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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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 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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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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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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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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