Clinical Assays Operations Manager

Do you want to work in a company that is empowering the globalpopulation with a healthier future through the delivery of innovativeand affordable medical solutions? Clover Biopharmaceuticals’ vision isto deliver next-generation solutions to empower the global populationwith a healthier future. Our mission is to leverage our cutting-edgeTrimer-Tag™ technology platform and fully integrated manufacturingcapabilities for the discovery, development, and delivery of innovativeand affordable medical solutions.


Key Responsibilities:
 Support global objectives of Clinical Development, Assay strategyLead(s) and VP of Clinical Operations in every aspect of clinical sampletesting.
 Review clinical trial lab manuals and preparing Serology testing plansto meet the endpoint objectives of clinical trials.
 Partner with clinical operations manager and study medical director toimplement the Serology testing plan for the clinical endpoints instudies, in compliance with GCP-ICH guidelines.
 Draft and execute contracts, work orders with bio-analytical vendorlabs, based on Serology testing plans. • Oversee and manage Serologybudget of clinical sample testing for all studies of the program.
 Responsible for sample management for the clinical study withoversight of shipment conditions and timing from the clinical site tothe central laboratory, delivery of samples to the bio-analyticalvendor, testing, reconciliation, data transfer, and final long-termstorage or further use of clinical samples.
 Manage and perform periodic quality check of the trial master file(TMF) documents owned by Serology in accordance with regulatoryrequirements and Quality management system.


Requirements:
 MS with a minimum of 3 years or BS with a minimum of 5 yearsdemonstrated excellence in project/program management work in thepharmaceutical environment and/or work with vaccines. Practicallaboratory experience desirable
 Experience and demonstrated success in vendor management, includingcoordination and tracking of timelines and payments
 Have exceptional communication skills with ability to communicateclearly with global operating matrix team
 Fluent in spoken and written English.
 Good knowledge and understanding of GMP, ICH-GCP and GCLP guidelinesfor clinical development of vaccines
 Experience in working with document management system and electronictrial master file (e-TMF) systems used for archiving clinical studydocuments


For more information, please visit our website: ********