Senior Clinical Data Manager - South Africa (Home-based) - FSP at PAREXEL

About the Role

We are seeking a Senior Clinical Data Manager to join our team in South Africa in a permanent, full-time capacity.

• As a Senior Clinical Data Manager, you will play a critical role in supporting global commercial and development programs by leading clinical data management activities across Phase 1-4 studies. This position is central to ensuring the quality, integrity, and reliability of clinical trial data that support the development of innovative therapies for patients worldwide.
• You will serve as a key data management leader within cross-functional study teams, driving the planning, execution, and oversight of data management deliverables throughout the clinical trial lifecycle. Responsibilities include leading study-level data management activities, collaborating with internal stakeholders and external vendors, supporting electronic data capture system development and validation, overseeing database lock activities, and ensuring compliance with regulatory requirements and industry standards.
• You'll join a fast-paced, growth-oriented environment where your expertise will directly influence study outcomes, operational excellence, and the successful delivery of clinical research programs.
• With opportunities to work across global studies and collaborate with experienced clinical development professionals, this role offers a meaningful path for continued professional growth and leadership within clinical data management.

Key Responsibilities

• 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 while building effective working relationships
• 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 in accordance with company procedures
• Maintain study workbooks, data management files, and study documentation
• Mentor and train data management team members while contributing to the development of SOPs, work instructions, and process improvements
• Participate in team meetings and contribute expertise that supports study and organizational objectives

Candidate Profile

You’ll thrive in this role if you bring:

• Strengths in clinical data management, project leadership, vendor oversight, and cross-functional collaboration
• Experience working within pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments
• The ability to manage multiple priorities while maintaining exceptional attention to detail and data quality
• Strong communication skills and the confidence to collaborate effectively across internal teams and external partners
• Comfort working with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation processes
• A commitment to delivering high-quality clinical data that supports informed decision-making and advances patient care

Required Qualifications

• 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

Preferred Qualifications

• Scientific or healthcare-related educational background
• Experience within Oncology or CNS therapeutic areas
• Experience supporting Phase III pivotal clinical studies
• Experience training internal and external study team members on EDC systems and data management procedures

Benefits and Compensation

• Medical Aid Contribution
• Gap Cover
• Life Assurance
• Provident Fund (8%)
• 13th Cheque