We have a current opportunity for a Clinical Research Scientist on a contract basis. For further information about this position please apply.
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.
The responsibilities include but are not limited to:
- 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)
- Assist with the development of a trial protocol and to other study-related and regulatory documents
- Assist in the development of case report forms (eCRFs), eCRFs completion guidelines, and provide scientific support for other key data management deliverables (eg 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
- Participate in country/site selection, feasibility assessment and engage in KOL interaction
- Assist 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)
- Assist in the development and review of study plans and serve as a liaison to project teams and CROs
- Assist to prepare presentations for Investigator meetings, CRO/CRA training, SIVs as warranted
Qualifications:
- Bachelor's degree or equivalent and 3+ years of industry related experience (oncology experience is preferred)
- Strong knowledge and understanding of clinical data review
- Proven experience working in teams
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines
- Ability to be proactive, enthusiastic and goal orientated
- A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (eg Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy
- Strong communication skills - both oral and written