Bench Scientist - Pioneer Data Systems
La Jolla, CA 92121
About the Job
Position Details:
Our client, a world-leading Pharmaceutical Company in La Jolla, CA is currently looking for a Oncology Biomarker Assay Specialist to join their expanding team.
Job Title: Oncology Biomarker Assay Specialist / Hybrid Work
Duration: 12 months contract, extendable up to 36 months
Location: La Jolla, CA
This is a hybrid role in La Jolla, CA; candidates must report onsite 2-3 days per week
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Biomarker Operational Specialist
Summary:
As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the client Oncology Division, you 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.
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 Pharmaceutical Trial Master File (PTMF) study owners to ensure proper attributes and functional line information is accurate for all BCAT documents loaded to PTMF
Qualifications:
Bachelor's degree or Master's degree in biology, molecular biology, biotechnology, or biochemistry
A minimum of 2+ years of related clinical or research lab experience
Proficiency in Microsoft Office and Communication tools, including Cloud-based services
Experience with project management tools and Vizio experience
Attention to detail and ability to think and act proactively is critical
Demonstrated ability to work in a highly matrixed environment, and execute multiple projects simultaneously
Good understanding of inter-dependencies and functional line responsibilities
Schedule:
This is a hybrid role in La Jolla, CA; candidates must report onsite 2-3 days per week
Our client, a world-leading Pharmaceutical Company in La Jolla, CA is currently looking for a Oncology Biomarker Assay Specialist to join their expanding team.
Job Title: Oncology Biomarker Assay Specialist / Hybrid Work
Duration: 12 months contract, extendable up to 36 months
Location: La Jolla, CA
This is a hybrid role in La Jolla, CA; candidates must report onsite 2-3 days per week
Note:
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description:
Biomarker Operational Specialist
Summary:
As a member of the Biomarker Clinical Assay and Technology (BCAT) group within the client Oncology Division, you 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.
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 Pharmaceutical Trial Master File (PTMF) study owners to ensure proper attributes and functional line information is accurate for all BCAT documents loaded to PTMF
Qualifications:
Bachelor's degree or Master's degree in biology, molecular biology, biotechnology, or biochemistry
A minimum of 2+ years of related clinical or research lab experience
Proficiency in Microsoft Office and Communication tools, including Cloud-based services
Experience with project management tools and Vizio experience
Attention to detail and ability to think and act proactively is critical
Demonstrated ability to work in a highly matrixed environment, and execute multiple projects simultaneously
Good understanding of inter-dependencies and functional line responsibilities
Schedule:
This is a hybrid role in La Jolla, CA; candidates must report onsite 2-3 days per week
Source : Pioneer Data Systems
