Senior Clinical Data Associate

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Assist in global clinical research initiatives encompassing Phase I-IV clinical trials

• Take the lead on smaller clinical studies or co-lead larger trials with moderate oversight

• Support various clinical studies while maintaining high standards for data quality and timely delivery

• Oversee and track data management tasks conducted by CROs and external partners

• Assess study protocols and determine data capture needs, including the design of electronic case report forms (eCRF)

• Work in conjunction with CRAs, programmers, study managers, and statisticians to create annotated eCRFs and guidelines for CRF completion

• Formulate specifications for data edit checks and generate listings for study data

• Coordinate the design, testing, and resolution of issues related to Electronic Data Capture systems

• Create and uphold study Data Management Plans along with necessary documentation

• Conduct query management, reconcile external data, and manage Serious Adverse Event reconciliation tasks

• Provide support for database upgrades, migrations, user acceptance testing, and activities related to database freezes and locks

• Maintain study workbooks and data management documentation while ensuring readiness for inspections

• Contribute to the development of data management standard operating procedures (SOPs), work instructions, and process documentation

• Collaborate with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams

⛳️ Requirements

• Bachelor’s Degree in a scientific or healthcare-related discipline

• Minimum of five years’ experience in Data Management within the pharmaceutical or biotechnology sectors

• Experience in clinical research and regulated environments in pharmaceuticals or biotechnology

• Familiarity with Phase I-IV clinical trials

• Proven ability to execute core Data Management activities and engage with vendors

• Knowledge of ICH/FDA guidelines, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and relevant industry standards

• Experience with Electronic Data Capture systems and clinical data management technologies

• Strong experience with RAVE is preferred

• Excellent attention to detail, analytical skills, and organizational abilities

• Capability to collaborate effectively across multidisciplinary teams and with external partners and vendors

• Patient-centered approach with a commitment to data quality and regulatory compliance

• Comfort in working with Electronic Data Capture systems, clinical databases, and various technology platforms

• Strong communication, organizational, technical, and problem-solving abilities

• Experience in Oncology or CNS therapeutic fields is preferred

• Experience supporting Phase III pivotal studies is preferred

🏝️ Benefits

• Contribution to Medical Aid

• Gap Cover

• Life Assurance

• Provident Fund (8%)

• 13th Cheque

• Flexible remote work arrangements

• Opportunity to enhance expertise in data management processes, clinical technologies, and cross-functional study operations