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:

Education:

Experience:

Work Location: Remote

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