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PAREXEL International LLC Precision Medicine Operations Lead- FSP in United States
My research opens up new medical possibilities.
And I do it
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Precision Medicine Operations Lead- FSP United States of America, Remote Additional Locations: Remote - United States of America Job IDR0000024528 CategoryClinical Trials
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About this Role
Works with Precision Medicine Strategy Lead as well as clinical study teams to ensure quality samples and data are delivered to support biomarker evaluation and delivery of science to medicine. Responsibilities include oversight of clinical sample collection, usage per informed consent form, sample tracking (chain of custody) and sample destruction. Individual will work closely with internal and external groups/vendors to manage and support the generation of quality biomarker data. Will work closely with clinical sites and project managers (central and/or specialty laboratories) to ensure samples are collected per protocol and to resolve any sample related issues or queries. Additional responsibilities include overall project/portfolio management and alignment amongst studies.
Key Accountabilities:
Accountability
Supporting Activities
Compliance with Parexel standards
Comply with timely completion of required training curriculum
Complete timesheets accurately as required (weekly)
Submit expense reports as required (within 30 days)
Update CV as required
Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements
Study Team Support
Participates in cross-functional study teams and sub-teams across clinical and research sides of the company
Works with clinical study team on the development of the ICF, including escalations from IRBs/ECs
Manages acquisition of clinical trial samples designated for biomarker research (including human tissue, whole blood, plasma, serum, etc)
Operational Support of Biomarker and Exploratory Analysis
Establishment, oversight, planning, and integration of all issues related to bio sample processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations
Liaises with Precision Medicine Strategy Leads by assessing vendors, forecasting the biomarker sample operational costs, timelines and reviewing invoices to ensure we are aligned with budget plans
Data Acquisition and Management
Works closely with data management lead to determine how biomarker data will be captured, blinded and transferred for clinical trials.
Enables transfer of biomarker/exploratory data from vendor through development and review of an appropriate data transfer specification and related documents
Human Sample Management Flow and Compliance
Provides guidance to clinical teams and clinical sites regarding collection and storage of biospecimen acquired in the course of clinical trials or other human sample acquisition projects
Works with Precision Medicine Strategy Leads and clinical team to ensure sample collection and usage is in compliance
Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed
Skills:
Excellent written and verbal communication skills
Analytical problem-solving experience
Problem solving abilities, troubleshooting and resourcefulness
Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA and/or local country regulations as applicable
Effective communication and interpersonal skills
The ability to build relationships internally and externally
Familiarity with medical terms
Demonstrates writing skills to deliver messages effectively so messages are clearly understood
Proficiency in Microsoft Office applications
Knowledge and Experience:
6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. We are seeking a working knowledge of the clinical trials and clinical databases.
Education:
BS degree required–Major/ Minor (Biology or equivalent)
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.