Clinical Laboratory Study Manager
hace 3 semanas
Parexel is looking for a CLSM to join our FSP division Candidates can be based anywhere in Argentina or Brazil . Overview The Clinical Laboratory Study Manager works with the Precision Medicine Strategy Lead as well as clinical study teams, data management (DM) team, Samples, Kits, Data, Logistics (SKDL) and Clinical Laboratory Project Management (CLPM) groups to ensure quality samples and data are delivered to support biomarker and non-biomarker evaluation and enable the translation of science to medicine. The role will work closely with project managers (central and/or specialty labs) and lend expertise to clinical trial management (CTM) and CRO to ensure samples are collected per protocol and assist with resolving any sample related issues or queries. Additional responsibilities include overall project management in alignment with the core business strategy. Responsibilities Supports individual clinical study teams as required for all technical and operational sample-related matters for assigned projects by liaising with internal stakeholders, such as working with Informed Consent Form (ICF) specialist in SKDL on ICF and other trial documents impacting samples and testing. Establishment, oversight, planning, and integration of all issues related to collection, processing, storage, shipping and transfer of samples and data, as well as reporting/billing for study related operations. Liaises with Precision Medicine Strategy Leads and other scientists by assessing vendors, forecasting sample operational costs, timelines and reviewing invoices to ensure alignment with budget plans. Works closely with data management lead to determine how sample and testing data will be captured, blinded and transferred for clinical trials. Provides guidance to clinical teams and clinical sites regarding collection, storage, and shipping of samples acquired in the course of clinical trials or other human sample acquisition projects. Works with scientists and clinical team to ensure sample collection and usage is in compliance with study protocol and applicable ICF. Works closely with internal Human Sample Management team to ensure all samples transferred to internal research groups are documented, tracked, used and destroyed. Complies with required training curriculum, completes timesheets accurately, submits expense reports, updates CV, and maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery. Skills Excellent written and verbal communication skills. Resolve problems spontaneously and possess strong project management and organizational skills. Work independently and proactively while still contributing to group initiatives and goals. Good interpersonal skills and ability to work with many different groups/teams. Proficiency in Microsoft applications. Knowledge and Experience 6 - 8 years clinical research experience with academic, CRO or pharmaceutical/biotech industry. Seeking a professional with working knowledge of clinical trials and clinical databases. Laboratory sample management experience is a plus. Education Bachelor’s degree in a life science, nursing qualification or other relevant experience required. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care Referrals increase your chances of interviewing at Parexel by 2x. #J-18808-Ljbffr
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