Clinical Research Scientist

6 days ago

Apply Now

Receive Emails with Similar Jobs

Genmab

WebsiteLinkedInAll Job Openings

1001 - 5000

💰 $134M Post-IPO Equity on 2010-06

Description

• Lead or co-lead a less-complex clinical trial(s) within a program. • Works in collaboration with a Medical Director and Sr. level Clinical Research Scientist. • 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.

Requirements

• 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. • Ability to travel to as needed.