Here is an exciting pharmaceutical job one of the industry's most prestigious organisations. There is a vacancy for a Clinical Scientist to join a global top 10 pharmaceutical company at their offices located in Maidenhead, UK. The Clinical Scientist will work collaboratively with the clinical lead and team to execute the clinical program(s). Their primary deliverable is to assist in the assist in planning, executing and reporting of global clinical trials. The clinical scientist supports multiple tasks within the categories of 1) protocol and study design, strategy and training, 2) data review and interpretation, 3) study scientific integrity and oversight, 4) safety review and communication, 5) regulatory document, study report and publication preparation and review.
- Support protocol development and protocol amendments
- Create protocol training materials for site management
- Provide protocol training at the Investigator meeting
- Complete clinical sections of the Site Reference Manual
- Create informed consent form templates, and review site prepared ICFs
- Support the preparation of other clinical documents as required
- Responsible for review of subject level data across a study and for coordinating with the Lead Clinician for study level review as delegated
- Lead or participate in study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB management
- Interpret data and identify issues of moderate complexity in the data
- Independently prepares efficient plan for medical review of data
- Support the Lead Clinician to provide medical/scientific guidance during the execution of the study
- Answers specific site management protocol questions as needed
- Assist in medical issue resolution
- Responsible for the review of protocol deviation logs
- Track and reconcile SAEs across a study
- Report SAEs during Safety Review Team meetings
- Review and approval of subject narratives as delegated by the Lead Clinician
- Participate in development and review of study report
- Responsible for completion of all narrative writing activities
- Support study team in developing submissions and addressing reporting and regulatory queries (protocol level).
- Participate in inspection readiness activities
Skills and Requirements:
- BA/BS Degree in science or health-related field
- Advanced education and/or training/experience desirable.
- Demonstrated ability to support conduct of clinical trials in industry, academic, or research clinic setting
- Proven scientific writing skills, with strong inter-personal, written/verbal communication skills
- International clinical trial experience desirable
- Demonstrated effectiveness in working in a multidisciplinary, matrix team situation
- Direct therapeutic area expertise may be required in some instances.
- Understanding of scientific/clinical principles and ability to work across different therapeutic areas
- Extensive knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP
- Ability to communicate effectively and appropriately with company staff and investigator sites.
- Knowledge of the clinical development process, understand concepts of Phase II-IV and principles of study design. Experience in all phases of the clinical trial including study start, conduct and reporting.
- Ability to organize tasks, time and priorities of self and others; ability to multi-task
- Risk management and contingency planning expertise required.
- Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
- Ability to proactively communicate project issues and actions to mitigate risk and to ensure project members are aware of study status always.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.