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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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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Director of Clinical & Pharmacovigilance Job London

Jim Gleeson at CK Clinical is currently recruiting for an Associate Director of Clinical and Pharmacovigilance QA to join a global pharmaceutical company at their EU Headquarters based in London.

The role:

As Associate Director of Clinical and Pharmacovigilance QA, you will provide overall leadership for all EU QA activities within Clinical Development and Pharmacovigilance. In liaison with the global QA team your remit will be to ensure that these activities are fully compliant with ICH-GCP regulations and company policies and procedures.

Further responsibilities will include:

  • Act as the key QA representative for competent authority inspections for clinical trials and pharmacovigilance
  • Ensure that investigator, vendor, facility and system audits are carried out, that critical compliance risks are communicated to senior management and the corrective actions are implemented
  • Provide EU regional input to global quality initiatives
  • Identify and mitigate quality and compliance risks
  • Manage the EU aspects of the clinical audit and corrective action tracking database

 

 

The ideal candidate:

To be considered for this Associate Director of Clinical and Pharmacovigilance QA Job in London you will have the following skills, qualifications and experience:

  • Extensive and broad QA experience gained as either a client or vendor
  • Experience of study design, set up and conduct as well as of audits of all types
  • In depth knowledge of GxP regulations, EU regulations, FDA Good Clinical Practice and ICH guidelines
  • An understanding of Computer System Validation
  • Proven line management skills

 

How to apply:

For more information, or to apply for this Associate Director of Clinical and Pharmacovigilance QA please contact Jim Gleeson at CK Clinical on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL23220 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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