Clinical Scientist job in Maidenhead, Berkshire

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The Clinical Scientist will work collaboratively with the clinical lead and team to execute the clinical programmes. Their primary deliverable is to assist in the assist in planning, executing and reporting of global clinical trials.

Job Responsibilities:

The clinical scientist support multiple tasks within the categories of:

1) Protocol and study design, strategy and training

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

2) Data review and interpretation

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 an efficient plan for medical review of data

3) Study scientific integrity and oversight

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

4) Safety review and communication

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

5) Regulatory document, study report and publication preparation and review.

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

Role 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 interpersonal, 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.
The ideal candidate would have a nursing or some form of medical background

To Apply:

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 Amy Quinn on +44 207 4400 633 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.