News

Good news for ex Kent-based Pfizer staff

Thursday, February 2nd, 2012

As reported by the BBC News, two-thirds of the staff which were made redundant due to the closure of Pfizer’s research and development site in Kent have now successfully found new pharma jobs.

The news comes exactly a year after 1,500 staff at the research and development site were told they were being redundant. Speaking of the news, Dr Annette Doherty, site leader of Pfizer Sandwich, stated that some staff had remained in the biomedical sector, some have set up new businesses themselves, a smaller percentage had returned to further education and some had moved to a different sector.

For example David Reed and Tom Martin, who were both former automation managers,  decided to set up their company Flexible Lab Solutions after they were both made redundant. Mr Reed stated, Each individual processed the announcement in a different way, some seemed quite downbeat and felt the company was out to get them while others immediately took it as a chance to do something new or go and pursue something they’d always wanted to do.”

Further news regarding the Pfizer, which is the world’s largest research-based pharmaceutical company, is that they are now negotiating with a potential buyer for the Sandwich site, which is now called the Discovery Park. Doherty confirmed that the area was beginning to attract interest from other businesses and stated, “There are a number of companies that have decided to co-locate with us and a number of small organisations beginning to form that are expressing interest in locating here at Discovery Park. With the regional growth fund and enterprise zone status here, those are the sort of incentives and support from the government that will help to incentivise businesses to set up here and be successful in the future.”

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Senior Clinical Data Associate Job in South East

Wednesday, February 1st, 2012

Priya Mukherjee at CK Clinical is recruiting for a Senior Clinical Data Associate to join a leading biopharmaceutical company based in the South East, UK. This is a contract position, initially for 6 months.

As Senior Clinical Data Associate your main responsibilities will be to:

  • Manage all aspects of Data Management on a clinical trial from set-up to close down, mainly in the area of phase IV/medical affairs.
  • Work collaboratively with Clinical Programmers, CRA, Statistical Programmers, Biostatisticians, Clinical Project Managers and Drug Safety staffs to meet project deliverables and timelines.
  • Ensures completeness, correctness and consistency of clinical data and data structure.
  • Lead the design and implementation of clinical data management process with vendors.
  • Lead the design of CRF/eCRF for sound and thorough data collection.
  • Review study protocols and assist in the planning and implementation of the data management portions of studies.
  • Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
  • Utilise reports to track study progress and ensure timeliness and quality expectations are met.

 

As Senior Clinical Data Associate, you will have the following skills, experience and qualifications:

  • Proven experience in Clinical Data Management or related Clinical Research role and a BS degree (or higher) (OR Equivalent).
  • Excellent verbal and written communication skills.
  • Excellent interpersonal skills.
  • The ability to problem solve and have people/project leadership skills.
  • Extensive knowledge web-based Electronic Data Capture (EDC) systems, Medidata RAVE experience preferred.
  • Knowledge of Clinical Data Management systems and industry wide thesauri, such as MedDRA together with an understanding of Medical Affairs.
  • Work with minimal supervision.

 

How to apply:

Click here to apply online now.

For more information, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23612 in all correspondence.

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Contract Senior Data Manager Job in UK

Tuesday, January 31st, 2012

Priya Mukherjee is recruiting for a Contract Senior Data Manager to join a leading biopharmaceutical organisation based in the UK.

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

  • Training and mentoring of Data Managers on processes, projects and programmes
  • Leading or participating in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
  • Contributing to the continuous improvement of CDM and the wider Development organization through information sharing, training and education
  • Promoting and being an advocate of CDM internally and externally
  • Representing CDM at cross functional project team meetings
  • Project level coordination of and day to day oversight of CDM tasks including:
  • The co-ordination of lead DM’s within the project
  • Reviewing of all CDM documents within a project area to ensure a consistent approach
  • Overview of project timelines and metrics to ensure databases are delivered to set timelines
  • Approving database locks and unlocks
  • Ensuring that quality control checks are occurring such that quality databases are delivered
  • Developing and co-ordinating project level training for data management staff
  • Reviewing and approving study specific training
  • Managing vendor deliverables and relationship at the project level
  • Reviewing of all study level non CDM documents for awareness and project level consistency
  • Ensuring project plans are developed for key activities.

 

As Senior Data Manager you will have the following qualifications, skills and experience:

  • Qualified to BSc Level in a Scientific discipline (OR Equivalent)
  • Proven experience of working as a Project Data Manager within the Pharmaceutical industry
  • Strong EDC experience, preferably Medidata RAVE, together with Oncology experience
  • Experience of working in cross functional teams as well as oversight of remote staff

 

How to apply:

Click here to apply online now.

For more information, please contact Priya Mukherjee on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk.

Please quote reference CL23614 in all correspondence.

Click here to search our Data Management jobs now.

Senior Statistical Programmer Job in South East, UK

Tuesday, January 31st, 2012

Priya Mukherjee at CK Clinical is recruiting for a Senior Statistical Programmer to join a leading Pharmaceutical company based in the South East.

Senior Statistical Programmer Job Description:

As Senior Statistical Programmer you will provide programming expertise for clinical trials and support the computing environment within Clinical Biometrics. The main responsibilities of his Senior Statistical Programming role will include:

  • Review the database set-up in terms of format and content of SAS data sets provided by data management for suitability for statistical reporting, in conjunction with the study statistician
  • Review and input to Data Validation Plans written by the data manager, in conjunction with the study statistician and relevant clinical personnel.
  • Generate the List of Tables, Figures and Listings in conjunction with the study statistician and input from relevant clinical personnel.
  • Write programs to generate analysis data sets, data listings, tables, other summaries and graphics in accordance with company standards and regulatory requirements
  • Produce the above computer output, in agreement with the study statistician and relevant clinical personnel, suitable for inclusion in the Clinical Study Report or other relevant documents.
  • Perform Clinical Biometrics paper and electronic archiving of datasets, programs and related files from completed studies
  • Be conversant with SAS and its uses, assist in solving problems with SAS for members of Clinical Biometrics. Keep Clinical Biometrics up-to-date with developments in SAS software.
  • Be aware of and make optimal use of the computer systems used by Clinical Biometrics, including validation of such systems.
  • Perform Quality Control of summary statistics output, graphics and listings.
  • Mentor junior statistical programmers in terms of assisting in their knowledge of SAS and the Clinical Biometrics computing environment.

 

As Senior Statistical Programmer you ill have the following skills, experience and qualifications:

  • A Graduate qualification in Mathematics/Statistics/Computer Science/Life Sciences
  • A sound understanding of the practical use of SAS programming and the computing environment relevant to statistical programming gained through proven employment experience preferably in the pharmaceutical industry or CRO.
  • Numerate, and be able to program calculations and hold knowledge of application of summary statistics.
  • Good attention to detail, be well organised, self motivated and have good communication skills.

 

How to apply:

Click here to apply online.

For more information or to apply for this Senior Statistical Programming position, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23608 in all correspondence.

Click here to search our current Statistical Programming jobs.

Director of Biostatistics Job in the Midlands

Monday, January 30th, 2012

Priya Mukherjee is recruiting for a Director of Biostatistics to join a leading company based in the Midlands.

Director of Biostatistics Job Description:

As Director of Biostatistics, you will lead the Biostatistics Department in providing statistical services for clinical trials. Your responsibilities will include:

  • To provide leadership of the Biostatistics Department, co-ordinating and assisting staff in their duties.
  • To be responsible for staff allocation within the department, to ensure sufficient expertise and to delegate responsibility appropriately.
  • To identify the departmental training requirements and to provide training as required. 
  • To perform staff reviews.
  • To represent the Biostatistics department at internal meetings and to liaise with in-house project managers and fellow departmental heads.
  • To provide statistical advice/consultation and/or any related services required by Sponsors.
  • To lead projects on behalf of the Company.
  • To represent the Company and participate at meetings and conferences.
  • To be responsible for statistical software administration for the Company.
  • Additionally, the job holder is expected to perform all duties associated with the post of Senior Statistician.
  • Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 

As Director of Biostatistics, you will have the following skills, experience and qualifications:

  • Experienced in working closely with Sponsors, and have good communication skills in order to provide clear statistical advice.
  • Experience co-ordinating the workloads of other staff and possess good time-management skills.
  • A thorough knowledge of statistics.
  • Computer literate with a willingness to adapt to various computer systems; a detailed knowledge of SAS, and other related software is essential.

Interested applicants will be educated to degree level in mathematics, statistics or another subject with a strong statistical component (OR Equivalent) and have proven experience using statistics in a clinical research environment, including SAS programming. You should also be able to demonstrate a high level of competency, responsibility, and the ability to work independently.

How to apply:

Click here to apply online now.

For more information, please contact Priya Mukherjee at CK Clinical on +44(0)1438 870028 or email pmukherjee@ckclinical.co.uk. Please quote reference CL23605 in all correspondence.

Search our Biostatistics jobs now.

Pharmacovigilance Specialist Job in Cambridgeshire

Friday, January 27th, 2012

Hendre Moolman at CK Clinical is currently recruiting for a Pharmacovigilance Specialist to join a successful pharmaceutical company based in Cambridgeshire.

 

Pharmacovigilance Specialist Job Description

As Pharmacovigilance Specialist, you will be responsible for the overall coordination of serious adverse event (SAE) processes and database activities and the PVG coordination of sponsor and investigator meetings. You must maintain knowledge and understanding of SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues. In addition, you  will help prepare for and attend audits, kick-off and investigator meetings. The Senior Safety Specialist will act as mentor to new staff.

Further responsibilities of this Pharmacovigilance Specialist position include:

  • Set up and maintain accurate data within the SAE tracker for all assigned projects.
  • Set up and QC of data entry into safety database.
  • Prepare and submit client SAE notifications.
  • Review SAE reports for completeness, clinical consistency and agreement with source documents.
  • Identify and send SAE queries to investigator sites either directly or through CRAs.
  • Prepare Physician Assessment Form and ensure that medical monitor assessments of SAE documents are completed and distributed according to project requirements.
  • Coordinate SAE activities for assigned projects, including study start-up, maintenance and close-out activities, SAE reconciliation, budget tracking and forecasting for assigned studies.
  • Produce and maintain accurate status and metric reports for assigned projects.
  • Prepare and QC patient SAE narratives.
  • Produce accurate SAE data for reporting purposes (including regulatory reporting).
  • Prepare and submit expedited safety reports and manage the reporting process.
  • Identify project resourcing needs.
  • Promptly advise the Manager/Associate Director/Director, Pharmacovigilance of any significant safety and regulatory concerns.
  • Develop and maintain a cooperative working relationship with project team members.
  • Attend and professionally represent PVG at team meetings, client meetings, and other appropriate meetings, as required, for assigned projects.
  • QC safety-related paper documents/electronic data/database entries prepared by others.
  • SAE reconciliation – Review Data Management listings, database reports, and validation checks
  • Adhere to corporate policies, SOPs, WPDs, other guidance documents, sponsor SOPs/directives and project specific WPDs.
  • Adhere to current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents, and safety issues.
  • Participate in internal training initiatives to keep up-to-date in safety regulations, processes, and company policy regarding Safety issues etc.
  • Review regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
  • Prepare and give presentations to client and/or project teams.
  • Coordinate sponsor, investigator and Data Monitoring Committee (DMC) meetings.
  • Perform internal audit activities for departmental processes and procedures.
  • Assist with external audit activities.
  • Provide input to SOP/WPD generation and revisions.
  • Exercise independent judgement to manage and resolve safety issues for standard non-complex projects, including PVG coordination of sponsor and investigator meetings, with minimal supervision.
  • Develop supervisory and mentoring skills for standard SAE processing, study set-up, maintenance, close-out and narrative generation.
  • Oversee and give direction to a project group/team.

 

As Pharmacovigilance Specialist, you will have the following qualifications and experience:

  • Bachelor’s degree in Life Sciences or Nursing
  • Proven medical/clinical experience or clinical/safety experience and SAE processing experience/or clinical safety experience
  • In some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications

 

How to apply:

For more information or to apply for this Pharmacovigilance Specialist position, please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL22783 in all correspondence.

Click here to search our current Pharmacovigilance jobs online now.

Meet Hendre – Specialist in Drug Safety and Medical Affairs Recruitment

Wednesday, January 25th, 2012

Hendre is a specialist in Drug Safety and Medical Affairs recruitment. The types of positions he recruits for include:

  • Drug Safety Associates
  • Drug Safety Officers
  • Senior Drug Safety Officers
  • Principle Drug Safety Officers
  • Drug Safety Managers
  • Pharmacovigilance Associates
  • Pharmacovigilance Officers
  • Senior Pharmacovigilance Officers
  • Principle Pharmacovigilance Officers
  • Pharmacovigilance Managers
  • Medical Affairs Assistants
  • Medical Affairs Officers
  • Medical Affairs Officers
  • Senior Medical Affairs Officers
  • Medical Affairs Managers
  • Medical Liaisons
  • Scientific Liaison
  • Medical Liaison Managers
  • Scientific Liaison Managers
  • Medical Science Liaisons
  • Medical Development Advisors
  • Scientific Advisors
  • Scientific Advisers
  • Therapy Area Advisors
  • Therapy Area Advisers

To contact Hendre, please call +44 (0)1438 743 047 or email hmoolman@ckclinical.co.uk. You can also register a vacancy with us below:

Register a vacancy

Your Name (required)

Company

Your Email (required)

Telephone Number

Job Title of Vacancy

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Senior Medical Affairs Officer Job in West Sussex

Wednesday, January 25th, 2012

Hendre Moolman at CK Clinical is recruiting for a Senior Medical Affairs Officer to join a leading pharmaceutical company in West Sussex.

Senior Medical Affairs Job Description:

As Senior Medical Affairs Officer you will be responsible for the provisions of a medical information service to internal customers and to external contacts. You will also provide support to the sales, marketing and regulatory teams in the UK by providing medical evaluation and information in all activities to ensure targets are met to ensure compliance.

Further responsibilities of this Senior Medical Affairs position include to:

  • To be accountable for the effective management and continuous development of UK Medical Information service.
  • Represent the UK in global Medical Affairs network (OTC).
  • Develop and maintain medical and scientific awareness of the Consumer Health product portfolio and disseminate information to internal customers.
  • Provide medical advice to support sales, marketing, and other internal departments including medical input to claims development and creative approvals and expert input to data and literature evaluation, making clear to the business the impact of any findings.
  • Ensure compliance with the relevant Codes of Practice in relation to promotional materials.
  • Act as internal and/or authorised ABPI signatory for promotional materials as appropriate.
  • Provide medical input into local PR, including review and adaptation of global PR to local needs/regulations, under the internal quality control procedures.
  • Support marketing in development of customer focused claims as well as monitoring/challenging claims made by competitors.
  • Support the local Sales and Marketing teams, producing high quality briefing and training materials and development of brands promotional and communication material.
  • Produce, update and approve prescribing information in a timely fashion and in line with relevant regulations.
  • Co-ordinate and implement timely updating of product entries in external databases, compendia and journals.
  • Act as company administrator for eMC and NHS prescription systems.
  • Advise on medical issues relating to advertising copy, patient information leaflets, summary of product characteristics, etc.
  • Process Drug Safety cases and perform follow up activities as required.
  • Be a member of the UK signal detection team.
  • Scientific evaluation of new claims and line extension possibilities presented by Global Drug Regulatory Affairs or Marketing on existing portfolio.
  • Scientific evaluation on feasibility of New Project Development presented by Global Drug Regulatory Affairs or Marketing.
  • Interface with the medical and healthcare community.
  • Develop and maintain contacts with Specialists in appropriate fields and Trade Associations to further the interests of NCH.
  • Sales force training and support across UK and ROI region.
  • Assist with the training of colleagues in the medical aspects of our business.
  • Provide company wide training in the applicable Code(s) of Practice.

 

As Senior Medical Affairs Officer you will have the following qualifications, skills and experience:

  • BSc in relevant subject or pharmacist
  • Proficiency in analysing scientific data and drawing the relevant conclusions
  • Proficiency in communication skills, how to explain complicated matters in a simple way

How to apply:

Click here to apply online.

For more information, please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL23455 in all correspondence.

Click here to search our other Medical Affairs jobs now. 

Bayer Healthcare gives $5m to biopharmaceutical company Trius

Tuesday, January 24th, 2012

As reported by the Pharmaceutical Business Review, biopharmaceutical company, Trius Therapeutics has received $5m payment from Bayer Healthcare.

The payment came after a successful late-stage trial of an experimental skin infection treatment called Tedizolid. It was found that the drug was as effective in treating infections such as MRSA which are slowly become resistant to antibiotics.

Trius will begin their second late-stage trial in September with results expected in early 2013. These results will be used to help their applications for drug approval with the Food and Drug Administration and the European Medicines Agency.

Click here to search our pharmaceutical jobs now.

Senior Scientific Advisor Job in Middlesex

Tuesday, January 24th, 2012

Hendre Moolman at CK Clinical is currently recruiting for a Senior Scientific Advisor to join a leading pharmaceutical company based in Middlesex on a contract basis.

Senior Scientific Advisor Job Description

As Senior Scientific Advisor you will have a key role in the planning and development of promotional and education campaigns and materials. Further responsibilities will include:

  • Key role in the planning and development of promotional and educational campaigns and materials, with responsibility for
  • Briefing and provision of data to external agencies
  • Editing, evaluating and approving the materials produced by agencies
  • Scientific content (core claims) ensuring the data maximise commercial potential.
  • Medical accuracy and compliance with the product licence and the relevant Codes of Practice
  • Provide analyses and review of products, therapy areas and competitor products, making recommendations, which assist marketing in the determination of current and future strategic direction.
  • Develop therapy area reviews, product monographs, slide sets, training packages etc. as appropriate to business and customer needs.
  • Input into the defence of complaints made by competitor companies, medical professionals or regulatory authorities against promotional statements or activities.
  • Prepare portfolios of data and input into product submissions for influential bodies such as the National Prescribing Centre, National Institute of Clinical Excellence (NICE), Scottish Medicines Consortium and National Tenders.
  • Ensure the medical information department is up-to-date on new products/campaigns and commercial issues by leading training and factsheet management and by giving advice on complex issues.
  • Prepare and deliver presentations for sales force training programmes and other materials and briefing sessions, ensuring scientific data and medical concepts are understood and consistent with promotional strategy.
  • Responsible for sending briefing information out to sales force, keeping them up to date with important clinical information on our own and competitor products
  • May play a key role in preparing tailored responses to support market access issues for a defined product in particular geographical areas/PCTs/hospital trusts etc.
  • Involvement in the Key Evidence Generation (KEG) process to identify data needs and options for generating evidence, including in the planning of clinical trials ensuring that they are aligned to short- and long-term business needs. Help to identify opportunities for the interpretation of trial results for commercial benefit.
  • Develop networks across the UK Company as a whole.
  • Required to input into the longer-term strategy for a disease area e.g. as a member of a disease strategy team.
  • May be required to lead cross-functional teams/projects, including those aligned to key commercial processes.
  • May be required to mentor for other Scientific Advisors.

 

As Senior Scientific Advisor, you will have the following qualifications, skills and experience:

  • Science Degree/Professional Qualification
  • Wide breadth of experience of product at different stages of the lifecycle
  • Ability to assimilate, interpret and disseminate scientific data and information company products and their competitors, and to communicate appropriate information to enhance current strategic and promotional activities
  • Ability to facilitate internal relationships within both the UK Company, and the company as a whole
  • Ability to gain the credibility of senior managers and external opinion leaders/influencers.
  • Ability to prioritise and organise workload, and think clearly under pressure and time constraints
  • Knowledgeable of the legal and ethical issues and codes affecting the promotion of new and existing products and apply these appropriately.
  • Ability to lead, motivate, influence and negotiate cross-functional teams
  • Proactive, self motivated, self-reliant
  • Copy approval and compliance experience is a requirement for this contract.

 

How to apply:

Click here to apply online now.

For more information, please contact Hendre Moolman on 01438 870 023 or email hmoolman@ckclinical.co.uk.

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