Job Details

Senior Specialist Biospecimen Operations

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.