BIOMARKER OPERATIONS AND SAMPLE MANAGEMENT SPECIALIST
Planet Pharma
Redwood City CA 94061 US
Biomarker Operations and Sample Management Specialist
The Opportunity:
Playing a critical role as a Biomarker Operations and Sample Management Specialist 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.
Operationalize the CDx strategy to support early and late-stage development of portfolio assets.Effectively collaborate with biomarker scientists and clinical operations to ensure successful collection and CDx testing of clinical trial samples.Collaborate with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.Work closely with Clinical operations group for central lab set up, including kit design, sample processing instructions and logistics.Work closely with biomarker scientists to oversee development of the scope of work, budgets, and timelines by CROs.Assist in sample reconciliation between central labs and biomarker vendors/CROs.Perform day-to-day operational management of CROs to ensure timely delivery with high standard of quality.Provide sample and assay status updates to biomarker and diagnostic sub-teams.
Education, Experience and Skills Requirement:
Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.3+ 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.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.
Preferred Skills:
Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.Experience in using Project Management tools is desirablePrior experience in clinical biomarker operation and/or sample management in phase three clinical trials is highly desirable.
The Opportunity:
Playing a critical role as a Biomarker Operations and Sample Management Specialist 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.
Operationalize the CDx strategy to support early and late-stage development of portfolio assets.Effectively collaborate with biomarker scientists and clinical operations to ensure successful collection and CDx testing of clinical trial samples.Collaborate with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.Work closely with Clinical operations group for central lab set up, including kit design, sample processing instructions and logistics.Work closely with biomarker scientists to oversee development of the scope of work, budgets, and timelines by CROs.Assist in sample reconciliation between central labs and biomarker vendors/CROs.Perform day-to-day operational management of CROs to ensure timely delivery with high standard of quality.Provide sample and assay status updates to biomarker and diagnostic sub-teams.
Education, Experience and Skills Requirement:
Life sciences degree (BS or MS) in scientific, medical, healthcare, or related discipline.3+ 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.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.
Preferred Skills:
Should be proficient in Microsoft Excel, Microsoft PowerPoint applications.Experience in using Project Management tools is desirablePrior experience in clinical biomarker operation and/or sample management in phase three clinical trials is highly desirable.