Senior Clinical Data Analyst – South Africa, Poland, Hungary, UK

3 days ago

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Lead a large clinical study or a series of related studies with minimum guidance. • Represents Data Management on the CTWG for assigned studies. • Provide mentoring and training to lower-level Data Management staff assigned to your studies. • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts. • Review 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. • Lead the development of data edit check specifications and data listings. • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. • Able to resolve EDC system issues with team members. • Develop or lead the development of 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 specifications. • Provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed. • Perform reconciliation of header data from external data sources against the clinical database. • Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines. • Lead database upgrades/migrations including performing User Acceptance Testing. • Maintain study workbooks and data management files. • Perform database lock and freeze activities per company SOPs. • Participate in regular team meetings and provide input when appropriate. • Provide input into the development of data management SOPs, Work Instructions, and process documents; take a leadership role in the development of assigned documents. • Contribute to a professional working environment including the application of the sponsor’s Code of Business Conduct and Ethics. • Assist with the training of new employees and/or contractors.

🎯 Requirements

• Bachelor’s Degree required, preferably in the scientific/healthcare field. • Proven leadership experience. • Good project management skills and a proven ability to multitask. • At least five years’ or preferably up to 8 years' experience, in Data Management for the pharmaceutical/biotechnology industry. • Understanding of the scope and focus of Phase I – IV clinical studies, and a proven ability to perform some of the core Data Management tasks and interact with vendors. • A comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. • Strong English language written and verbal communication skills. • Able to travel to meetings or training seminars on occasion. • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. • Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable. • Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.

🏖️ Benefits

• Flexible working hours • Professional development opportunities • Remote work options