ProClinical, in support of our client, are seeking an individual to fill the role of Clinical Scientist, based in Boston, MA.
- Act as Clinical CTI referent for the study team, partners and experts.
- Design clinical studies, delivers synopsis, protocols, consent forms and amendments.
- Select and manages the various expert committees, if applicable, and manages its budget.
- Provide answers to clinical and medical questions especially for efficacy and safety.
- Ensure appropriate training of staff on indication, product, and rationale of the study and clinical aspects of the protocol.
- Interpret the results of the study and propose complementary analyses.
- Prepare communication of study results internal/external.
- Review clinical study reports.
- Participate to the development plan under project director supervision.
- Prepare the sections of product/regulatory documents within his/her reports DSUR, PSUR and investigator brochures, PIP, Orphan, Drug.
- Prepare audits or inspection by regulatory agencies within his/her perimeter.
- Provide inputs to Clinical dossier in regulatory submissions.
- Provide his/her medico-scientific expertise to associated working groups.
- Provide medico-scientific expertise to the evaluation of licensing in or -out dossiers, in collaboration with the Forecasts and Opportunities Director of the CTI.
Skills And Qualifications
- Advanced scientific qualification and relevant clinical development experience.
- Ability to work autonomously, as part of a team and in project mode.
- Strong written, verbal, and interpersonal communication skills.
- Strong analytical skills and ability to summarize.
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 Miles Tobin at (+1) 617-545-5922 or upload your resume 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.
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