Senior Clinical Data Manager – FSP

Parexel

. Lead large clinical studies or a series of related studies with minimal guidance .

Posted 10/7/2026full-timeRemote • South AfricaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading clinical data management activities, including oversight of CROs, development of data management plans, and implementation of Electronic Data Capture systems. Proven ability to collaborate with cross-functional teams and ensure compliance with regulatory standards in the pharmaceutical and biotechnology industries.

Highest-signal resume keywords

Data Management LeadershipElectronic Data Capture SystemsICH-GCP ComplianceProject Management SkillsClinical Trial Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ReconciliationECRF DesignDatabase UpgradesData Listings DevelopmentStatistical Analysis Plans ReviewSOP DevelopmentData Quality ManagementStudy Documentation ProcessesAdvanced Data Management ProcessesClinical Data Management Technologies

Soft Skills

Communication SkillsProblem-Solving SkillsMultitasking SkillsOrganizational SkillsMentoring Skills

Tools & Technologies

Electronic Data Capture SystemsClinical DatabasesData Management Software

Industry Keywords

FDA-Regulated EnvironmentPharmaceutical IndustryBiotechnology IndustryClinical ResearchOncology Therapeutic AreaCNS Therapeutic AreaCDISC StandardsGCDMP21 CFR Part 11MedDRA

About the role

Key responsibilities & impact

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
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
Maintain study workbooks, data management files, and study documentation
Mentor and train data management team members
Contribute to the development of SOPs, work instructions, and process improvements
Participate in team meetings and contribute expertise supporting study and organizational objectives

Requirements

What you’ll need

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
Experience working within pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments
Ability to manage multiple priorities while maintaining exceptional attention to detail and data quality
Comfort working with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation processes
Preferred: Experience within Oncology or CNS therapeutic areas
Preferred: Experience supporting Phase III pivotal clinical studies
Preferred: Experience training internal and external study team members on EDC systems and data management procedures

Benefits

Comp & perks

Medical Aid Contribution
Gap Cover
Life Assurance
Provident Fund (8%)
13th Cheque
Flexibility
Professional growth opportunities
Opportunities to work across global studies
Collaboration with experienced clinical development professionals