Biomarker Data Specialist Jobs

• Support laboratory data management procedures including authoring and reviewing data transfer plans, overseeing data transfers, processing and storage of data. Use templates and standard guidelines to initiate documents but exercises critical thinking and discretion to tailor documents to study needs.
• Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables
• Assist lead Biomarker Data Specialists to create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure meet end user needs.
• Support data cleaning activities for lab data reconciliation. Research and resolve discrepancies of moderate complexity.
• With guidance, assist in managing multiple project streams by coordinating with internal and external stakeholders concerning timelines and deliverables. Internal stakeholders may include Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Specimen Coordinators, Clinical Project Managers and others. External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others.
• Work with internal and external stakeholders to coordinate specimen testing in accordance with study plans and timelines.
• Maintain an integrated tracking and inventory log of all specimens collected during a clinical trial, interpret data and share metrics with stakeholders.

• With some oversight, create detailed specifications for tabular and unstructured data by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meet end user needs.
• Utilize problem-solving skills when working with vendors and collaborators to drive projects forward, seeking guidance when needed.
• Draft, revise, and provide feedback on contracts and study documents to ensure alignment with stakeholders needs, internal processes and vendor capabilities.
• Assist in maintenance of department tools, templates, and systems.
• Run SAS programs, review SAS logs, and generate output.
• Work with external labs and internal stakeholders to troubleshoot issues and implement process improvements of moderate scope.
• Conduct data cleaning activities for vendor data reconciliation with minimal guidance. Exercise discretion and seek guidance as needed to choose efficient and effective issues resolution paths.

• Years of experience: 0 – 5 years; dependent on level of related skills and education
• Working knowledge of the clinical drug development process
• Preferred:
• Previous sample tracking and/or handling experience
• Proficiency with Excel
• Flexible, easily adapts to change, and is energized by challenges and problem-solving
• Prior experience writing specification documents and/or work instructions
• Laboratory background and/or working knowledge of commonly tested biomarkers in the oncology setting, latest and advanced analytical tools and assays
• Effective time management skills and ability to prioritize successfully
• Previous Electronic Data Capture (EDC) experience
• Excellent written/verbal communication skills
• Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development and UAT
• Detail oriented; performs quality and accurate work
• Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession
• Ability to coordinate multiple projects and tasks
• Previous LIMS (Laboratory Information Management System) experience

• Oncology experience and/or working knowledge

Education

• BA/BS in relevant field; years of experience may substitute for education

Competencies

• Nimble learning
• Cultivates innovation
• Collaborates
• Tech savvy
• Action oriented
• Communicates effectively
• Balances stakeholders
• Customer focus
• Manages complexity
• Decision quality
• Manages ambiguity