Clinical Scientist assists the study team addressing protocol questions, including preparation of clinical study protocols, patient informed consents, and other core documents which are central to clinical trial conduct.
Job responsibilities includes, but are not limited to, the following:
- Assist the medical monitor with regular and ad-hoc data reviews and interpretation; prepare and present summaries/documentations of these reviews
- Support the medical monitor with the development of program-level documents
- Collaborate with the medical monitor to identify any trial-related safety trends
- Support the medical monitor with review and contributions to trial-related documents such as the statistical analysis plan, the data management plan, & the medical monitoring plan
- Assist the medical monitor with protocol deviation review
- Assist Clinical Operations with developing the operational strategies for clinical research studies and development programs (e.g. PI selection, CRO selection, budgets)
- Manage trial-related committees
- Assist with protocol and study conduct training and with responding to regulatory questions
- Responsible for compiling clinical content and maintenance of various clinical components of regulatory documents
- Effectively collaborate with cross-functional internal groups and external partners, as well as work effectively with external key opinion leaders and investigators.
- Ensures that the clinical elements of documents are of quality, accuracy and format and comply with laws, regulations, and corporate standards.
Qualification & Competencies:
Experience in patient data cleaning and review of adverse events required. Attention to detail is a must. An ability to interpret, discuss, and report trial / program level data effectively and identify trends is also required.
Strong verbal and written communication skills is a must, and ability to present scientific study data and results. Strong organizational skills and an ability to take the initiative and be flexible in resolving problems as necessary.
Team player with excellent interpersonal skills and ability to work effectively in a multicultural and cross-functional team environment. Capable of managing multiple priorities, and able to exercise sound judgment, work under pressure and produce accurate and timely work within a highly regulated environment.
- Master's Degree in Sciences/Pharmacy/Nursing
- PhD, PharmD, MD or equivalent is preferred
- Minimum of 3 years related industry experience including working with and supporting medical monitors and/or project safety teams