Parexel International Corporation
FSP Precision Medicine Operations Lead (Remote)
Parexel International Corporation, Billerica, Massachusetts, us, 01821
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 sites, and project managers (central and/or specialty labs) 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.
JOB RESPONSIBILITIES
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 JOB REQUIREMENTS This role may be for you if:
Excellent written and verbal communication skills Ability to handle and resolve problems on the fly as well as strong project management and organizational skills Ability to work independently and proactively while still contributing to group initiatives and goals Strong interpersonal skills and ability to work with many different groups/teams to achieve success EDUCATION To be considered for this role, you must have a B.S degree - Major/ Minor (Biology or equivalent). 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.
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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 JOB REQUIREMENTS This role may be for you if:
Excellent written and verbal communication skills Ability to handle and resolve problems on the fly as well as strong project management and organizational skills Ability to work independently and proactively while still contributing to group initiatives and goals Strong interpersonal skills and ability to work with many different groups/teams to achieve success EDUCATION To be considered for this role, you must have a B.S degree - Major/ Minor (Biology or equivalent). 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.
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