[Hiring] Senior Clinical Data Manager @Parexel

Role Description

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
• 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.

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 five years (preferably seven +) 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

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