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Responsibilities
Parexel FSP is hiring for multiple Clinical Data Manager positions in Mexico, Argentina, Canada (all locations) and/or Brazil.The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidanceKey Accountabilities:Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidanceBe able to support several clinical studies with minimal guidanceManage and monitor the progress of data management activities with CROs or other vendors on assigned studiesReview protocols for appropriate data capture including electronic Case Report Form (eCRF) design.Be able to perform a thoroughly detailed review of eCRF data requirements.Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.Develop data edit check specifications and run data listings as requiredCoordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team membersDevelop the Data Management Plan for a clinical study.Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specificationsEnter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queriesPerform reconciliation of header data from external data sources against the clinical databasePerform Serious Adverse Event reconciliation activities according to SOPs and guidelinesAssist in database upgrades/migrations including performing User Acceptance TestingAble to maintain study workbooks and data management filesPerform database lock and freeze activities per company SOPsParticipate in regular team meetings and provide input when appropriateProvide input into the development of data management SOPs, Work Instructions, and process documentsContribute to a professional working environment including the application of the client’s Code of Business Conduct and EthicsAssist with the training of new employees and/or contractorsCollaborative relationshipsCollaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.Compliance with Parexel standardsComplies with required training curriculumCompletes timesheets accurately as requiredSubmits expense reports as requiredUpdates CV as requiredMaintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsKnowledge and Experience:5+ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environmentUnderstands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.Possesses strong English language written and verbal communication skills.Education:Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field.Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere.Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.
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