Clinical Data Associate II – FSP

🔥 2 minutes ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Associate

Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of Parexel

Parexel

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 • Support global clinical research programs across Phase I-IV clinical studies • Partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data activities

🎯 Requirements

• Bachelor's Degree in a scientific or healthcare-related field • At least two years' experience in Data Management within the pharmaceutical or biotechnology industry • 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 working within clinical research and regulated pharmaceutical or biotechnology environments • Ability to collaborate effectively across multidisciplinary teams and with external partners and vendors • 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

Apply Now

Similar Jobs

🕒 6 days ago

The African Climate Foundation

11 - 50

🤝 Non-profit

Grants Associate managing grant applications, compliance, payments, and data systems for African Climate Foundation, an African-led climate change re-granting organisation.

🕒 October 6

Britannia's Gold Ltd

2 - 10

🚗 Transport

📦 Logistics

Fundraising associate building major-donor relationships and grant pipelines for Parity Homes, an equitable housing nonprofit. Supporting CEO-led cultivation from prospect research through funded commitments.

🕒 October 6

Britannia's Gold Ltd

2 - 10

🚗 Transport

📦 Logistics

Fundraising and donor relations associate securing transformational major gifts for Parity Homes. Researching prospects, managing donor cultivation, and writing grants alongside the CEO.

🕒 October 6

Britannia's Gold Ltd

2 - 10

🚗 Transport

📦 Logistics

Fundraising associate building major-donor relationships and grant pipelines for Parity Homes. Supporting the CEO in securing transformational funding for equitable community development.

🕒 October 2

Shockbyte

51 - 200

🎮 Gaming

☁️ SaaS

Support Associate helping Shockbyte players and server owners resolve game server, billing, cancellation, and technical issues. Supporting Shockbyte’s global multiplayer game-server hosting community.