Clinical Operations Manager Job – South East UK

Jim Gleeson at CK Clinical is looking for a highly experienced Clinical Operations Manager to join a large global Pharmaceutical company at their site based in Hertfordshire. This is a permanent position.

The job:

As Clinical Operations Manager you  will lead the multi functional study team, co-ordinating activities and working closely with other team members including Therapeutics, Data Management, Biostatistics, Regulatory and Pharmacovigilance.  Initially you will be Regional Lead (EU) for a complex Phase II study, but progress to Global Lead as the compound moves into Phase III.

Responsibilities will include:

  • Managing all aspects of the study from start-up to close-out, ensuring adherence to timelines and compliance with ICH GCP guidelines
  • Leadership of multi-functional study teams
  • Selection, assessment and management of CROs and other third party vendors
  • All programme management and monitoring activities
  • Budget setting and tracking

 

The ideal candidate:

To be considered for this position, you will have:

  • Extensive CRO management experience
  • Line management experience
  • A haematology background will be useful though not essential

 

How to apply:

For more information or to apply for this Clinical Operations Manager position, please contact Jim Gleeson at CK Clinical on 01438  870027or email jgleeson@ckclinical.co.uk. Please quote reference CL22703 in all correspondence.

Click here to apply online now.

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NICE Recommends MSD’s Drug for Spine Disease

The National Institute for Clinical Excellence (NICE) has recommended pharmaceutical company Merck Sharp & Dohme’s (MSD) Simponi as an option for treating ankylosing spondylitis, reports pharmatimes.com.

The drug is recommended in treating the disease, which affects the spine, in severe cases when used as directed for other tumour necrosis factor inhibitor treatments. MSD will also provide the drug at the same price for both 50mg and 100mg doses, meaning annual treatment costs are slightly over £9,000. NICE does not consider this an excessive price.

Ankylosing spondylitis has no known cause and can lead bones and joints to fuse together. Professor Carole Longson of NICE was pleased to recommend Simponi for “this progressive and irreversible condition.” MSD’s drug is more cost effective than the two current drugs used to treat the condition, so was appraised sooner than it may otherwise have been. The drug can only be taken if it is proved over a twelve week period the disease is active and conventional steroid treatment has failed.

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Statistical Programmer Job in South East

Priya Mukherjee at CK Clinical is recruiting for a Statistical Programmer to join an established Pharmaceutical organisation based in the UK.

The role

As Statistical Programmer you will support the Biostatistics team by carrying out and overseeing activities of statistical programmers and external vendors to ensure timely and accurate programming and validation activities  or clinical studies. 

Main duties includes:

  • Overseeing and managing programming activities conducted by

external vendors.

  • Supervising Programmers and their activities including assignment of projects.
  • Working with external vendors in order to develop or monitor the content and structure of SAS data sets and working closely with Project Statisticians to ensure related timelines are met for producing analysis data sets, tables, listings and graphs for clinical study reports, maintaining standards for programming activities.
  • Providing statistical programming and validation support forclinical study reports to achieve timely progress in the following areas: analysis datasets, statistical tables, figures, listings, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), electronic submissions and other internal and external requests).
  • Accessing and convertingdata to SAS from ClinTrial Database management system and PC file formats.
  • Developing and maintaining SOPs, SWPs and other relatedtechnical documents, providing input to the Database and CRF Development and providing feedback to the Data Management.
  • Providing input in developing statistical analysis plans, specifications of analysis datasets, validation plans, and other related documents and determining and researching SAS software upgrades and related system maintenance issues.
  • Pursuing individual professional development and continuing education opportunities, attending conferences and bringing in new ideas to improve the programming process.

 

 

The ideal candidate:

To be considered for this Statistical Programming job you should hold a BSc in Statistics, Computer Science, Mathematics or other related discipline, together with proven experience of working within a Pharmaceutical/CRO/Biotechnology company. You will have experience and knowledge of SAS Programming within Phases I-IV and can demonstrate significant leadership skills within this area.

How to apply:

For more information or to apply, please contact Priya at CK Clinical on 01438 743 047 or email pmukherjee@ckclinical.co.uk. Please quote reference CL22444 in all correspondence.

Click here to apply here online!

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Amgen Creates 100 New Jobs in Dublin

Amgen, one of the largest manufacturers of pharmaceutical products in the world, has announced it is opening a new factory in Dublin, reports careersportal.ie.

The building of the new manufacturing plant, to be based in Dun Laoghaire, by the pharmaceutical product developer, is to create up to 100 jobs in the area. Added to the pharmaceutical roles created by the new site, construction workers will be needed, so as many as 400 jobs will be temporarily created.

The opening of the plant comes just months after Amgen purchased Pfizer’s old site nearby. Amgen, founded thirty years ago, has quickly established itself as a major force in the global pharmaceutical business, with over 500 staff in the UK alone.

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GSK Invests in Biotech Start Up

Pharmaceutical company GlaxoSmithKline has given a press release detailing an investment in biotechnology company Autifony Therapeutics Limited.

The £1.25 million investment is to be put into the start up in return for a 25% equity stake, alongside £10 million from other investors including SV Life Sciences. £400,000 is to be put into development data for hearing loss, patent applications and several ion channel modulated compounds.

As part of the agreement, GSK will be eligible to receive another 550,000 shares upon pre-determined milestones being achieved. Upon this, further investment will be made by the consortium of other investors which will reduce GSK’s stake to 13%.

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GSK Partner’s Engima in Diagnostics

GlaxoSmithKline has struck a deal with Enigma Diagnostics to develop new diagnostic tests, reports inpharm.com.

The Enigma ML system is to be exclusively supplied and marketed across Europe and the world as part of the deal. Enigma is also to develop respiratory tests for GSK in order to quickly deliver a raw sample within a medical setting. GSK will be able to generate revenue from future tests in various therapies including infectious diseases.

Enigma chairman John McKinley believes the partnership will “deliver much needed ‘test and treat’ capability to infectious diseases management.” Eddie Gray, president of GSK’s European Pharmaceutical division, says that the joint venture is designed to “improve patient care through the provision of rapid, state of the art diagnostic tests.” Details of the transaction have not been disclosed, though GSK have made an up front payment, coupled with funding for research and bonuses for targets met.

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Clinical Imaging Associate Job – London, UK

Susan Murray at CK Clinical is currently recruiting for a Clinical Imaging Associate to join a large Pharmaceutical company based in London, UK.

The role:

Employed under an initial 12 month contract, your main responsibilities will include:

  • Conduct set-up of clinical trials within the internal imaging system under limited supervision <
  • Proactively participates in a partnership with the matrix partners
  • Ensure trials are validated before going live
  • Understand financial drivers and their role in decision making
  • Ensures that the conduct of imaging work meets GCP requirement
  • Conduct image review against basic parameters (QC)
  • Raise queries using eDC system or alternative
  • Interact with wider stakeholders, e.g. CROs/vendors (Image Transfer CROs) and monitors
  • Proactively track timelines and identify issues in order to propose strategies to implement contingencies and risk planning to meet overall study/program goals
  • Input into study plans and process documents
  • Forecast and monitor data volumes within studies and/or across programs
  • Conduct end-of-study learning debriefs for study team
  • Provide input into process improvement initiatives
  • Identify and disseminate best practices and standardization
  • Assure the quality of the deliverables
  • Facilitate effective communication and teamwork

 

How to apply

For more information or to apply for this Clinical Imaging Associate position, please contact Susan Murray at CK Clinical on 01438 743 047 or email smurray@ckclinical.co.uk. Please quote reference CL22411 in all correspondence.

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Analysts Worry About Pharma Outsourcing

Analysts are criticising CROs on the downside of the strategic relationships being put in place with big pharmaceutical companies, reports fiercebiotech.com.

Icon is cutting its 2011 financial guidance as it has to make large investments due to an outsourcing deal it has with Pfizer. Pfizer is currently outsourcing vast amounts of its research because of the cuts to their research budgets, and so companies such as Icon and Parexel are becoming the main suppliers of Pfizer’s research, something worrying analysts. Eric Caldwell noted in a story for Outsourcing Pharma that Icon will face “additional challenges ahead and we’ve taken a sharp pencil to our forward estimates.”

Icon is committed to the deal with Pfizer, however, taking on as many as 800 new staff in order to ensure there is enough manpower to do the research. Icon CEO Peter Gray believes “the major achievement of the quarter was [the] selection by Pfizer” as a clinical development partner. Gray went on to add that Icon is increasing hiring and expects to increase costs over the next two quarters as his company gears up to take on the work given by Pfizer.

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Junior Medical Writer Job – Berkshire, UK

Krishna Pankhania at CK Clinical is recruiting for a Junior Medical Writer to join an established pharmaceutical company based in Berkshire, UK.

The role:

As Junior Medical Writer, you will provide on-going support to the Publishing group and will be required to ensure that all clinical documentation for assigned projects are located and sourced from the internal archive. In addition you will have responsibility for ensuring that clinical documents published are sourced, prepared, published, reviewed and approved in a quality, timely and accurate manner.

Key responsibilities:

  • Prepare tabulated summaries along with preparation of in-text tables or narratives for the Senior Medical Writers or Medical Writer.
  • Create of hyperlinks and bookmarks for the Clinical Publisher.
  • With appropriate supervision, to undertake publishing tasks as required.
  • Carry out numeric Quality Control of documents as required under the supervision of the Lead Medical Writer.
  • Plan schedule and track all assigned oncology medical writing activities to ensure high quality, timely and accurate completion.
  • Provide regular status updates to the Lead Medical Writer for all assigned Oncology medical writing activities.
  • Under supervision write low complexity CSR.
  • Compile current study reports within the EDMS environment
  • Requesting required documents from the project manager, or other departments as appropriate
  • Checking documents for compliance with EDMS requirements
  • Entering documents into the EDMS structure
  • Interact and effectively communicate with other groups in order to source clinical documents as required by the Medical Writing Group.
  • Provide the necessary documents (protocols, clinical study reports) in Adobe PDF format
  • Scanning or converting clinical documents to Adobe Acrobat, with appropriate page formats, bookmarks and hyperlinks
  • Assessing documents for completeness and quality
  • Produce documents using other software packages as required.
  • With appropriate supervision, to undertake publishing tasks as required.
  • Perform any other activity as may reasonably be required from time to time.
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company

 

The ideal candidate:

To be considered for this position, you will have the following skills and qualifications:

  • Life Science Degree or Numerate Degree
  • An understanding of the Clinical Development process & of ICH guidelines
  • Well-developed communication, presentation, analytical and interpersonal skills

 

 

How to apply:

For more information or to apply, please contact Krishna Pankhania at CK Clinical on 01438 743 047 or email kpankhania@ckclinical.co.uk. Please quote reference CL22494 in all correspondence.

Click here to apply online now!

 

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Senior Clinical Research Associate Job – East Yorkshire, UK

Susan Murray at CK Clinical is looking for a Senior Clinical Research Associate to join a major pharmaceutical company based in East Yorkshire, UK. This is a permanent position.

The role:

As Senior Clinical Research Associate, you will be responsible for providing clinical input to designated Pharmaceutical Category Products through specification of clinical trial requirements and protocols and management of clinical trials. Further responsibilities of this role include:

  • Working in multi-functional project teams providing clinical input to deliver project requirements.
  • Representing the company in the external environment, working with CROs, KOLs, Regulators etc as required to optimise project development strategies.
  • Negotiating costs and managing payments for Clinical Trials in remit
  • Providing clinical expertise to the design of clinical trials, ensuring trial designs are appropriate to achieve the desired claims and to suggest innovative approaches to achieving the desired endpoints.
  • Ensuring that all protocols developed for pharmaceutical clinical trials address the business requirements and are fully compliant with all relevant legal and regulatory requirements and SOPs.
  • Ensuring that all clinical trials/studies are performed to the required timelines.
  • Ensuring that the relevant Clinical Affairs SOPs are implemented for all clinical trials/studies.
  • Ensuring that Investigators and Contract Research Organisations appointed to conduct clinical trials/studies are suitably qualified and experienced and to oversee the conduct of clinical trials/studies, ensuring that the required quality standards are met.
  • Reviewing, revising and writing standard operating procedures to ensure adherence to Good Clinical Practices in the conduct of Reckitt Benckiser sponsored studies.
  • Participating in meetings and conference calls with multidisciplinary study teams and vendors.
  • Liaising with quality assurance and provide input and review on data management activities.
  • Assessing potential study sites and CROs to insure that facility, staff, and patient populations meet Reckitt Benckiser’s study needs.
  • Planning and executing study start up meetings.
  • Reviewing and finalising clinical monitoring reports and report to project teams any significant issues.
  • Meeting with clinical investigators and their staff to insure that all aspects of the study are understood, and all required documentation is complete before initiating the study.
  • Managing Clinical Research Associates (in-house or contract) to monitor study progress to assure compliance with protocol requirements, applicable FDA/ICH regulations, Good Clinical Practices, and contractual agreements; review and verify monthly contractor invoices.
  • Managing Clinical Research Associates (in-house or contract) to ensure clinical supplies and test articles for appropriate storage, full drug accountability, proper destruction at the end of the study, and ensure that no product is diverted to an inappropriate use.
  • Conducting audits that include source document review, and insure timely, accurate, and complete CRF collection during the study and at study completion.
  • Ensuring adverse events are filed appropriately with Pharmacovigilance.
  • Assisting the clinical sites in preparing for possible FDA inspection.

The ideal candidate:

To be considered for this Clinical Research Associate role you will possess:

  • The ability to work effectively with minimal supervision and capability to multitask and move competently among various tasks.
  • An In-depth understanding of current Good Clinical Practices and regulations relating to clinical research.
  • Clinical development experience in a pharmaceutical development environment.
  • Strong and well developed motivational and interpersonal skills.
  • A clear and logical thinker with the ability to recognise patterns and develop innovative solutions.
  • Ability to develop and communicate argumentation in order to influence externally and internally.
  • Flexibility of thinking in order to facilitate working with many different professional disciplines.
  • Pro-active self-direction with a high level of initiative and persistence.
  • Understanding priority setting and project management.
  • Strong analytical skills with the ability to implement plans.
  • Strong communication skills, both written and oral.
  • A willingness to explore new and previously uncharted territories and an openness to change and ability to think out of the box.
  • Results oriented, entrepreneurial and self-motivating.
  • The capability to build strong working relationships to deliver outstanding results.
  • BA/BS (or advanced degree), preferably in a scientific discipline relevant to health sciences
  • A minimum of 5 years of clinical research experience, two of which must have been as a Clinical Research Associate.
  • Experience in study design, scientific methods, and field monitoring practices from drug/medical device development.
  • Certification by the Association of Clinical Research Professionals or a similar organization.
  • Experience managing CRAs and CROs.
  • This position requires travel (up to approximately 30%).

How to apply:

For more information, or to apply for this Clinical Research Associate position, 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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