Senior Clinical Data Associate

Parexel

. Support global clinical research programs across Phase I-IV clinical studies .

Posted 10/30/2026full-timeRemote • South AfricaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Data Management for clinical research, including proficiency in Electronic Data Capture systems and adherence to regulatory standards such as ICH/FDA guidance and CDISC. Capable of leading clinical studies while ensuring data quality and compliance across multidisciplinary teams.

Highest-signal resume keywords

Data Management ExperienceElectronic Data Capture SystemsICH/FDA Guidance KnowledgeStrong RAVE ExperienceCollaboration Across Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Management ActivitiesECRF DesignData Edit Check SpecificationsQuery ManagementExternal Data ReconciliationDatabase Lock ActivitiesStudy Data ListingsData Management PlansRegulatory ComplianceClinical Study Protocol Review

Soft Skills

Attention to DetailAnalytical ThinkingOrganizational SkillsStrong CommunicationProblem-Solving Skills

Tools & Technologies

Electronic Data Capture SystemsClinical DatabasesRAVEData Management TechnologiesStudy Management Tools

Industry Keywords

Phase I-IV Clinical StudiesPharmaceutical IndustryBiotechnology IndustryGCDMP21 CFR Part 11MedDRAWHO Drug DictionariesOncology Therapeutic AreaCNS Therapeutic AreaPhase III Pivotal Studies

About the role

Key responsibilities & impact

Support global clinical research programs across Phase I-IV clinical studies
Lead a small clinical study or co-lead larger studies with moderate guidance
Support multiple clinical studies while ensuring high standards of data quality and delivery
Manage and monitor data management activities performed by CROs and external vendors
Review study protocols and evaluate data capture requirements, including eCRF design
Collaborate with CRAs, programmers, study managers, and statisticians to develop annotated eCRFs and CRF completion guidelines
Develop data edit check specifications and generate study data listings
Coordinate the design, testing, and issue resolution of Electronic Data Capture systems
Develop and maintain study Data Management Plans and supporting documentation
Perform query management, external data reconciliations, and Serious Adverse Event reconciliation activities
Support database upgrades, migrations, user acceptance testing, database freeze activities, and database lock activities
Maintain study workbooks and data management files while ensuring inspection readiness
Contribute to data management SOPs, work instructions, and process documentation
Collaborate with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams

Requirements

What you’ll need

Bachelor's Degree in a scientific or healthcare-related field
At least five years' experience in Data Management within the pharmaceutical or biotechnology industry
Experience working within clinical research and regulated pharmaceutical or biotechnology environments
Understanding of Phase I-IV clinical studies
Demonstrated ability to perform core Data Management activities and work with vendors
Knowledge of ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and related industry standards
Experience with Electronic Data Capture systems and clinical data management technologies
Strong RAVE experience is preferred
Strong attention to detail, analytical thinking, and organizational skills
Ability to collaborate effectively across multidisciplinary teams and with external partners and vendors
Patient-focused mindset with commitment to data quality and regulatory compliance
Comfort working with Electronic Data Capture systems, clinical databases, and multiple technology platforms
Strong communication, organization, technical, and problem-solving skills
Experience in Oncology or CNS therapeutic areas is preferred
Experience supporting Phase III pivotal studies is preferred

Benefits

Comp & perks

Medical Aid Contribution
Gap Cover
Life Assurance
Provident Fund (8%)
13th Cheque
Remote work arrangement
Opportunity to expand expertise across data management processes, clinical technologies, and cross-functional study operations