Biomarker Operational Specialist - Aequor Technologies LLC
San Diego, CA 92121
About the Job
Job Description: POSITION SUMMARY:
" As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the *** Oncology Division, the successful candidate will play a critical role in supporting Translational Oncology strategies through operational and technical assistance for the Biomarker Clinical Assay Lead (BCAL) overseeing and managing external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.
POSITION RESPONSIBILITIES:
" Support Biomarker Clinical Assay Lead (BCAL) by providing document management and process management support
" Distribute documents to vendors, track distribution and acknowledgement/response from vendors
" Create and maintain master document list for closeout studies
" Enter vendor and bioanalytical report information into BCAT systems.
" Keep track of vendor assay validations, biomarker assay reports and sample disposition documents.
" Request regular updates to vendor contact information
" Assist with Vendor Evaluation data collection
" Maintain and track vendor qualification and oversight documentation
" Submission of documents to global document management system (GDMS) Report Loading Team
" Support BCAL in operational oversight for their supported studies
" Track vendor Master Service Agreement (MSA) expiration dates, vendor contact information, Vendor Oversight Plan (VOP) status, CLIA status, QMSO9 status, CP102 status, and qualification/audit visits
" Work with *** Trial Master File (PTMF) study owners to ensure proper attributes and functional line information is accurate for all BCAT documents loaded to PTMF
ORGANIZATIONAL RELATIONSHIPS:
" This role will interact with the following groups as part of their responsibilities: BCALs and Biomarker Operational Specialist within BCAT; Clinical bioanalytics group; Clinical Development Operations group; and external vendors performing biomarker analysis.
EDUCATION AND EXPERIENCE:
" Bachelor s degree or Master s degree in biology, molecular biology, biotechnology, or biochemistry
" Prior Experience:
o Proficiency in Microsoft Office and Communication tools, including Cloud-based services
o Attention to detail and ability to think and act proactively is critical
o Demonstrated ability to work in a highly matrixed environment, and execute multiple projects simultaneously
o Good understanding of inter-dependencies and functional line responsibilities
" A minimum of 2 years related clinical or research Lab experience.
TECHNICAL SKILLS REQUIREMENTS:
" Use of Microsoft Office and project management tools
Hard Skills:
1. Strong Org
2. Communication
3. Scientific technical
Soft Skills:
1. Software (Vizio)
Interview Process:
1st Screen Teams Bridge
2nd Panel 3-4 different groups (Teams Camera On)
Position Comments visible to Supplier: Mark-up not to exceed 45%
2-3 days on-site
" As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the *** Oncology Division, the successful candidate will play a critical role in supporting Translational Oncology strategies through operational and technical assistance for the Biomarker Clinical Assay Lead (BCAL) overseeing and managing external and internal partners involved in the implementation of clinical trial biomarkers sample analyses.
POSITION RESPONSIBILITIES:
" Support Biomarker Clinical Assay Lead (BCAL) by providing document management and process management support
" Distribute documents to vendors, track distribution and acknowledgement/response from vendors
" Create and maintain master document list for closeout studies
" Enter vendor and bioanalytical report information into BCAT systems.
" Keep track of vendor assay validations, biomarker assay reports and sample disposition documents.
" Request regular updates to vendor contact information
" Assist with Vendor Evaluation data collection
" Maintain and track vendor qualification and oversight documentation
" Submission of documents to global document management system (GDMS) Report Loading Team
" Support BCAL in operational oversight for their supported studies
" Track vendor Master Service Agreement (MSA) expiration dates, vendor contact information, Vendor Oversight Plan (VOP) status, CLIA status, QMSO9 status, CP102 status, and qualification/audit visits
" Work with *** Trial Master File (PTMF) study owners to ensure proper attributes and functional line information is accurate for all BCAT documents loaded to PTMF
ORGANIZATIONAL RELATIONSHIPS:
" This role will interact with the following groups as part of their responsibilities: BCALs and Biomarker Operational Specialist within BCAT; Clinical bioanalytics group; Clinical Development Operations group; and external vendors performing biomarker analysis.
EDUCATION AND EXPERIENCE:
" Bachelor s degree or Master s degree in biology, molecular biology, biotechnology, or biochemistry
" Prior Experience:
o Proficiency in Microsoft Office and Communication tools, including Cloud-based services
o Attention to detail and ability to think and act proactively is critical
o Demonstrated ability to work in a highly matrixed environment, and execute multiple projects simultaneously
o Good understanding of inter-dependencies and functional line responsibilities
" A minimum of 2 years related clinical or research Lab experience.
TECHNICAL SKILLS REQUIREMENTS:
" Use of Microsoft Office and project management tools
Hard Skills:
1. Strong Org
2. Communication
3. Scientific technical
Soft Skills:
1. Software (Vizio)
Interview Process:
1st Screen Teams Bridge
2nd Panel 3-4 different groups (Teams Camera On)
Position Comments visible to Supplier: Mark-up not to exceed 45%
2-3 days on-site
Source : Aequor Technologies LLC
