Senior Clinical Data Manager – FSP

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

📋 Description

• Lead significant clinical studies or a series of interconnected studies with minimal supervision.

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

• Oversee and monitor data management tasks carried out by CROs and external vendors, while fostering effective working relationships.

• Review clinical protocols and provide leadership on data capture strategies, eCRF design, and data collection requirements.

• Collaborate with CRAs, programmers, study managers, statisticians, and other stakeholders to develop 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 and address any system-related issues.

• Review and provide insights on study documentation, including monitoring plans, statistical analysis plans, and vendor specifications.

• Conduct data reconciliations, including Serious Adverse Event reconciliation and external data source reconciliation activities.

• Lead database upgrades, migrations, user acceptance testing, database freeze activities, and database locks in accordance with company protocols.

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

• Mentor and train data management team members while contributing to the development of SOPs, work instructions, and process enhancements.

• Participate in team meetings and share expertise that supports 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 environment, including study lead responsibilities.

• 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.

• Exceptional project management, organizational, communication, problem-solving, and multitasking abilities.

• Proven capability 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.

• Strong proficiency in written and verbal communication in English.

• Expertise in clinical data management, project leadership, vendor oversight, and cross-functional collaboration.

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

• Ability to manage multiple priorities while maintaining excellent attention to detail and data quality.

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

• Commitment to delivering high-quality clinical data that supports informed decision-making and enhances patient care.

• Preferred: Background in a scientific or healthcare-related field.

• Preferred: Experience in Oncology or CNS therapeutic areas.

• Preferred: Experience supporting Phase III pivotal clinical studies.

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

🏝️ Benefits

• Medical Aid Contribution.

• Gap Cover.

• Life Assurance.

• Provident Fund (8%).

• 13th Cheque.

• Permanent, full-time employment.

• Home-based/remote work option.

• Opportunities for professional growth and leadership development.

• Chances to engage in global studies and collaborate with experienced clinical development professionals.