Seeking a Biomarker Associate III / Clinical Biomarker Operation Manager for a 12 month assignment in Redwood City, CA.
The Immuno-Oncology Clinical Biomarker group uses advanced methods to discover biomarkers and implement Translational Medicine strategies in early clinical studies to progress innovative Oncology pipeline. We are currently seeking a highly motivated individual to join our Biomarker Operations team to support the implementation of Clinical Biomarker strategies. As a member of project teams, he/she will have the opportunity to work in a highly collaborative environment to support projects across Oncology Early Development with a focus on Immuno-Oncology.
Key Responsibilities Include: Provide hands-on support to enable biomarker assay implementation in clinical trials, including sample and data management, and CRO management. Review Clinical Biomarker sections in key clinical documents including Protocols, Informed Consent Forms, Contracts, and Clinical Study Reports. Prrovide input into trial-specific agreements and statements of work with vendors. Provide operation support to Biomarker Leads to ensure the delivery of bio-sample data in accordance with study timelines. Maintain open and frequent communication with various functions such as Clinical Operations. Maintain a positive working relationship with internal/external customers. May assist CRA in training sites on sample collection/handling. Adhere to applicable country regulations, legal requirements, Good Clinical Practices GCPs , ICH Guidelines, Standard Operating Procedures SOPs .
Basic Qualifications: Bachelor s Degree in a scientific discipline with 5+ years of related industry and/or academic work experience.
Preferred Qualifications: Proficient in the conduct of clinical trials and associated activities and responsibilities, as well as experience interacting with clinical trial teams; strong background in oncology a plus. Previous experience with Clinical Biomarker Operations. Proven strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with multiple high priority competing projects and deadlines. Excellent communication and interpersonal skills, including problem solving, crisis management, change management, and conflict resolution. Proactive and positive team player. Able to work in a cross-functional team environment, interacting with various levels within the organization as well as vendors/academic sites. Possesses strong oral and written communication skills; proven ability to successfully negotiate with and influence stakeholders with tact and diplomacy. Knowledge of FDA and/or EMA Regulations or relevant local regulations , ICH Guidelines, and GCP governing the conduct of clinical studies. Proficient knowledge of all standard IT office tools; knowledge of LIMS systems a plus. Understanding of Translational Sciences and Companion Diagnostic development is a plus. Project Management experience a plus.
For immediate consideration, please send your resume in a WORD document to [ Email address blocked ] - Click here to apply to Clinical Biomarker Operation Manager
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