Experience Requirements:
- Bachelors in life sciences or related discipline with 8-10 years of experience in clinical and drug development
- Clinical or biological laboratory experience with involvement in the processing and/or analysis of a biological sample
- Extensive clinical trial management experience from study start-up through to close out, particularly in oncology and/or precision medicine early drug development.
- Familiar with oncology laboratory terminologies as well as genomic biomarker and pharmacodynamic endpoints from tissue and blood samples
- Early phase oncology trial management experience preferred
- Thorough knowledge of FDA and ICH/GCP regulations and guidelines
- Self-motivated and takes pride in your work
What you’ll do:
- Develop and maintain effective, collaborative relationships with SETs, CROs and laboratory service providers and other key stakeholders
- Manage key service providers (eg, Central and other laboratories as needed) and CROs to support clinical sample tracking and collection, and sample storage including drafting and reviewing RFPs, vendor selection, defining scopes of work, vendor management, and contract management in support of study objectives and goals
- Implement study-specific biosample analysis plan and data management or transfer agreement for each study
- Support the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data reconciliation and transfer, and final sample disposition, in accordance to study protocol and informed consent
- Collaborate with clinical biomarker operations and pharmacology to oversee all study biosample operational activities and regularly report on status (including reconciling against consent)
#INDGG
Job Types: Full-time, Contract
Pay: $80.00 - $95.00 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Vision insurance
Education:
Experience:
- Clinical Trial: 1 year (Required)
- Early Phase Oncology: 1 year (Required)
Work Location: Remote
