3170 Porter Drive Palo Alto, CA 94304 US
We are seeking a highly motivated Clinical Scientist Contractor who will be supporting ongoing Hematology/Oncology Clinical program as Clinical Scientist in a cross-functional team and Clinical Development department. The candidate will play a key role in guiding different protocol development and clinical trial execution and data monitoring, data review, and reporting, assisting with regulatory filing, and contributing to all other clinical Science aspects of the assigned clinical studies.
Key Responsibilities Include:
Assist in drafting and presenting protocols and clinical study essential documents
Participate and provide support to cross-functional teams, including medical Monitor and other clinical scientists
Communicate with cross functional teams to ensure alignment in projects management throughout the course of the clinical study
Work closely to assess study progress, ensure proper study conduct and adherence to the protocol
Closely work with study team to review, evaluate, and communicate data and provide guidance in routine data review and query resolution in EDC.
Assist in preparation of various data summary, study report, and presentations as needed to support key study milestone decisions and/or regulatory filing.
Participate in the implement of clinical policies, and SOPs
Support clinical initiatives to improve the quality and content of all clinical programs
Review cross-functional/organization processes as needed to effectively deliver results in clinical portfolio
Preferred Education and Experience
PhD, PharmD, or MS degree in in medical or life science major.
2-4 years of working in drug development programs with 2+ years in clinical development experiences at a pharmaceutical, biotechnology, or CRO company
Hematology, oncology or immunology experience preferred
Experience in leading clinical data monitoring, querying, analysis, and reporting
Working knowledge of FDA/EMEA requirements, good clinical practices, and pharmaceutical clinical development in oncology
Ability to interact with investigators and CROs as a scientific representative
Ability to set priorities for team and maintain accountability
Knowledge of Good Clinical Practice (GCP) and Good Clinical Data Management Practices (GCDMP)
Must be able to work independently
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