Principal Statistical Programmer Job in the EU

Priya Mukherjee at CK Clinical is recruiting for a Principal Statistical Programmer to lead and support worldwide statistical programming activities for an assigned project area, for clinical trials who responsibility resides in Development.

The role:

As Principal Statistical Programmer, you will lead all statistical programming activities for multiple clinical trials or submissions. You will also set up and oversee a clinical project or trial, and provide programming support to enable delivery of high quality statistical programming work product. In addition, you will generate datasets (SDTM and ADaM) and tables, figures, listings, and documentation for clinical study reports, ad hoc requests, and regulatory submissions.

Main responsibilities:

  • Lead statistical programming activities for assigned clinical trials and submissions and support the global team of Statistical Programmers. Coordinate and provide input for assigned project and trial teams on timelines and work product required to deliver high quality statistical programming services.
  • Program, validate, maintain, and document statistical analysis programs for clinical trials on the basis of the Statistical Analysis Plan and of other trial documents following the standard company’s operating procedures and working documents.
  • Ensure that submission and trial datasets (SDTM and ADaM), tables, figures, listings, statistical output, and program documentation meet standards requirements of regulatory agencies and other departments within the organisation.
  • *Ensure that datasets, tables, figures, listings, and statistical outputs are produced in an efficient manner, following Global Statistical Programming procedures and standards. Assist with developing specification documentation for datasets (SDTM andADaM), pooled datasets, tables, figures, listings, and associated metadata.

 

The ideal candidate:

To be considered for this Principal Statistical Programmer role, you will hold a BSc in a Scientific discipline (OR Equivalent) together with proven Statistical Programming experience within the Biotechnology and/or Pharmaceutical Industry, including clinical research organizations.

You will have excellent SAS Programming skills, including  DATA step, SQL and macro development, Output Delivery System (ODS), to solve complex programming tasks, together with excellent knowledge of SDTM and ADaM programming requirements and practices, in order to develop statistical programming tools to efficiently develop study specific SDTM and ADaM data sets, statistical programming systems and standard macros for efficient programming.

You should also hold excellent knowledge of Clinical Trials Design and Analysis, including a comprehensive understanding of drug Development Phases, Clinical Trials Designs, Efficacy Endpoints and Assessments and Safety End points andAssessments.

How to apply:

For more information or to apply for this Principal Statistical Programmer role, please contact Priya Mukherjee at CK Clinical on 01438 870028 or email pmukherjee@ckclinical.co.uk.

Click here to apply online now!

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Innovative New Prostate Cancer Drug Developed

As reported by the BBC, a new treatment for the advanced and aggressive form of prostate cancer has been developed by Scientists at Queen’s University.

The drug will now be tested in a second phase, combines chemotherapy treatments with two doses of a radioactive chemical.

Speaking of the new treatment, Consultant and Senior Lecturer in Clinical Oncology, Dr O’Sullivan stated,

“This is a significant development in the fight against prostate cancer. While this combination treatment still has to go to phase two of trials, to know that this combination is safe and feasible as a treatment is a huge step forward.”

Looking for a job in the Pharmaceutical Industry? Click here to search our current jobs online now.

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Clinical Science Manager in Home Counties

Ben Traies at CK Clinical is recruiting a Clinical Science Manager to join a global pharma company based in the Home Counties.

 

The role:

As Clinical Science Manager you will provide high quality leadership, line management (including talent management and career development), coaching and functional expertise to clinical scientist and medical monitors globally.

You will ensure that clinical studies/ projects are appropriately resourced and that individuals in teams are able to maximally contribute to delivery of clinical studies/projects as well as the overall strategic aims of the department.

Further responsibilities:

  • Completing talent management and personal career development for direct reports
  • Ensuring that sufficient appropriately qualified resources are identified and made available, and ensuring that staff assignment across studies/projects as appropriate.
  • Approving all functional and project spend of their direct reports.
  • Core responsibilities
  • Provides direction and leadership to clinical science assistants/ associates and scientists if required in order to maximise their ability to provide high quality clinical science input to clinical studies/projects.
  • Provides line management including talent management, on-going performance management and personal career development for direct reports.
  • Drives change within the organisation as well as supporting, in a matrix fashion, management and staff through change.
  • Represents the function on local and global initiatives
  • Works in close collaboration with other functional managers to roll out new global processes/ initiatives, and best practices.

 

 

The ideal candidate:

To be considered for this Clinical Science Manager role you will have the following skills, experience and qualifications:

  • PhD or MD degree<p>
  • Ten years of industry experience in drug development
  • Strong leadership and motivational skills with demonstrated ability to lead and influence effectively in a matrix environment.
  • Previous people and/or project management experience including resource management and forecasting with a demonstrated ability to deliver against commitments and goals.
  • Excellent communication skills, capable of utilising a variety of influencing techniques to build respect and gain the confidence of others at all levels in the organization.
  • Displays integrity, courage and passion combined with a flexible approach to problem solving
  • Possesses broad current knowledge in the pharmaceutical industry and drug development experience with an understanding of clinical development in an international environment.
  • This is a high profile role in an industry leading company which has aggressive growth plans and a very strong pipeline.

 

How to apply:

For further information or to apply for this role please contact Ben Traies on 01438 870021 or email btraies@ckclinical.co.uk.

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Clinical Scientist Job in Home Counties

Ben Traies at CK Clinical is looking for a Clinical Scientist to join a successful pharmaceutical company based in the Home Counties.

The role:

In this wide ranging and rewarding role, you will be providing clinical science expertise to the management of studies from inception, initiation and conduct, through to their evaluation and reporting.

Responsibilities:

  • Developing clinical trial protocols and associated documents and working cross-functionally to initiate studies.
  • Advising and training your Operations colleagues and study site staff, and act as a trouble-shooter and expert on clinical and medical issues.
  • Providing science support to investigational sites and study monitors. Participating in the ongoing review and interpretation of study data, in the reporting process for serious adverse events and providing clinical input to the final reports once studies are complete.

You will use your communication skills to prepare study results for presentation to peers and for publications, poster presentations and scientific meetings. You will liaise with appropriate departments to define the timing of discussion with the FDA and other regulatory bodies, will work cross functionally on the content of submissions, and will assist in the preparation of clinical progress reports for regulatory agencies before they are reviewed by line managers.

Working in a close-knit, friendly and professional team, you will have the opportunity to oversee the day to day activities of Clinical Science Assistants/Associates, so previous line management experience would be an advantage.

In return, the company offer a competitive salary and bonus scheme plus a range of other excellent benefits you would expect from a leading organization, including 25 day’s holiday and a genuine commitment to career development and progression.

The ideal candidate:

To be successful in this role you will have a first degree in the Life Sciences and, preferably, an advanced degree (e.g. PhD) and will have experience in virological/infectious diseases, with viral hepatitis being an advantage.

In addition, you will be able to demonstrate your competence in medical research in the pharmaceutical industry or an academic environment including contributing to clinical study reports and high level of experience in review and interpretation of clinical trial data from Phase II and/or III studies. That experience should have equipped you with a strong knowledge of the whole drug development process, from start to end.

Your interpersonal and communication skills will enable you to work well with your clinical science colleagues and as part of a wider Study Management Team, where your colleagues may be located at other sites. Fluent in English, you will be able to demonstrate your written and verbal communication skills through your experience preparing documentation and presentation materials.

Working as part of a global development team and on international projects, you will be willing and able to travel.

How to apply:

If you would like to hear more about this Clinical Scientist role with a rapidly growing company please call (+44) 1438 870021 and speak to Ben Traies or email your cv to btraies@ckclinical.co.uk.

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Senior Clinical Scientist Job in Cambridgeshire

Jim Gleeson at CK Clinical is recruiting for a permanent Senior Clinical Scientist to join a leading pharmaceutical development organisation based in Cambridgeshire, UK.

The role:

As Senior Clinical Development Scientist, you will be joining the development team for a highly promising respiratory product which is currently undergoing clinical trials. You will also work closely with other functions in the business by supporting all areas of clinical development, from design through to data review.

Responsibilities:

  • Preparation of Clinical Development Plans, protocols and Clinical Study Reports
  • Maintenance of the Clinical Development Plan, with particular regard to health outcomes, epidemiology and pharmacogenetics requirements
  • Data review during the trial to ensure the highest ICH – GCP quality standards in conjunction with the project statistician, clinical operations and data management
  • In-study blinded safety review of adverse events and laboratory data
  • Being up to date with clinical and scientific developments in respiratory disease
  • Sourcing and management of third party vendors such as CROs and assay laboratories

 

The ideal candidate:

To be considered for this Senior Clinical Development Scientist position, you will have the following qualifications, skills and experience:

  • Life Science degree, preferably MSc or PhD
  • Extensive experience gained within respiratory clinical research
  • Experience of protocol design and Case Report Form maintenance
  • Very strong scientific background

 

How to apply:

For more information or to apply for this Senior Clinical Development Scientist position, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk.  Please quote reference CL22795 in all correspondence.

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QA & Training Manager Job in Home Counties

Jim Gleeson at CK Clinical is looking for a QA & Training Manager  to join a highly successful international pharmaceutical company based in the Home Counties, on a permanent basis.

The role:

As QA & Training Manager, you will responsible for setting up and managing a fully compliant training function the company. This will involve the identification of training needs and then to develop and present training sessions or identify external experts as required.

You will work closely with other global Head Offices to ensure that global policies and SOP’s match the requirements of your region.

In addition, you will plan, conduct and carry out  GCP QA audits bother internally and externally (CROs laboratories, Investigator sites) and facilitate inspections by the Regulatory Authorities.

The ideal candidate:

To be considered for this QA & Training Manager role, you will have the following skills, experience and qualifications:

  • Life Science or Nursing Degree
  • Strong experience of the drug development process, with Training and Quality Assurance experience gained within the clinical trials arena
  • Experience of working directly with the Regulatory Authorities

 

How to apply:

For more information or to apply for this QA & Training Manager job, please contact Jim Gleeson at CK Clinical on 01438 743 047 or email jgleeson@ckclinical.co.uk. Please quote reference CL21918 in all correspondence.

Click here to apply online now!

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Field-based Medical Liaison Job

Hendre Moolman at CK Clinical is  recruiting for a Medical Liaison to join an established Pharmaceutical position in this Field-based Medical Liaison role.

The job:

As Medical Liaison, your main responsibilities will include:

  • Utilise appropriate resources to stay current with the scientific literature (e.g. conducting regular literature searches and library research)
  • Attend external national and international scientific meetings
  • Meet with peer groups for formal shared learning
  • Facilitate of interactions between medical personnel and external investigators
  • Provide recommendations for investigators based on the researcher’s interests and qualifications
  • Identify opportunities for potential external research collaborations
  • Facilitate aspects of the Investigator-Initiated Trial (IIT) process
  • On a limited basis, participate in clinical trial execution, including study development, initiation and close-out activities
  • Identify key scientific developments, new research methodologies, therapy trends and/or other developments in the therapeutic area
  • Share feedback from external experts including their perspectives on data and medical/scientific concepts, views of the general therapeutic area landscape, and clinical experiences
  • Share learning from publications, external medical conferences and other appropriate channels internally
  • Conduct training on scientific/medical information content at Product Informational Speaker Training events
  • Respond to unsolicited questions in the medical information area of a medical conference exhibit booth
  • Lead/participate in Consultant Meetings
  • Develop and deliver educational presentations in accordance with applicable procedures
  • Serve as author for publications
  • Provide scientific training for sales, marketing, or other internal personnel
  • Provide recommendations to marketing for Scientific Experts and other external parties to serve as consultants, advisory board members, or speaker training faculty based on specific criteria
  • On a limited basis, conduct medical review of promotional materials

 

The ideal candidate:

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

  • Advanced degree in health sciences (PharmD, M.D., Ph.D. in a medically related field) required
  • Solid relevant clinical or therapeutic experience desired.
  • Masters or Bachelors level degree in health sciences (RN, RPh,PA, Certified Diabetes Educator, NP, etc.) considered if substantial clinical, research or industry (medical/scientific role) experience in relevant therapeutic area is present.
  • – Strong knowledge of diabetes or pain or neuroscience
  • Strong interpersonal skills, including capability to engage in professional relationship building and networking
  • Highly motivated and capable of comprehending large amounts of scientific content which is then communicated in a clear, concise fashion
  • Significant direct experience in servicing customer needs for complex information
  • Demonstrated success in self-managing priorities and multi-tasking projects
  • Ability to work effectively and share information within a team environment
  • Advanced presentation skills
  • Expertise in literature identification and evaluation
  • Familiarity with the academic community and the medical research and medical education process

 

How to apply:

For more information or to apply, please contract Hendre on 01438 743 047 or email hmoolman@ckclinical.co.uk. Please quote reference CL22757 in all correspondence.

Click here to apply online now.

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Director of Health Outcomes Job in London

Jonathan Hart-Smith at CK Clinical is looking for a Director of Health Outcomes to join his client based in London.

The job:

As Director of Health Outcomes you will play a pivotal role in guiding the organisation, providing a strategic insight and understanding of theirs client’s and stakeholders needs.

As Director of Health Outcomes you will also be responsible for developing important relationships with instrument authors and key opinion leaders and make recommendations on instrument selection and validation. You will support the Sales and Operations streams and participate in bed defences.

In addition, you will represent the company at scientific conferences, webinars and be recognized as an authority in the industry.

 

The ideal candidate:

To be considered for this Director of Health Outcomes position, you will possess comprehensive knowledge of the regulatory requirements in the EU and US for patient reported outcomes. In addition, this role demands candidates with a broad and diverse understanding of many different therapeutic areas.

How to apply:

For more information or to apply for this Health Outcomes Director role, please contact Jonathan on 01438 743 047 or email jhartsmith@ckclinical.co.uk.

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Risk Management Scientist Job in Surrey

Hendre Moolman at CK Clinical is currently recruiting for a Risk Management Scientist to join a global pharmaceutical at their site in Berkshire.

The job:

As Risk Management Scientist you will be responsible for the following:

  • review and analysis of safety data, development of routine and ad hoc safety/risk assessment reports and preparation of Risk Management Plans and Risk Evaluation and Mitigation Strategies.
  • the quality and technical content of prepared reports and making sure that they are approved by appropriate functions and meet deadlines for regulatory submission.
  • Demonstrate knowledge of relevant global regulatory requirements and practices
  • Act as subject matter expert in the development and maintenance of the Safety Quality System and training tools/programs as they relate to epidemiology
  • Provide pharmacoepidemiology support to GPS Surveillance Teams
  • Understand the roles and responsibility of the EU QPPV. Support audit readiness
  • Provide epidemiology expertise to support compounds in development, new product launches, and existing marketed products
  • Partner/collaborate with both EPM/Transition/GBD Teams and GPS TA physicians on the development of risk management plans
  • Lead / contribute to the design, execution, and assessment of specialised risk minimisation activities
  • Design, conduct, and manage pharmacoepidemiology studies
  • Work with external investigators and CROs
  • Review and develop study protocols; use population-based health statistics and electronic health information databases in evaluating safety issues
  • Provide support to EPM/Transition/GBD Teams and GPS TA physicians with patient population data from the literature or other relevant data sources to understand the nature and burden of illness of various disease/conditions for which the Company is developing new products to treat or to prevent
  • Conduct and manage epidemiology studies to characterise disease trends, frequencies, incidence/prevalence, co-morbidities, outcomes, risk factors and treatments
  • Communicate effectively with relevant internal business partners
  • Collaborate with EPM/Transition/GBD Teams and Regulatory Scientists as part of issue management teams and in preparation of responses to requests posed by regulatory authorities;
  • Support EPM/Transition/GBD Teams regarding safety information requests and other safety activities
  • Collaborate with external partners and participate on key external initiatives.
  • Develop analytic tools to support activities such as disease state characterisation, signal detection, clarification, and evaluation utilising multiple data sources
  • Partner on the development of new standardised analytic methods for selected regulatory safety documents/submissions (e.g., PSUR, ISS, product labels)
  • The role may also entail line supervisory or contract-employee responsibilities for a small group of Epidemiologists, including implementation of organisational objectives, putting in place and ensuring execution of performance management and development plans
  • The supervisory responsibilities may require up to 25-30% of the epidemiologist’s time; the remaining 70-75% will focus on direct product support and technical/scientific activities.

 

Qualifications, Skills and Experience:

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

  • A PhD or DrPH in epidemiology or other subject with high epidemiologic content.
  • Applicant must have at least 1-2 years relevant research experience in a pharmaceutical company or CRO as a pharmacoepidemiologist/epidemiologist.
  • Ability to conduct epidemiology research including preparation of study protocols and statistical analysis plans.
  • Competent in the independent analysis of data from clinical and epidemiology studies.
  • Excellent computer skills; knowledge of SAS, SPSS, Epi Info, and/or equivalent statistical software package.
  • Have strong analytic skills, oral and written communication skills, strong interpersonal and leadership skills, and be able to work independently and as a team member to resolve a variety of drug safety issues

 

Preferred Skills:

– Clinical background (e.g., PharmD, MD, RN)

– High-level knowledge of global regulations with respect to drug safety and adverse event reporting

– High-level knowledge and good understanding of GPS policies

How to apply:

For more information or to apply for this Risk Management Scientist position, please contact Hendre at CK Clinical on 01438 870 023 or email hmoolman@ckclinical.co.uk. Please quote reference CL22705 in all correspondence.

Click here to apply online now.

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