Senior Clinical Data Associate – FSP

Parexel

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

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Data Management within clinical research, focusing on Electronic Data Capture systems, data quality assurance, and compliance with industry standards such as ICH/FDA guidance and CDISC. Proven ability to lead clinical studies and collaborate effectively with cross-functional teams to ensure timely and accurate data delivery.

Highest-signal resume keywords

Data ManagementElectronic Data Capture SystemsICH/FDA GuidanceClinical ResearchRAVE Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Management ActivitiesStudy Protocol ReviewECRF DesignData Edit Check SpecificationsQuery ManagementExternal Data ReconciliationDatabase Lock ActivitiesStudy Data ListingsData Management PlansSerious Adverse Event Reconciliation

Soft Skills

Strong CommunicationOrganization SkillsTechnical Problem-Solving

Tools & Technologies

Electronic Data Capture SystemsClinical Data Management Technologies

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryPhase I-IV Clinical StudiesGCDMP21 CFR Part 11MedDRAWHO Drug DictionariesOncologyCNS Therapeutic AreasPhase 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 electronic Case Report Form (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 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 communication, organization, technical, and problem-solving skills
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
Flexible work arrangements
Growth opportunities
Opportunity to expand expertise across data management processes, clinical technologies, and cross-functional study operations