Senior Specialist, Biospecimen Operations

Senior Specialist, Biospecimen Operations

W2 Contract

Pay Rate: $50 - $60 per hour

Location: Redwood City, CA - Hybrid Role

Job Summary:

Playing a critical role as a Senior Specialist Biospecimen Operations within the Translational Medicine function, the position will provide biomarker operational expertise in developing the scope of work and maintaining effective working relationships with cross-functional teams for phase three clinical trials.

Duties and Responsibilities:

• Lead biomarker sample operations across clinical studies, including protocol planning, testing strategy, data management, and documentation.
• Collaborate with Biomarker Leads and Clinical Operations on protocol, ICF, eCRF, and eTMF reviews.
• Oversee central lab activities: budget and SOW reviews, lab manual and site requisition form reviews.
• Partner with QA for vendor onboarding related to biomarker testing, data analysis, and sample storage.
• Manage relationships with central/specialty labs and Biobank, coordinate study contracts, meeting discussions, review invoices, and issue resolutions.
• Develop and maintain tracking systems for sample logistics and data generation.
• Contribute to SOP development and biomarker program initiatives.
• Support TM deliverables, including interim analyses, CSRs, and regulatory filings.
• Help manage biomarker operations budgets, identify and mitigate sample/data handling risks.
• Independently lead biomarker operations for Phase III oncology trials.
• Oversee vendor selection and participate in audits.
• Engage cross-functional teams and provide Biomarker metrics and updates.
• Utilize IRT systems and present biomarker strategies to senior leadership.

Requirements and Qualifications:

• Life sciences degree (BS or MS) in a scientific, medical, healthcare, or related discipline.
• 5+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory.
• Prior experience in clinical biomarker operation and/or sample management in phase three clinical trials is highly desirable.
• Excellent scientific and business communication skills, strong interpersonal/collaboration skills, and planning skills.
• Should be proficient in Microsoft Excel and Microsoft PowerPoint applications.
• Experience in using Project Management tools is highly desired.
• Ability to think critically and creatively, and be able to work independently to determine appropriate resources for the resolution of problems.
• Ability to multitask and thrive in a fast-paced, innovative environment.
• A great teammate who listens effectively and invites response and discussion.
• Commitment to Revolution Medicines' Core Values: Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness, and Fairness.

Preferred Qualifications:

• Experience in using Project Management tools is desirable.

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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