Senior Specialist, Biospecimen Operations

Senior Specialist, Biospecimen Operations at Planet Pharma Senior Specialist, Biospecimen Operations at Planet Pharma in Atherton, California Posted in 3 days ago.

Type:

full-time

Job Description:

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

Required Skills, Experience and Education:

Life sciences degree (BS or MS) in 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, 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 resolution of problems. Ability to multi-task and thrive in a fast-paced innovative environment. A great teammate, who listens effectively and invites response and discussion. Commitment to

Core Values:

Tireless Commitment to Patients, Transformative Science, Exceptional Together, Total Integrity, Inclusiveness and Fairness.

Preferred Skills:

Experience in using Project Management tools is desirable.