Clinical Laboratory Study Manager - BCMA
Behavioral Health Market Context
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Job Description
anagers from central and specialty labs, providing crucial support for clinical trial management and ensuring that samples are collected according to protocol while addressing any related issues or queries.
Key Responsibilities:
Operational Management:
• Offer comprehensive technical and operational support regarding samples for clinical study teams, collaborating with internal stakeholders, including the Informed Consent Form (ICF) specialists.
Sample Analysis Operational Support:
• Establish, oversee, and integrate all aspects related to the collection, processing, storage, shipping, and transfer of samples and data, including billing and reporting for study operations.
• Work alongside Precision Medicine Strategy Leads and scientists to assess vendors, forecast operational costs, and review financial alignment with budget plans.
Data Management:
• Collaborate with data management to determine how sample and testing data will be collected, blinded, and transferred throughout clinical trials.
Sample Management and Compliance:
• Guide clinical teams and sites on the collection, storage, and shipping protocols for samples obtained during trials or other projects.
• Ensure that sample collection and usage comply with study protocols and applicable ICFs in collaboration with scientists and clinical teams.
• Coordinate with the Human Sample Management team to document, track, and manage the lifecycle of samples transferred to internal research groups.
Adherence to Standards:
• Complete all required training and maintain up-to-date knowledge.
• Ensure accurate and timely completion of timesheets and expense reports.
• Keep your CV updated and maintain productive relationships across platform lines, Business Units, and enabling lines to enhance portfolio delivery.
Qualifications:
We are looking for candidates with:
• 6 - 8 years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings.
• Working knowledge of clinical trials and clinical databases.
• Laboratory sample management experience is a plus.
Education:
A Bachelor's degree in a life science, nursing qualification, or relevant experience is required.
#LI-LO1
#LI-REMOTE
Parexel is an equal opportunity employer and welcomes applications from individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Key Responsibilities:
Operational Management:
• Offer comprehensive technical and operational support regarding samples for clinical study teams, collaborating with internal stakeholders, including the Informed Consent Form (ICF) specialists.
Sample Analysis Operational Support:
• Establish, oversee, and integrate all aspects related to the collection, processing, storage, shipping, and transfer of samples and data, including billing and reporting for study operations.
• Work alongside Precision Medicine Strategy Leads and scientists to assess vendors, forecast operational costs, and review financial alignment with budget plans.
Data Management:
• Collaborate with data management to determine how sample and testing data will be collected, blinded, and transferred throughout clinical trials.
Sample Management and Compliance:
• Guide clinical teams and sites on the collection, storage, and shipping protocols for samples obtained during trials or other projects.
• Ensure that sample collection and usage comply with study protocols and applicable ICFs in collaboration with scientists and clinical teams.
• Coordinate with the Human Sample Management team to document, track, and manage the lifecycle of samples transferred to internal research groups.
Adherence to Standards:
• Complete all required training and maintain up-to-date knowledge.
• Ensure accurate and timely completion of timesheets and expense reports.
• Keep your CV updated and maintain productive relationships across platform lines, Business Units, and enabling lines to enhance portfolio delivery.
Qualifications:
We are looking for candidates with:
• 6 - 8 years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings.
• Working knowledge of clinical trials and clinical databases.
• Laboratory sample management experience is a plus.
Education:
A Bachelor's degree in a life science, nursing qualification, or relevant experience is required.
#LI-LO1
#LI-REMOTE
Parexel is an equal opportunity employer and welcomes applications from individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Qualifications
- •6 - 8 years of clinical research experience in academic, CRO, or pharmaceutical/biotech settings
- •Working knowledge of clinical trials and clinical databases
- •A Bachelor's degree in a life science, nursing qualification, or relevant experience is required
Benefits
Responsibilities
- •Join our team as a Clinical Laboratory Study Manager, where you will collaborate closely with the Precision Medicine Strategy Lead and clinical study teams to ensure the delivery of high-quality samples and data that support both biomarker and non-biomarker evaluations
- •Your expertise will help translate innovative science into effective medical solutions
- •You will work hand-in-hand with project managers from central and specialty labs, providing crucial support for clinical trial management and ensuring that samples are collected according to protocol while addressing any related issues or queries
- •Offer comprehensive technical and operational support regarding samples for clinical study teams, collaborating with internal stakeholders, including the Informed Consent Form (ICF) specialists
- •Sample Analysis Operational Support:
- •Establish, oversee, and integrate all aspects related to the collection, processing, storage, shipping, and transfer of samples and data, including billing and reporting for study operations
- •Work alongside Precision Medicine Strategy Leads and scientists to assess vendors, forecast operational costs, and review financial alignment with budget plans
- •Collaborate with data management to determine how sample and testing data will be collected, blinded, and transferred throughout clinical trials
- •Sample Management and Compliance:
- •Guide clinical teams and sites on the collection, storage, and shipping protocols for samples obtained during trials or other projects
- •Ensure that sample collection and usage comply with study protocols and applicable ICFs in collaboration with scientists and clinical teams
- •Coordinate with the Human Sample Management team to document, track, and manage the lifecycle of samples transferred to internal research groups
- •Adherence to Standards:
- •Complete all required training and maintain up-to-date knowledge
- •Ensure accurate and timely completion of timesheets and expense reports
- •Keep your CV updated and maintain productive relationships across platform lines, Business Units, and enabling lines to enhance portfolio delivery
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