanding written and oral communication skills, negotiation skills and project Management Skills
• The ability to effectively prioritise and manage multiple tasks simultaneously.

How to apply:

Click here to apply online now.

For more information please contact Priya Mukherjee on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23467 in all correspondence.

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Senior EDC Trial Builder Job Description

The purpose of the role is to develop and program EDC trial databases for clinical trials, Phases I to IV, by setting up eCRFs and programming associated edit checks and variable mappings for data extraction based on specifications provided by the Clinical Data Coordinators. You will also program trial specific and ad-hoc reports within the EDC system; Perform thorough development testing (point-to-point) and deliver EDC trial packages and reports that are ready for User Acceptance Testing.

Further responsibilities will include:

Develop EDC trial databases for several protocols and projects. In particular:

• To develop eCRFs according to user specifications
• To program EDC edit checks according to user specifications
• To program reports within the EDC system according to user specifications
• To perform and document point-to-point developer testing
• To deliver EDC trials databases and reports that are ready for User Acceptance Testing
• To implement updates to eCRFs, edit checks, reports of ongoing trials according to user specifications
• To complete activities within the time frame of established metrics
• To adhere to SOPs and guidelines
• To identify problems, analyze them, and suggest solutions
• To support development and maintenance of Standard eCRFs, edit checks, variable mappings and reports
• To assist in authoring, and participate in the review of procedures and guidelines related to EDC programming

The ideal candidate for this Senior EDC Trial Builder position:

Priya is looking for candidates who hold a Bachelors or Master degree (or equivalent), preferably in Computer science, Life science, or Engineering. You will also have proven experience in clinical programming, set-up of clinical databasesand CRF Design, gained in pharmaceutical industry or CRO as well as the following:

• EDC builder software, preferably InForm with Central Designer or Architect, strong knowledge of database support: Oracle (SQL or PL/SQL) and equivalent clinical database management system
• Strong knowledge of CDISC/CDASH
• Strong knowledge in reporting support: Cognos, SQL, SAS or other ad-hoc query and reporting tools
• Strong understanding of clinical database management systems and/or relational databases as applied to clinical trials

Apply now:

Click here to apply online. Alternatively, please contact Priya Mukherjee on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23252 in all correspondence.

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The new facility near Basel, will be used to develop pharmaceutical formulations for new active pharmaceutical ingredients including tablets, capsules, injestable dosage forms and pre-filled syringes.

This is great news for Roche – as it will both improve their drug development process and give a welcome boost to their workforce. In fact, the pharma company have expressed their commitment to the Basel region where it currently employs around 9,000 of it’s total worldwide headcount of 80,000.

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Pharmaceutical

The approval follows the largest phase III trial conducted into pancreatic NET, which indicated that Afinator more than doubled the length of time without tumour growth to nearly a year and reduced the risk of cancer progression by around 65% compared to a placebo. Improvement was seen by all who took Afinator in the study.

Hervé Hoppenot, President of Novartis Oncology, is pleased with the EC’s decision, saying “thousands of advanced pancreatic NET patients across Europe will have a new targeted approach” for treatment. The EC’s decision applies across the EU, as well as in Norway and Iceland.

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Reuters has reported that pharmaceutical company Sanofi has been given the license to make a generic version of Pfizer’s Lipitor cholesterol treatment.

The drug, which is the best selling treatment globally, is due to lose patent protection in 2012. The French newspaper Les Echos has cited a source which says that Sanofi’s generic drug maker Zentiva has been allowed to manufacture Lipitor’s active ingredient.

The deal represents part of France’s Strategic Council of Health Industries (CSIS) programme, which gives t he original drug maker tax breaks if it allows a generic drug maker to produce a cheaper version. The programme is designed to retain jobs in the French pharmaceutical industry, and with a similar deal being struck between Eli Lilly and Delpharm, it appears to be working.

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Ridaforolimus is an oral mTOR inhibitor designed to be used for those suffering from bone sarcomas, a cancer effecting the connective tissue of the body, that were responsive to chemotherapy. Earlier this year a trial demonstrated the effectiveness of the treatment, reducing progression rates of the cancer by nearly 30% compared to a placebo. The results of the trial are sufficient to give the companies confidence in their drug, and hope that by 2015 sales could exceed $350 million worldwide.

The relatively few treatments for sarcomas means that the new therapy is greatly needed. The drug is also being tested in other forms of cancer, with mid-stage clinical trials already taking place in an attempt to combat various cancers, including breast and ovarian.

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European pharmaceutical company Boehringer Ingelheim has posted a 4% growth in the first half of 2011, reports pharmanews.eu.

Net sales reached €6.4 billion, compared to €6.2 billion in the same time period the previous year. Chairman of the Board of Managing Directors Andreas Barner is pleased that Boehringer “has further developed positively in line with… expectations.” The increase in sales has been put down to several new drugs being brought into the market, including an anticoagulant and a diabetes treatment, as well as increases in established prescription medicines.

New drugs, such as Pradaxa which is used for stroke treatment, have been approved across Europe. The medication, which is said to represent the greatest leap forward in anticoagulation therapy for fifty years, is expected to greatly benefit patients and continue to provide Boehringer with high profits. The increase in sales means a parallel increase in staff, with Boehringer adding nearly 2,000 jobs globally in the last year.

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Pharamceutical company

The site, approved in Europe and the US for tablet manufacturing, is to be leased by Aenova, which generates €250 million annually and employs 1,500 people, in order to plug gaps in its portfolio. The link with SkyePharma allows Aenova access to the US market, meaning a possible profit and job increase. Furthermore, Aenova’s French presence will be increased and complex product development will be strengthened. The move also allows expansion of the analytical development area, creating jobs.

Heiner Hoppmann, CEO of Aenova, believes “this partnership is an excellent solution” for both companies. Axel Müller, CEO of SkyePharma says that the link with Aenova “provides the opportunity to greatly increase utilisation of our Lyon facility.” As part of the agreement, Aenova will take responsibility for the 90 employees at SkyePharma’s Lyon site.

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