Senior Clinical Data Manager – FSP

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

📋 Description

• Lead large-scale clinical studies or a sequence of related studies with minimal supervision.

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

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

• Evaluate clinical protocols and provide strategic direction on data capture methods, eCRF design, and data collection needs.

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

• Spearhead the formulation of data edit check specifications, data listings, and study-level data management plans.

• Coordinate the design, testing, and execution of Electronic Data Capture systems and address system-related challenges.

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

• Execute data reconciliations, including Serious Adverse Event reconciliation and external data source reconciliation tasks.

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

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

• Mentor and train members of the data management team.

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

• Engage in team meetings and provide expertise to support study and organizational goals.

⛳️ Requirements

• BA/BS degree, preferably 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 experience as a study lead.

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

• Experience with 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 processes.

• Excellent English written and verbal communication skills.

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

• Ability to manage multiple priorities while ensuring exceptional attention to detail and data quality.

• Comfort working 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

• Flexibility

• Professional growth opportunities

• Opportunities to collaborate on global studies

• Partnership with experienced clinical development professionals