Biomarker Operations Specialist
4 days ago
Biomarker Operations and Sample Management Specialist
Job Summary:
We are seeking a highly skilled Biomarker Operations and Sample Management Specialist to join our Translational Medicine function. As a key member of our team, you will play a critical role in providing biomarker operational expertise, defining the scope of work, and maintaining strong working relationships with cross-functional teams for phase three clinical trials.
Key Responsibilities:
- Develop and implement CDx strategies to support early and late-stage development of portfolio assets.
- Collaborate with biomarker scientists and clinical operations to ensure successful collection and CDx testing of clinical trial samples.
- Work closely with diagnostic partners and internal cross-functional team members to ensure successful management of CDx samples.
- Manage central lab setup, including kit design, sample processing instructions, and logistics.
- Oversee the development of 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 a high-quality standard.
- Provide sample and assay status updates to biomarker and diagnostic sub-teams.
Requirements and Qualifications:
- Life sciences degree (BS or MS) in a scientific, medical, healthcare, or related discipline
- 3+ years of related professional experience in a clinical research setting and 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, strong interpersonal, collaboration, and planning skills
- Able to think critically and creatively and work independently to determine appropriate resources to resolve problems.
- Able to multi-task and thrive in a fast-paced, innovative environment.
- A great teammate who listens effectively and invites responses and discussion
- Proficiency with Microsoft Excel and PowerPoint is desirable.
- Experience in using project management tools is a plus.
Desired Skills and Experience:
Clinical research, biomarker operations, sample management, clinical trial, Excel, PowerPoint
Bayside Solutions, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.
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