Clinical Data Manager

🔥 0 minutes ago

🌐 Mexico, Argentina, +1 more countries – Remote

🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead a small clinical study or co-lead larger studies with moderate guidance • Support several clinical studies with minimal guidance • Manage and monitor data management activities with CROs and other vendors • Review protocols for data capture, including eCRF design and data requirements • Interact with CRAs, programmers, study managers, and statisticians on eCRFs and CRF guidelines • Develop data edit check specifications and run data listings • Coordinate design and testing of EDC systems • Resolve EDC system issues with team members • Develop the Data Management Plan for clinical studies • Review and provide feedback on clinical, statistical, and vendor study documents • Enter and manage data queries in EDC systems • Reconcile header data and Serious Adverse Events against clinical databases • Assist with database upgrades and migrations, including User Acceptance Testing • Maintain study workbooks and data management files • Perform database lock and freeze activities • Participate in team meetings and provide input • Contribute to data management SOPs, work instructions, and process documents • Assist with training new employees and contractors • Collaborate with cross-functional teams to design data collection strategies and resolve queries throughout clinical trials • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• 5+ years of experience in Data Management for the pharmaceutical/biotechnology industry or equivalent FDA-regulated environment • Understanding of Phase 1–4 clinical studies • Proven ability to perform core Data Management tasks and interact with vendors • Understanding of regulatory guidelines and industry standards, including ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries • Experience with Oncology or CNS therapeutic areas is desirable • Experience with Phase III pivotal studies is desirable • Strong English written and verbal communication skills • Bachelor’s Degree required in a scientific/healthcare field • Master’s Degree preferred • Working knowledge of Parexel processes, ICH-GCPs, and other applicable requirements