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    Clinical Scientist - Cambridge, United States - The Fountain Group LLC

    The Fountain Group LLC
    The Fountain Group LLC Cambridge, United States

    3 weeks ago

    The Fountain Group LLC background
    Description
    The Fountain Group are a national staffing firm and are currently seeking a Clinical Scientist for a prominent Pharmaceutical client of ours. This position is Remote. Details for the position are as follows:

    Job Description:
    • Pay: /hr.
    • 12 month assignment to start with potential for extension or conversion.
    • Fully Remote position. Candidate must be able to work EST hours M-F 8AM- 5PM.
    • Must have: Ophthalmology/retina experience is required. A minimum of 3 years of clinical research and clinical drug development experience within the ophthalmology/retina pharmaceutical industry or CRO is required.
    • Knowledge in ICH - GCP (Good Clinical Practices) (International Conference on Harmonization).
    • Nice to Have: Statistical, data management, and regulatory knowledge.
    • Assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager responsibilities e.g.: managing or contributing to the operational activities from clinical trial set-up to clinical study report in compliance with quality and regulatory processes.
    • Responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program.
    • This individual will provide active scientific contribution to a cross-functional clinical team developing a molecular entity, provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials, and take responsibility for coordinating completion of clinical study reports and support preparation of relevant documents for regulatory filings.
    • Under the guidance of the individual's manager in the Therapeutic Area department, the individual collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed.
    • The individual ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
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