Position Summary: We are seeking a highly motivated Biosample Operations Manager with a passion for new cancer therapy development. This role will be responsible for providing leadership to Clinical Development Execution and/or Study Management Team and oversight of laboratory vendors for our clinical programs. As a Biosample Operations Manager, you will represent Clinical Operations and work directly with Biomarker Sciences, Pharmacology, Clinical Data Management, Medical Monitor, and other key functions both internally and externally to ensure successful completion of all clinical activities/project deliverables. You will apply your technical skills, learn new skills, and play a key role in clinical trial planning and execution. As a member of the team, you will help to grow the pipeline.
What you'll do:
- Develop and maintain effective, collaborative relationships with internal study execution/management teams, CROs, laboratory service providers, and other key stakeholders.
- Manage key service providers (e.g., 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.
- Lead the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data reconciliation and transfer, to final sample disposition, in accordance with study protocol and informed consent.
- Collaborate with biomarker sciences and pharmacology to oversee all study biosample operational activities and regularly report on status (e.g., reconciling against consent) including Key Performance Indicators.
- Support biomarker sciences and clinical development on Companion Diagnostics strategy development and lead the study execution on the strategy.
- Facilitate resolution of sample and data discrepancies.
- Write or contribute to the preparation of clinical documents (e.g., protocols, informed consent forms, case report forms, laboratory specifications, and manuals).
- Provide education and training for sample collection, handling, and shipment, which may include optimization of laboratory manuals, contributing to the development of patient and site-friendly sample collection materials, to investigators and site staff, vendor staff, and team members.
- Proactively identify areas of best practice and process improvements. Participate and/or lead Biosample Operations initiatives.
Requirements:
- Bachelor's 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 biological samples.
- 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.
- Results-oriented team player; enjoy working collaboratively with colleagues and building positive relationships.
- Detailed oriented and creative thinker with a passion for process optimization.
- Excellent organizational and communication skills.
- Computer software literate, e.g., Microsoft suite including MS Excel and MS Project, Smartsheet, Adobe, and other clinical systems such as EDC, CTMS, TMF.
- Analyze and triage problems, prioritize accordingly, and propose solutions.
If you are passionate about making a difference in the field of oncology and meet the above requirements, we would love to hear from you!
