Astellas and DNDi work on tropical disease research

Pharma Times has reported that Astellas Pharmaceuticals has announced an agreement with the Drugs for Neglected Diseases initiative (DNDi) to collaborate on drug discovery research for three neglected tropical diseases

The 3 neglected tropical diseases are leishmaniasis, Chagas disease and sleeping sickness. These 3 together affect nearly 10 million people worldwide

Under the agreement, Astellas will provide DNDi with a selection of original compounds. These will be screened at the Swiss Tropical and Public Health Institute in Switzerland

Executive Director of DNDi, Dr Bernard Pécoul, said “We welcome Astellas as a new partner both in the field of NTDs and as part of a product development partnership. In the field of neglected diseases, and particularly for the most neglected – leishmaniasis, Chagas disease, and sleeping sickness – this new partnership reinforces the critical mass of engaged actors necessary to address urgent patient needs”

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Contract Statistical Programmer – London

Priya Mukherjee at CK Clinical is currently recruiting for a Statistical Programmer to work for a leading pharmaceutical organisation in central London.

The job:

As a Statistical Programmer you will be involved in:

  • Designing and creating analysis deliverables to meet the requirements of clinical studies.
  • Managing and enforcing standards for derived datasets and analysis outputs to maximize global data integration
  • Directing the work of external vendors providing statistical programming services to achieve quality and timely, cost-effective study deliverables.

Responsibilities:

As a Statistical Programmer you will have the following responsibilities:

  • Represent the statistical programming function in support of assigned clinical studies and projects in both the US and EU.
  • Define and manage the structure and contents of derived data set and reporting outputs following Global standards.
  • Independently develop, execute, and maintain SASÒ computer programs, including macro programs, according to Statistical Analysis Plans (SAPs), cross-study analysis and data specifications, or analysis requests to: Produce statistical analysis output (tables, listings and graphs) involving descriptive and inferential statistics to support creation of the clinical study report cross-study results for investigator brochures and regulatory submissions, and/or ad-hoc and exploratory analyses.
  • Perform data manipulations, including creation of derived data sets, related to the production of the statistical output.
  • Verify /QC study and cross-study analysis results or derived data sets produced by another statistical programmer, statistician, or an external vendor
  • Identify vendor requirements and participate in the evaluation/selection of BDM vendors.
  • Provide technical oversight of statistical programming activities to external vendors to ensure timeliness and quality of analysis data and statistical outputs.
  • Review and approve key statistical programming vendor deliverables.
  • Define and manage transfers of all externally produced analysis data and outputs.
  • Archive statistical outputs and related documentation according to company standards.
  • Anticipate and communicate resource and quality issues that may impact deliverables or timelines.
  • Propose and implement solutions
  • Escalate issues to management as appropriate
  • Contribute to increasing efficiency of the Statistical Programming function through development of programming utilities, data and output standards, and improvements to the statistical computing environment
  • Support implementation of such utilities, standards and process improvements
  • Comply with all applicable regulatory requirements and company standards and procedures.

Qualifications and skills:

The successful candidate for this Statistical Programmer role must have the following skills and qualifications:

  • MS in Statistics, Computer Science, or other related field with proven experience of SAS programming in the pharmaceutical/CRO industry.
  • Hold advanced knowledge of SAS programming language and Base SAS, SAS/GRAPH parts of SAS software, good knowledge of common procedures in SAS/STAT. Good knowledge of general programming and computing principles, experience with Windows and UNIX operating systems, and common software products and technologies used in conjunction with SAS, expertise in office software (Microsoft Office).
  • Good knowledge of clinical study documents (protocol, CRF, SAP, Clinical Study Report).
  • Working knowledge of clinical study designs, common analysis methods, descriptive and simple inferential statistics, and data presentation practices. Good knowledge of data management processes, including EDC processes, documents and data flow in clinical trials.
  • Basic knowledge of drug development process.
  • Good knowledge of FDA and ICH regulations and industry standards applicable to clinical study data and reporting on clinical trials, including data standards for electronic submissions.
  • General project management skills
  • Good oral and written communications skillsPriya Mukherjee - Senior Recruiter at CK Clinical

How to apply:

Apply online:

Fore more information or to apply for this Statistical Programmer role please contact Priya Mukherjee on pmukherjee@ckclinical.co.uk or 01438 744 047.  Please quote reference CL24539 in all correspondence.

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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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Our Latest Pharmaceutical Jobs – 11.6.2012

Looking for a job in the Pharmaceutical Industry? Please click on the links below to find out about our latest pharmaceutical jobs new in this week:

Pharmaceutical Regulatory Affairs Jobs in UK:

Regulatory Affairs Associate – Hertfordshire, UK

Pharmaceutical Industry Jobs in UK - CK ClinicalRegulatory Associate (Medical Devices) – Stevenage, UK

CMC Regulatory Executive – Uxbridge, UK

Senior Regulatory Executive – Uxbridge, UK

Regulatory Affairs Specialist – Lancashire, UK

Biometrics Jobs in UK:

Contract ePRO Manager – South East, UK

Senior Programmer – Uxbridge, UK

Senior Associate Study Management II – London, UK

Clinical Jobs in UK:

Clinical Study Facilitator – Manchester, UK

Clinical Trial Leader – West Sussex, UK

Register your CV with CK Clinical

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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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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Biostatistician – East Midlands

Priya Mukherjee at CK Clinical is currently recruiting for a Biostatistician to work for an expanding clinical trials organisation in the East Midlands.

Responsibilities:

As a Biostatistician you will assist the Director of Biostatistics with the statistical analysis and reporting of clinical trials. The main responsibilities of this role will include:

  • To perform programming, validation and production of regular statistical summaries for ongoing trials.
  • To produce ad hoc statistical summaries when requested during the course of a trial.
  • To liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
  • To extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
  • To assist in the preparation of statistical analysis plans.
  • To perform specification, programming and validation of analysis datasets.
  • To undertake the preparation of final reports, including the production of tables, listings and figures, and report writing.
  • To become familiar with developments in statistical software used in-house.
  • To assist in the maintenance of documentation e.g. the description of programs and validation.
  • To assist with Quality Assurance and Audit requirements.
  • To assist the Director of Biostatistics with all other aspects of the job as required.

Qualifications and skills:

The successful applicants for this Biostatistician role will be educated to degree level in mathematics, statistics or another subject with a strong statistical component (OR Equivalent) and should have proven experience of using statistics in a clinical research environment, including SAS programming experience. You must also possess good communication and time management skills, and work in an inquisitive manner whereby you question the validity of all outputs produced.

How to apply:Priya Mukherjee - Senior Biometrics Recruiter at CK Clinical

Apply online now:

For more information or to apply for this Biostatistician role please contact Priya Mukherjee on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL24441 in all correspondence.

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£73 million centre for translational medicine opens at Imperial College London

As reported by PharmaTimes, a major new £73 million research facility at Imperial College London for Translational and Experimental Medicine opened yesterday.

The Imperial Centre for Translational and Experimental Medicine (ICTEM) combines laboratory space for up to 450 scientists with a dedicated facility for evaluating and developing new medical treatments through clinical trials.

The six-storey building is located on Imperial’s Hammersmith Campus, alongside Hammersmith Hospital. The upper floors of the building constitute one of the largest cardiovascular research facilities in Europe, including the headquarters of the British Heart Foundation Centre of Research Excellence at Imperial.

Chancellor George Osborne who opened the facility said: “It’s an honour to open this new Imperial Centre for Translational and Experimental Medicine. It is what this country’s vision for the future of life sciences is all about. This new Centre rises to the challenge of ensuring we remain a world leader in life sciences. The future is academic research, clinical practice and industrial application coming together”

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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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