Clinical Data Associate II – FSP

Parexel

. Lead a small clinical study or co-lead larger studies with moderate guidance .

Posted 10/30/2026full-timeRemote • South AfricaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Data Management within clinical studies, including proficiency in Electronic Data Capture systems and adherence to industry standards such as ICH/FDA guidance and CDISC. Capable of collaborating across multidisciplinary teams to ensure high-quality data delivery and compliance in regulated environments.

Highest-signal resume keywords

Data Management ExperienceElectronic Data Capture SystemsICH/FDA Guidance KnowledgeCollaboration Across TeamsRAVE Experience

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 PlansSerious Adverse Event ReconciliationClinical Study Protocol Review

Soft Skills

Strong Communication SkillsOrganizational SkillsProblem-Solving Skills

Tools & Technologies

Electronic Data Capture SystemsClinical Data Management Technologies

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

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 the development and improvement of data management SOPs, work instructions, and process documentation
Partner with clinical teams, statisticians, programmers, CRAs, vendors, and study management teams to ensure accurate and timely data activities

Requirements

What you’ll need

Bachelor's Degree in a scientific or healthcare-related field
At least two years' experience in Data Management within the pharmaceutical or biotechnology industry
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 communication, organization, technical, and problem-solving skills
Experience working within clinical research and regulated pharmaceutical or biotechnology environments
Ability to collaborate effectively across multidisciplinary teams and with external partners and vendors
Experience in Oncology or CNS therapeutic areas preferred
Experience supporting Phase III pivotal studies preferred
RAVE experience strongly preferred

Benefits

Comp & perks

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