Senior Specialist, Biospecimen Operations

Senior Specialist, Biospecimen Operations in Redwood City, California Overview 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. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s