Clinical Science Director – London

Jim Gleeson is recruiting for a Clinical Science Director to join an expanding pharmaceutical company to be based at their London offices on a full time, permanent basis.

Responsibilities for this role include developing and monitoring a project strategy and clinical development plan in line with corporate objectives. This will involve working closely with colleagues in translational medicine, regulatory affairs, CMC manufacturing, drug safety, pharmacokinetics etc as well as with external consultants, key opinion leaders and contract research organisations.

Our client is a successful international company who require a Clinical Science Director with extensive oncology research experience who has excellent leadership skills.

Click here for more information and to apply

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Clinical Data Analyst – London

Priya Mukherjee at CK Clinical is currently recruiting for a Clinical Data Analyst to work for a leading pharmaceutical company in the London area.

Responsibilities:

As Clinical Data Analyst, you will have the following responsibilities:

  • Resolving mappings issues picked up through the automated QC reports
  • Reviewing DRAFT mappings developed by others
  • Consulting with the company’s SDTM Committee on mapping related issues
  • Conducting QC of the SDTM datasets to ensure mappings have been implemented correctly
  • Drafting SDTM mappings for NEW core standards
  • Supporting programmers with mapping issues
  • Supporting study teams with outsourced studies

Qualifications, Skills and Experience:

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

  • Proven experience of working in Clinical Data Management within the pharmaceutical industry
  • CDISC knowledge in particular SDTM
  • Knowledge and experience of mapping to SDTM standards and knowledge of clinical trial data.

 

Priya Mukherjee - Clinical Data Management Recruitment

Please contact Priya for more details.

How to apply

Click here to apply online now >

For more information regarding this Clinical Data Analyst role, please contact Priya Mukherjee at CK Clinical on +44 (0)207 470 5670 or email pmukherjee@ckclinical.co.uk. Please quote reference CL25704 in all correspondence.

 

 

 

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Senior Quality Assurance Auditor – London

Jim Gleeson at CK Clinical is recruiting for a Senior Quality Assurance Auditor to join a leading healthcare charity at their site in London

Responsibilities:

As a Senior Quality Assurance Auditor you will be supporting a busy drug development team within a leading healthcare charity where you will plan, execute and report on Phase I and II clinical trials. These audits will be both internal and external and include Investigator Sites, laboratories, documentation, TMFs and databases. Activities will include assisting in staff training, representing the organisation at conferences and the review and update of SOPS.

Qualifications:

To be considered for this Senior Quality Assurance Auditor role you must have the following qualifications and skills:

  • BSc or Nursing qualification
  • QA auditing experience gained within clinical trials
  • An excellent understanding of ICH GCP
  • A good knowledge of the EU clinical trials regulatory documents that affect UK clinical trials
  • Excellent interpersonal skills and able to work in a highly collaborative fashionJim Gleeson -  Senior Recruiter at CK Clinical

How to apply:

Apply online:

For more information please contact Jim Gleeson on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL24650 in all correspondence

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Biogen and Isis Team Together in Rare Disease Pact

PharmaTimes reported that Biogen Idec and Isis Pharmaceuticals are forming a partnership to develop an antisense drug for muscular dystrophy in adults (DM1)

Muscular Dystrophy is estimated to affect 150,000 patients in the USA, Europe and Japan and is passed from parent to child with each subsequent generation experiencing more severe disease earlier in life.

Isis will be responsible for the discovery of a lead antisense drug candidate targeting DMPK for the treatment of DM1 (muscular dystrophy in adults)

Steven Holtzman, head of corporate development at Biogen said that “the unmet need is great and there are currently no therapies to slow or stop progression of the disease” He also said DM1 has “an identifiable genetic cause, the program fits with our mission to bring innovative therapies to patients with serious neurologic diseases, and Isis’ antisense compound has the potential to make a real difference”

 

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Senior Clinical Study Manager Job in London, UK

Russell Oakley at CK Clinical is currently recruiting for a Senior Clinical Study Manager to join a global pharmaceutical manufacturer based in London, UK on a permanent basis.

The company:

This client is a global pharmaceutical manufacturer involved in the development of pharmaceuticals in the therapeutic areas of oncology, diabetes, cardiovascular and hypertension.

Senior Clinical Study Manager Job Description:

As Senior Clinical Study Manager, you will be responsible for  the execution of Phase II and Phase III oncology studies according to ICH guidelines in support of the clinical strategies defined in the Integrated Development Plan (IDP) as they relate to European specific responsibilities. Support of Phase I trials may also be required.

You will be a key member of the oncology clinical team responsible for conducting clinical studies, which includes participating in writing of study protocols; total management of assigned study conduct, including oversight of the study team and CROs/other vendors; identifying and resolving study site issues; managing the study budget and study closeout with a focus on European activities

As Senior Clinical Study Manager, you may also be required to participate in the training of more junior members of staff.

The role will be based in central London but will involve international travel as well as work centred in the UK.

Qualifications, Skills and Experience:

The ideal candidate for this Senior Clinical Study Manager, you will have the following qualifications, skills and experience:

  • Bachelors Degree preferably in Life Sciences, or R.N., or international equivalent.
  • Demonstrable clinical trial management experience including accumulation of one year of monitoring experience required.
  • Demonstrated ability to manage multiple clinical trials on time and within budget.
  • Superior communication skills: written, oral, interpersonal and presentation.
  • Excellent problem solving and analytical skills.
  • Must work effectively in a cross-cultural matrix team environment and be flexible to contribute to the needs of the group.
  • Clear, direct, tactful communication skills are required.
  • Good writing skills with experience in writing study protocols, summaries, clinical brochures, FDA annual reports and other clinical documents for submission to the FDA. Writing should be clear, concise and accurately represent findings.
  • Strategic thinking – Begin to participate in strategic planning. Able to anticipate potential problems and obstacles and plan accordingly.
  • Ability to organize and manage a CRO and multiple sites participating in a clinical trial.
  • Ability to prioritize work effectively to meet timelines.
  • Demonstrates professional and effective presentation skills.
  • Analytical skills – ability to identify study-related, CRO-related or site-related issues, determines the causes and possible solutions to the problem.
  • Responsible for resolving issues with study conduct with appropriate staff, CRO and study sites for a clinical study.
  • Solid judgment is required before applying the solutions program wide.
  • Good judgment, professionalism and independence are needed in interfacing with staff, CROs, study coordinators, and investigators Interpersonal Flexibility – ability to adapt to other personalities and cultural differences, in a respectful manner that is conducive to goal achievement
  • Resource Management – ability to manage internal and external vendor resources related to study trial conduct.

The following skills are not essential but would be desirable for this Senior Clinical Study Manager position:

  • In depth knowledge of oncology clinical trials.
  • Familiarity with MS Outlook, Word, Excel, etc.
  • Participation in NDA/CTD process

How to apply:

Russell Oakley - Senior Consultant at CK Clinical
Please contact Russell for more details.

Click here to apply online now.

For more information regarding this Senior Clinical Study Manager job in London, please contact Russell Oakley at CK Clinical on +44 (0) 114 283 9956 or email roakley@ckscience.co.uk. Please quote reference CL24219 in all correspondence.

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Clinical Compliance Manager Job in London

Jim Gleeson at CK Clinical is currently recruiting for a Clinical Compliance Manager to join a global pharmaceutical company based in London.

As Clinical Compliance Manager you will:

  • Drive process improvement within clinical operations and lead the development of GCP quality management documentation.
  • Work in an international role and will be working cross-functionally and with many sites.
  • Deliver staff training on clinical trial procedures, SOPs and ICH-GCP
  • Contribute to quality document integration across the organisation.

As Clinical Compliance Manager you will have:

  • Proven experience with GCP quality management systems
  • Strong project management experience
  • Excellent written and verbal communication skills

How to apply:

Click here to apply online now.

For more information regarding this Clinical Compliance Manager job, please contact Jim Gleeson on  01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23989 in all correspondence.

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Senior Clinical Compliance Specialist Job in London

Jim Gleeson at CK Clinical is recruiting for a Senior Clinical Compliance Specialist to join an international pharmaceutical company at their site based in London. This is a one year contract position.

As Senior Clinical Compliance Specialist you will ensure that European clinical trial activities are fully compliant with all internal and external regulations. This will cover the company’s own work and that of external vendors, managing technically complex audits and defining and communicating compliance risks.

 

As Senior Clinical Compliance Specialist you will have the following qualifications skills and experience:

  • Very extensive Clinical Quality Assurance experience, including hosting regulatory authority inspections
  • In depth knowledge of GxP regulation, ICH guidelines and FDA GCP requirements
  • Excellent understanding of the clinical trial and auditing processes
  • Ability to travel internationally, up to 40%

How to apply:

Click here to apply online now.

To find out more, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23127 in all correspondence.

 

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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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