Precision Medicine Operations Manager
5 days ago
Parexel International Corporation is seeking a talented Precision Medicine Operations Manager to join our team.
The successful candidate will be responsible for overseeing the clinical sample collection, usage per informed consent form, sample tracking (chain of custody) and sample destruction. They will work closely with internal and external groups/vendors to manage and support the generation of quality biomarker data. This includes collaborating with sites, project managers (central and/or specialty labs) to ensure samples are collected per protocol and resolving any sample-related issues or queries.
Key Responsibilities:
- Study Team Support
The selected individual will participate in cross-functional study teams and sub-teams across clinical and research sides of the company. They will work with the clinical study team on the development of the ICF, including escalations from IRBs/ECs. Additionally, they will manage the 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
- Liaising with Precision Medicine Strategy Leads by assessing vendors, forecasting the biomarker sample operational costs, timelines, and reviewing invoices to ensure alignment with budget plans
Data Acquisition and Management
- Working closely with the data management lead to determine how biomarker data will be captured, blinded, and transferred for clinical trials
- Enabling the transfer of biomarker/exploratory data from vendors through the development and review of an appropriate data transfer specification and related documents
Human Sample Management Flow and Compliance
- Providing guidance to clinical teams and clinical sites regarding collection and storage of biospecimens acquired in the course of clinical trials or other human sample acquisition projects
- Working with Precision Medicine Strategy Leads and clinical teams to ensure sample collection and usage are in compliance
- Collaborating with the internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used, and destroyed
To be considered for this role, you must have a B.S degree - Major/Minor (Biology or equivalent). The ideal candidate should have 6-8 years of clinical research experience with academic, CRO, or pharmaceutical/biotech industry background. A working knowledge of clinical trials and clinical databases is essential. We estimate the salary for this position to be around $120,000-$150,000 per year, depending on location and qualifications.
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