Senior Clinical Data Manager – FSP

🔥 32 minutes ago

🌐 Mexico, Argentina – Remote

🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 large clinical studies or related series of studies with minimal guidance • Represent Data Management on the CTWG for assigned studies • Mentor and train lower-level Data Management staff • Manage and monitor Data Management activities with CROs and vendors • Review protocols for appropriate data capture and eCRF design • Review eCRF data requirements • Collaborate with CRAs, programmers, study managers, and statisticians on eCRFs, annotated eCRFs, and CRF completion guidelines • Lead development of data edit check specifications and data listings • Coordinate design and testing of EDC systems and resolve system issues • Develop or lead development of Data Management Plans • Review and provide feedback on clinical team documents, including monitoring plans, statistical analysis plans, and vendor specifications • Provide EDC and/or eCRF completion guidelines training • Reconcile external header data and Serious Adverse Events against the clinical database • Lead database upgrades and migrations, including User Acceptance Testing • Maintain study workbooks and Data Management files • Perform database lock and freeze activities according to SOPs • Participate in team meetings and contribute to SOPs, work instructions, and process documents • Assist with training new employees and contractors

🎯 Requirements

• At least 8 years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience • Good project management skills and proven ability to multitask • Understanding of Phase 1-4 clinical studies and ability to perform core Data Management tasks and interact with vendors • Comprehensive understanding of regulatory guidelines and industry standards, including ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, and WHO Drug Dictionaries • Attention to detail and ability to work individually, within a multidisciplinary team, and with external partners and vendors • Strong English language written and verbal communication skills • Experience and understanding of Oncology or CNS therapeutic area and Phase III pivotal studies preferred • Ability to travel to off-site meetings or training seminars as needed • Solid computer system and technical skills, ability to learn multiple computer applications, and experience with Data Management and Electronic Data Capture systems desirable • BA/BS, preferably in the scientific/healthcare field

🏖️ Benefits

• Full-time employment • Opportunity to contribute to therapies benefiting patients • Training and mentoring opportunities • Participation in a professional, multidisciplinary environment