Contract Clin Research Sci (DG)
Southern, NJ - Pharmaceutical & Biotech - Remote
Date Posted: 1/3/2023 2:25:22 PM
Contract Clinical Research Scientist
REMOTE - Southern, NJ
This position may serve in a lead or co-lead role in the implementation of a clinical trial(s) within a program in alignment with the global development strategy. Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist as indicated for ongoing clinical trial-related activities to provide high-quality and timely deliverables.
Works closely with Medical Director and other Sr. level Clinical Research Scientist (as warranted). Assists to execute the clinical trial in alignment with the clinical development plan (CDP). Assists with the development of a trial protocol and to other study-related and regulatory documents. Assists in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (e.g. database lock activities). Contribute to the development of the medical data review plan (MDRP), perform ongoing data review, and summarize efficacy and safety data for interpretation/analysis. Participates in country/site selection, feasibility assessment and engage in KOL interaction. Assists in the development of charters and provide support to coordinate internal/external committee meetings including presentation preparation (i.e., Dose Escalation Committee, DMC, Steering Committee, Adjudication and Safety Committees). Assists in the development and review of study plans and serve as a liaison to project teams and CROs. Assists to prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted.
PhD, Pharm D, MS or equivalent degree preferably within the medical, biological, pharmaceutical science or related discipline. Clinical research experience preferred. Prior oncology/hematology drug development experience is a plus. Ability to work in a project oriented matrixed team environment Excellent oral, written and interpersonal (communication) skills.
Please contact Darren Gutowski at firstname.lastname@example.org