J&J’s new diabetes drug exceeds previous therapies

Reuters have reported that an experimental treatment for type 2 diabetes developed by Johnson & Johnson demonstrated greater reduction in blood sugar than older therapies.

The J&J drug, canagliflozin, also showed considerably greater weight loss than both of the other drugs and far fewer incidents of hypoglycemia, or potentially dangerous drops in blood sugar levels.  Canagliflozin, belongs to a new class of diabetes treatments called SGLT2 inhibitors that work by blocking reabsorption of glucose by the kidney and increases glucose excretion in the urine to lower blood sugar.

This information came from date collected in two 52-week studies. The date was presented on Saturday at the American Diabetes Association (ADA) meeting in Philadelphia, are part of a massive approval application J&J submitted to the U.S. Food and Drug Administration last week that comprised nine separate Phase III trials involving more than 10,000 patients

If approved it would be J&J’s first diabetes medicine.

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Global Contract Data Manager – Belgium

Priya Mukherjee at CK Clinical is recruiting for x2 Global Data Managers to work for a leading Pharmaceutical organisation in Belgium

Job role:

The purpose of this Global Data Managers role is to 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. You will be the liaison between the trial customer, the CRO(s) and other functional partners for all issues related to data for assigned trial(s). You will ensure Inspection Readiness of all data management deliverables and ensure adequate archiving of data management documentation.

Responsibilities:

As a Global Data Manager you will have the following responsibilities:

  • Liaises 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:
  • Gathers content and integration requirements for eCRF and other data collection tools
  • Establishes conventions and quality expectations for clinical data
  • Establishes expectations for dataset content and structure
  • Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones
  • Performs trial level oversight controls as described in the oversight plan, QC process and work instructions
  • Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation matrix
  • Ensures real-time inspection readiness of all IDS deliverables for the trial; Participates in Regulatory Agency and internal audits as necessary
  • Plans and tracks 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; ensures deliverables are on time and within budget.
  • Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met
  • Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate
  • Identifies and communicates lessons learned, best practices and frequently asked questions at trial level
  • Identifies and participates in process, system, and tool improvement initiatives within IDS Presents and trains at investigator and monitor meetings
  • Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate
  • Identifies and communicates lessons learned, best practices and frequently asked questions at trial level
  • Identifies and participates in process, system, and tool improvement initiatives within IDS
  • Presents and trains at investigator and monitor meetings
  • Participates in or leads non-trial/non-program projects based on specific expertise

Qualifications:

The successful candidate for these Global Data Managers jobs will be degree educated in a Life Sciences, Mathematics or Computer Sciences discipline, and have previous proven experience of working as Project Data Manager for a Pharmaceutical/CRO/Biotechnology industry.

 Priya Mukherjee - Senior Biometrics Consultant at CK Clinical

How to apply:

For more information or to apply for these Global Contract Data Manager jobs please contact Priya Mukherjee on 01438 743 047 or email pmukherjee@ckclinical.co.uk.

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Clarinex

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Novartis drug Ilaris can reduce arthritis outbreaks

Reuters reported that the Swiss drug maker Novartis released new positive data from two studies of Ilaris, which showed that patients suffering from the most severe form of childhood arthritis were less likely to experience a flare up in the disease.

Systemic juvenile idiopathic arthritis (SJIA) affects less than one child per 100,000. It causes inflammation affecting the whole body, which can involve skin rashes, fever, joint pain and swelling.

Novartis said that the results of a final-stage study showed 62% of patients with SJIA who received Ilaris became symptom-free against 32 percent of those taking a placebo. The results also showed that one third of patients could stop taking steroids within five months of using the drug.

Novartis also said it was on track to submit the drug for regulatory approval for SJIA in both Europe and the United States, based on data from this and other late-stage phase III trials presented last year.

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Contract ePRO Manager – South East

Priya Mukherjee at CK Clinical is actively seeking an ePRO Manager to work for a leading Pharmaceutical organisation in the South-East.

Responsibilities: 

This ePRO Manager position is primarily responsible for leading the development of ePRO systems to meet the needs of the study/program and internal stakeholders. The incumbent will be required to demonstrate strong project management skills.  Technical expertise in ePRO system development, user acceptance testing and provide subject matter expertise to a cross functional study team throughout the lifecycle of the system if preferable. The incumbent will lead all ePRO related activities and will be the point of contact for the supplier and study team. The incumbent is expected to maintain an awareness of industry benchmarks and evaluate innovative new technologies to ensure Global Operations Services processes are at the ‘best practice’ level of performance.

Main Responsibilities:

  • Advise/recommend to study teams the supplier and system design alternatives.
  • Provide Requests for Proposal documentation, and recommend appropriate vendors to support study needs.
  • Provide leadership and subject matter expertise for the completion of supplier set-up activities through lifecycle of the ePRO system.
  • Lead the cross functional study team through changes of scope for ePRO, providing technical expertise on the change of scope, assessment of risk, oversight of system requirements updates and user acceptance testing.
  • Lead the resolution of issues escalated by study teams as well as cross-team specific issues
  • Serve as the point of contact for inspection readiness activities between the study team and the ePRO supplier.
  • Effectively manage internal and external business partner relationships in support of Global Development Operations deliverables.
  • Monitor key performance indicators for services provided by external service providers.
  • Conduct Lessons Learned sessions following the completion of study start-up activities, and, as necessary, throughout other phases of the clinical development process.
  • Effectively support the study team in close-out/deactivation of the ePRO system.
  • Provide leadership for vendor assessment/qualification teams.
  • Continually assess new emerging technologies to optimize operational efficiencies.
  • Represent Global Operations Services as an External Partnerships expert at cross-company meetings and at external professional meetings.
  • Ensure that principles of Credo and Business Conduct Policy, Purchasing Code of Conduct, Healthcare Compliance and Ethical Code of Conduct of Pharmaceutical Medicine are used in supplier relationships.

Qualifications:

The successful applicant for this Contract ePRO Manager role will hold a Bachelor’s degree (or equivalent) in a Scientific/Mathematic or Computer Sciences discipline. They will also have:

  • Proven operational experience in clinical trials with a pharmaceutical company and/or a CRO together with demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning.
  • Experience with ePRO systems development and ePRO suppliers, together with excellent independent problem solving skill.

Priya Mukherjee – Senior Biometrics Recruiter at CK ClinicalHow to apply:

Apply online

For more information or to apply for this Contract ePRO Manager role please contact Priya Mukherjee on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24465 in all correspondence.

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Senior Regulatory Executive Job in Uxbridge UK

Shreeya Patel at CK Clinical is currently recruiting for a Senior Regulatory Executive to join a global pharmaceutical company based in Uxbridge on a permanent basis.

Senior Regulatory Executive Job Description

As Senior Regulatory Executive you will:

  • Will be involved in the preparation of high quality, chemistry, manufacturing and control (CMC) detailed regulatory documents using varied information sources.
  • Liaise closely with other personnel to ensure accuracy of such records.
  • Be working to agreed deadlines and maintaining records to reflecting project status.
  • Be responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
  • Be proactively pursuing process improvement and sharing of best practice

Qualifications, Skill and Experience:

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

  • Good written and oral communication and networking skills
  • Demonstrate the ability to focus and work with attention to detail
  • Demonstrate ability to retain critical information
  • Be aware of the contents of a marketing authorization application
  • Demonstrate team working and effective time management skills
  • Be a dynamic and highly motivated individual
  • Good at establishing strong relationships and liaising effectively with sites worldwide

How to apply:

Shreeya Patel - Pharmaceutical Regulatory Affairs Recruitment at CK Clinical

Please contact Shreeya for more details.

For more information or to apply for this Senior Pharmaceutical Regulatory Affairs position, please contact Shreeya Patel at CK Clinical on +44 (0)1438 743 047 or email spatel@ckclinical.co.uk.

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Data Programmer Analyst – South East

Mylene Paumier is recruiting for a Data Programmer Analyst to join a global pharmaceutical company at their site based in the South-East on a one year contract basis.

The job:

As a Data Programmer Analyst the main purpose of your role will be to:

  • Create and maintain a wide range of diverse, robust EDC tools for two large ongoing phase III clinical trials
  • Provide technical expertise and consultancy on a variety of different data management components, all with a common objective of delivering high quality clinical data to the study team
  • Hands on experience of the following in a programmer/developer capacity is essential: Inform Architect 4.6 (forms and rules in a ‘live’ production setting), SAS v8.2 , COGNOS Report Studio and SQL.

Qualifications and skills:

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

  • Strong ability to troubleshoot complex technical issues for ‘live’ EDC scenarios (in the platforms listed above) and propose appropriate solutions to remediate
  • Be very comfortable understanding clinical protocol designs and relating these to existing data quality tools/solutions and related test plans
  • Be comfortable translating revisions to the clinical protocol into a set of new/revised requirements and technical specifications for new or revised data quality tools, including optimised test plans
  • Ability to adapt communication style based on the audience
  • Strong time management and ability to independently prioritise own workload and negotiate with customers.

How to apply:Mylene Paumier - Recruitment Consultant at CK Clinical

For more information or to apply for this Data Programmer Analyst position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24390 in all correspondence.

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Senior Principal Programmer – Basel (Switzerland)

Mylene Paumier is recruiting for a Senior Principal Programmer to join a global pharmaceutical company at their site based in Basel on a permanent basis.

Responsibilities:

As Senior Principal Programmer, you will be responsible for:

  • The integrity of the programming/computing solutions for a major, complex global drug development program with multiple clinical indications/projects or for multiple drug development programs across CSUs within the Franchise 
  • Lead the full execution of final production output generation of quality, timely programming deliverables for CSRs, regulatory submissions/interactions, publications, and market promotions within the drug development program(s) globally 
  • In conjunction with the Biometrician/Statistical Scientist, develop the project-level programming standards and ensure compliance with project-level/disease-area/company standards. Take leadership in supporting the CSU statistician for development of disease-area programming standards, following internal guidelines   
  • Ensure that documents and specifications are consistent and comply with company standards by providing input into eCRFs and data structures, tables, listings and figures for Phase I-IV clinical trials and submission activities for the responsible drug projects/program(s)
  • Expert programming leadership for generation of analysis datasets, pooled datasets, listings, tables, figures, listings and Case Report Tabulations for Phase I-IV clinical trials and for regulatory submissions (e.g., SCS, SCE and RMP/safety update) and for other project support (e.g. publications and market promotion) according to established  milestones. Ensure development and usage of highly efficient standard MACROs within the clinical projects/program(s)     
  • In consultation with the Biometrician/Statistical Scientist, responsible for development/update of project-level programming specifications of analysis datasets and pooled datasets (e.g. in  MAP and CSPD) for the clinical drug projects/program(s) 
  • Ensure QC compliance and responsible for program records including archiving of programming and associated documentation. Responsible for quality control and audit readiness of quality programming deliverables for the drug projects/program(s)
  • Mentor/coach programmers on functional expertise and process for project support across CSUs within the Franchise; Act as a programmer expert for problem-solving in programming/computing aspects within the Franchise.  Act as a programmer expert within the Franchise for  training and/or development of new programming applications 

Qualifications and skills:

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

  • BA/BS/MS equivalent experience in mathematics, statistics, computer science, or health sciences
  • Expert knowledge of / experience with SAS and other relevant programming software 
  • Proven experience in development of advanced MACROs with high programming efficiency; strong programming and problem-solving skills   
  • Proven experience as a strong programmer lead  for clinical project(s)  and submission activities (equivalent)   
  • Good understanding of regulatory requirements relevant to statistical programming (e.g. GCP, ICH)
  • Proven ability to effectively act as a programmer representative on non-clinical initiatives; proven ability to participate in external Pharma groups on programming related matters (e.g. CDISC)   
  • Work experience in a programming role preferably supporting clinical trials/ or in the pharmaceutical industry (for MS Statistics / Computer Science graduates). 

Mylene Paumier - Biometrics Recruitment Consultant at CK Clinical

How to apply:

Apply online now:

For more information or to apply for this Senior Principal Programmer position, please contact Mylene Paumier on 01438 743047 or email mpaumier@ckclinical.co.uk. Please quote reference CL24310 in all correspondence.

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CK Clinical welcomes 2 new Recruitment Consultants!

CK Clinical Expand their Biometrics and Regulatory Affairs Recruitment Teams

Due to our great success recruiting for the Pharmaceutical and Biotechnology industries, here at CK Clinical we have expanded our Biometrics and Regulatory Affairs recruitment teams with the appointment of two new Recruitment Consultants – Mylene Paumier and Shreeya Patel.

Meet Mylene – Biometrics Recruitment at CK Clinical

Mylene Paumier - Biometrics Recruitment at CK ClinicalWe are very excited to welcome Mylene Paumier to the CK Clinical Team. Mylene has joined us as  a Recruitment Consultant and will be working along side Priya Mukherjee, specialising in Biometrics recruitment.

Mylene completed her studies in International Business in France at Rouen Business School, during which she spent one year in Japan at Ritsumeikan Asia Pacific University as exchange student. Following this, Mylene completed her Master 2 in International Business at Aston University in the UK.

During her studies, Mylene worked as a recruiter at ExxonMobil as a recruiter for almost one year and focused on recruiting in engineering and business people across France and Europe. After completing her Master 2, Mylene joined Michael Page for 6 months before joining CK Clinical.

Mylene’s big passion is travelling the world, and also enjoying going to the gym, aerobics and fitness.

Meet Shreeya Patel – Regulatory Affairs Recruitment at CK Clinical

Shreeya Patel - Pharmaceutical Regulatory Affairs Recruitment at CK ClinicalWe are also extremely excited to welcome Shreeya to the CK Clinical team. Shreeya has joined us as a Recruitment Consultant specialising in Regulatory Affairs.

Shreeya is a graduate from the University of Manchester where she studied Business Management and German (and loved every minute of it!). Following university, Shreeya worked for a high street recruitment consultancy for 8 months.

In her spare time, Shreeya enjoys socialising with her friends and travelling around the country visiting her friends from University. She also is a big fan of shopping, hitting the gym and watching television.

The team here at CK Clinical wish Mylene and Shreeya a very warm welcome to our team and wish them every success if their new recruitment roles.

Meet the CK Clinical Recruitment TeamClick here to meet the CK Clinical team >

 

 

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Senior Clinical Quality Assurance International Auditor Job in Switzerland

Jim Gleeson at CK Clinical is currently recruiting for a Senior Clinical Quality Assurance International Auditor to join one of the world’s leading pharmaceutical companies at their prestigious head quarters in Switzerland.

A number of positions are available with this pharma company covering both clinical operations and manufacturing compliance.

Senior CQA International Auditor Job Description:

As Senior CQA International Auditor, you will lead GxP audits on a global basis to ensure that all activities, whether performed in-house or via third party organisations, are fully compliant with all company, national and international regulations and legislation.

Further responsibilities will include:

  • Planning, coordinating and executing both routine and directed audits globally
  • Analysis of audit results and recommendation of corrective actions
  • Coordination and conduct of pre-inspection activities
  • Development and implementation of GxP training
  • Act as an expert GxP consultant for other functional areas

Qualifications, Skills and Experience:

  • As Senior CQA International Auditor, you will have the following qualifications, skills and experience:
  • Very extensive auditing experience within either a GCP or GMP environment
  • Excellent oral and written English communication skills
  • A second language, such as German, French, Italian or Chinese, would be advantageous
  • Auditor certification from an industry recognized body
  • Willingness to travel globally, up to 60%

 

How to apply:

 

 

 

Jim Gleeson - Clinical Quality Assurance Recruitment at CK Clinical

Please contact Jim for more details.

Please click here to apply online now.

For more information regarding this Senior CQA International Auditor, please contact Jim Gleeson at CK Clinical on +44 (0)1438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL24266 in all correspondence.

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Medical Information Associate Jobs in Surrey

Mylene Paumier at CK Clinical is recruiting for two Medical Information Associates to join a global pharmaceutical company at their site based in Surrey on a 7 months contract basis.

As Medical Information Associate the main purpose of your role will be to:

  • Provide technical and medical information with high quality customer service
  • Research and prepare responses for escalated medical inquiries as well as Scientific Response Documents related to one or two therapeutic areas

Further responsibilities of this Medical Information Associate position will include:

  • Researching and responding to inquiries received via phone, email, internet or mail
  • Document the inquiry and response accurately and completely according to relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
  • Identifying and recording, adverse events and product quality complaints as well as processing fulfilment
  • Exhibiting broad knowledge of assigned therapeutic area and a solid understanding of pertinent disease state(s)
  • Handling escalated MI inquiries from various sources
  • Creating and maintaining MI documents by ensuring that responses are medically and scientifically accurate, timely, balanced, and meet customers’ needs
  • Ensuring the alignment of response documents to global/regional/local labelling and licensing for all the Countries we support.
  • Maintains compliance with corporate and departmental training, SOPs and WIs.

As Medical Information Associate, you will have the following qualifications, skills and experience:

  • Bachelor’s degree in a science/health-related field (Pharmacy Degree Preferred)
  • Some Pharmacy/Hospital experience preferred
  • Medical Information/Pharmaceutical experience preferred
  • High level of Proficiency in both written and spoken English and one or more of the following languages: Norwegian, Danish, Finnish, Swedish, German or French
  • Proficiency with computer and software applications (Microsoft Office)

This position may required to work occasionally during bank holidays and to work hours outside of the normal local working hours.

Mylene Paumier - Medical Information Recruitment Consultant at CK Clinical

Please contact Mylene for more details.

How to apply:

Please click here to apply online now.

For more information regarding this Medical Information Associate job, please contact Mylene Paumier on 01438 743047 or email: mpaumier@ckclinical.co.uk.

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