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Clinical Scientist

Company: Integrated Resources, Inc ( IRI )
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Job Description Open to local or remote candidates Possibility of extension up to 18 months and/or conversion for the right candidate The top 3 must haves include: 1. Advanced degree (MD, PharmD or PhD) 2. Prior experience in clinical development minimum 2 years 3. Good analytical skills and the ability to review emerging data from clinical studies. Primary Role: Responsible for providing scientific support for the companys clinical research and product development initiatives under the direction of GCDL/GDTL Assist in the review of patient profiles and issue queries as needed Provides clinical scientist input into regulatory questions, run ad hoc searches Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation Assist the Medical Monitor (GCDL) in the review of trial data and development and review of clinical study documents, reports etc, Support GDTL/GCDL to provide scientific leadership in execution of clinical trials Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables Serve as a resource to address medical questions or clarify issues arising during conduct of the study Assist in the review, analysis and reporting of clinical trial data Assist with ongoing monitoring of safety data and regular medical review of clinical trial data. Serve as a scientific resource to cross-functional internal teams to facilitate quality of study execution and problem resolution Responsibilities: Collaborates with Global Development Team Lead to ensure that all development and product support activities for the assigned projects are coordinated and consistent Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams. Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities. Supports the GDTL/GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs. Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy. Participates in drug safety surveillance for Development projects. Act on behalf of GCDL/GDTL leading the interpretation of trial data and development and review of clinical study documents, reports etc, Education & Experience Requirements: Advanced degree (doctorate level) is required. Scientific/healthcare field preferred Significant experience (5 years) of clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization. Demonstrated ability to collaborate in a matrixed environment Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities a plus Experience in designing and conducting Phase II-III clinical trials; and/or Significant late-stage development research

Keywords: Integrated Resources, Inc ( IRI ), Cambridge , Clinical Scientist, Healthcare , Cambridge, Massachusetts

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