Senior Clinical Data Manager – FSP

• Lead large clinical studies or a series of related studies with minimal guidance
• Represent Data Management on cross-functional clinical trial working groups for assigned studies
• Oversee and monitor data management activities performed by CROs and external vendors
• Review clinical protocols and provide leadership on data capture strategy, eCRF design, and data collection requirements
• Collaborate with CRAs, programmers, study managers, statisticians, and other stakeholders to develop annotated eCRFs and completion guidelines
• Lead the development of data edit check specifications, data listings, and study-level data management plans
• Coordinate the design, testing, and implementation of Electronic Data Capture systems and resolve system-related issues
• Review and provide feedback 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
• Maintain study workbooks, data management files, and study documentation
• Mentor and train data management team members
• Contribute to the development of SOPs, work instructions, and process improvements
• Participate in team meetings and contribute expertise supporting study and organizational objectives

• BA/BS degree, preferably in a scientific or healthcare-related field
• At least seven years of experience in Data Management within the pharmaceutical or biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience
• Knowledge of ICH-GCP, FDA guidance, 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 project management, organization, communication, problem-solving, and multitasking skills
• Proven ability to support Phase 1-4 clinical studies and work effectively with vendors and cross-functional teams
• Familiarity with database upgrades, migrations, user acceptance testing, and advanced data management processes
• Strong English written and verbal communication skills
• Experience working within pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments
• Ability to manage multiple priorities while maintaining 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 within Oncology or CNS therapeutic areas
• Preferred: Experience supporting Phase III pivotal clinical studies
• Preferred: Experience training internal and external study team members on EDC systems and data management procedures

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque
• Flexibility
• Professional growth opportunities
• Opportunities to work across global studies
• Collaboration with experienced clinical development professionals