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Clinical Scientist in Biotech
Protocol development (first-in-human through phase 3), including writing and reviewing protocols/informed consents in conjunction with colleagues from other disciplines (e.g., Nonclinical Sciences, Translational Sciences, Clinical Pharmacology, Clinical Operations and Statistics).
Protocol implementation, including interactions with clinical teams.
Support for trial initiation and conduct (e.g., IRB responses, CRF and database reviews).
Clinical monitoring to ensure the highest standards for patient safety, trial conduct and data integrity.
Guidance for clinical data review, analysis and presentation (including writing and/or review of clinical study reports, abstracts, presentations and manuscripts)
Interaction with and support of Regulatory function to ensure timely contribution of clinical sections for the IND, IB, NDA and other communications with the FDA and other regulatory agencies.
Guidance for clinical data review, analysis and presentation (including writing and/or review of clinical study reports, abstracts, presentations and manuscripts).
Writes and reviews clinical development documents to ensure that all critical issues are addressed and resolved in an accurate and timely manner, with appropriate consultation for multidisciplinary input and advice.
Reviews all supporting trial documents for medical/clinical input including: Protocols, Statistical Analysis Plans, CRFs, Data Management Plans, Clinical Study Reports, etc.
Interacts with collaborating groups/individuals as needed to obtain the required advice or input to execute and complete clinical development documents or trial-related activities (e.g., clinical operations, pharmacovigilance, regulatory, project management, preclinical, research, CRO’s.
In collaboration with Chief Medical Officer, responsible for final analysis and interpretation of results including the development of clinical trial reports.
Researches published literature and regulatory documents to address and resolve clinical or related scientific issues in support of clinical development program.
Complies with all applicable regulatory requirements for human subject research and investigational product programs.
Complies with all applicable policies regarding health, safety and environmental policies.
RN or Clinical PharmD with at least 5-8 years of progressively responsible and relevant experience in clinical research in a biopharmaceutical organization (or equivalent).
Fluent in GCP and ICH, specifically including compliance with human subject research ethics and regulatory requirements; capable of ensuring trial compliance and implementation.
Demonstrated knowledge of and experience with the regulatory requirements for clinical trial documents and reporting, including protocol development, data collection and analysis, and preparation of key medical documents supporting regulatory submissions for FDA and EMA.
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