Senior Clinical Data Associate – FSP

🔥 1 minute ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

✨ Associate

👻 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 a small clinical study or co-lead larger studies with moderate guidance • Support multiple clinical studies while ensuring high standards of data quality and delivery • Manage and monitor data management activities performed by CROs and external vendors • Review study protocols and evaluate data capture requirements, including eCRF design • Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines • Develop data edit check specifications and generate study data listings • Coordinate the design, testing, and issue resolution of Electronic Data Capture systems • Develop and maintain study Data Management Plans and supporting documentation • Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities • Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities • Maintain study workbooks and data management files while ensuring inspection readiness • Contribute to the development and improvement of data management SOPs, work instructions, and process documentation • Partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data collection, review, reconciliation, and database management

🎯 Requirements

• Bachelor's Degree in a scientific or healthcare-related field • At least five years' experience in Data Management within the pharmaceutical or biotechnology industry • Experience working within clinical research and regulated pharmaceutical or biotechnology environments • Understanding of Phase I-IV clinical studies • Demonstrated ability to perform core Data Management activities and work with vendors • Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and related industry standards • Experience with Electronic Data Capture systems and clinical data management technologies • Strong communication, organization, technical, and problem-solving skills • Experience in Oncology or CNS therapeutic areas preferred • Experience supporting Phase III pivotal studies preferred • RAVE experience strongly preferred

🏖️ Benefits

• Medical Aid Contribution • Gap Cover • Life Assurance • Provident Fund (8%) • 13th Cheque • Flexibility • Growth opportunities