Clinical Scientist II

Duration : 6 months contract

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Job Description :

Onsite or remote : Location strongly prefer Boston / Waltham —to enable partnership with the TA MD. If remote has to be in tied with Client Hub – Chicago (2nd preference) or South San Francisco (3rd preference).

• Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of compounds in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area
• Help develop program strategy including the clinical development plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities.
• Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR).
• Participate in scientific education of internal and external stakeholders on the pre-clinical (e.g. mechanism of action, animal models) and clinical (e.g. epidemiology, diagnosis, treatment) data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations.
• Contribute to the scientific content of Study Protocols, Investigator Brochures, Clinical Study Reports, Informed Consent Forms, briefing documents, charters, and regulatory documents.
• Contribute to creation of electronic database, IRT, and associated training documents and review data completeness and fidelity throughout study conduct.
• Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Contributes to authorship of regulatory responses and may participate in meetings.

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About US Tech Solutions :

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.