Senior Clinical Data Manager – FSP

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

📋 Description

• Lead extensive clinical studies or a series of interconnected studies with minimal oversight.

• Represent Data Management in cross-functional clinical trial working groups for designated studies.

• Supervise and monitor data management tasks conducted by CROs and external vendors.

• Review clinical protocols and provide guidance on data capture strategies, eCRF design, and data collection prerequisites.

• Collaborate with CRAs, programmers, study managers, statisticians, and other stakeholders to create annotated eCRFs and completion guidelines.

• Direct the development of data edit check specifications, data listings, and comprehensive study-level data management plans.

• Coordinate the design, testing, and implementation of Electronic Data Capture systems while addressing system-related challenges.

• Review and offer feedback on study documentation, including monitoring plans, statistical analysis plans, and vendor specifications.

• Conduct data reconciliations, including those for Serious Adverse Events and external data sources.

• Lead database upgrades, migrations, user acceptance testing, database freeze activities, and database locks.

• Maintain study workbooks, data management files, and documentation related to the study.

• Mentor and train members of the data management team.

• Contribute to the development of SOPs, work instructions, and process enhancements.

• Participate in team meetings and share expertise to support study and organizational goals.

⛳️ Requirements

• BA/BS degree, ideally in a scientific or healthcare-related discipline.

• A minimum of seven years of experience in Data Management within the pharmaceutical or biotechnology sector, or equivalent experience in an FDA-regulated setting, including study lead roles.

• Familiarity with ICH-GCP, FDA guidelines, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and clinical trial methodologies.

• Proficient in Electronic Data Capture systems and clinical data management technologies.

• Strong skills in project management, organization, communication, problem-solving, and multitasking.

• Demonstrated ability to support Phase 1-4 clinical studies and collaborate effectively with vendors and cross-functional teams.

• Knowledge of database upgrades, migrations, user acceptance testing, and advanced data management practices.

• Excellent written and verbal communication skills in English.

• Experience in pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments.

• Proficiencies in clinical data management, project leadership, vendor oversight, and cross-functional teamwork.

• Capacity to handle multiple priorities while ensuring exceptional attention to detail and data quality.

• Comfort with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation processes.

• Preferred: experience in Oncology or CNS therapeutic areas.

• Preferred: experience in supporting Phase III pivotal clinical studies.

• Preferred: experience in training internal and external study team members on EDC systems and data management protocols.

🏝️ Benefits

• Medical Aid Contribution.

• Gap Cover.

• Life Assurance.

• Provident Fund (8%).

• 13th Cheque.

• Permanent, full-time position.

• Home-based/remote work arrangement.

• Opportunities for ongoing professional development and leadership within clinical data management.