Clinical Research Scientist
4 weeks ago
The Role
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.
Responsibilities
- 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 (ie, 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.
For this role at Genmab, we are seeking a highly skilled and experienced Clinical Research Scientist to join our team. The ideal candidate will have a strong background in clinical research and a passion for delivering high-quality results in a fast-paced environment.
About Genmab
Genmab is a biotechnology company that leverages the effectiveness of an agile working environment to connect employees and foster innovation. Our state-of-the-art laboratories and collaborative office spaces provide a dynamic and supportive environment for our team members to thrive.
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