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Parexel
Parexel
H1B Visa SponsorConsultingHealthcareLogistics
Parexel is a global clinical research organization serving biopharmaceutical companies throughout the development of new medicines. Its work spans Phase I–IV clinical trials, portfolio and trial management, regulatory strategy, market access, and lifecycle planning. With more than 21,000 professionals, Parexel combines clinical, regulatory, and therapeutic expertise with patient insights and innovative trial designs. The company supports research across areas including oncology, neuroscience, and rare diseases, with a focus on making clinical development more efficient and patient-centered.
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Senior Clinical Data Manager – FSP (Remote, South Africa)

Lead clinical data management for Parexel’s global pharmaceutical and biotechnology trials. Manage EDC systems, vendors, reconciliations, and database locks across Phase 1–4 studies.

ZASouth AfricaRemoteFull-timeSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Lead major clinical studies or related study programs with limited supervision
  • Represent Data Management in cross-functional clinical trial working groups
  • Oversee clinical data management activities delivered by CROs and external vendors
  • Review protocols and guide data capture strategy, eCRF design, and collection requirements
  • Partner with CRAs, programmers, study managers, statisticians, and other stakeholders on annotated eCRFs and completion guidelines
  • Direct the creation of edit check specifications, data listings, and study-level data management plans
  • Coordinate EDC system design, testing, implementation, and issue resolution
  • Review and advise on monitoring plans, statistical analysis plans, vendor specifications, and related study documents
  • Perform SAE and external data source reconciliations
  • Lead database upgrades, migrations, user acceptance testing, freezes, and locks
  • Maintain study workbooks, data management files, and essential documentation
  • Mentor and train members of the data management team
  • Help develop SOPs, work instructions, and process improvements
  • Participate in team meetings and provide expertise aligned with study and organizational goals

Requirements

  • Bachelor’s degree, preferably in a scientific or healthcare discipline
  • Seven or more years of pharmaceutical or biotechnology data management experience, or equivalent FDA-regulated experience, including study leadership
  • Working knowledge of ICH-GCP, FDA guidance, CDISC, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and clinical trial operations
  • Experience using EDC platforms and clinical data management technologies
  • Strong project management, organizational, communication, problem-solving, and multitasking abilities
  • Demonstrated ability to support Phase 1–4 studies and collaborate effectively with vendors and cross-functional teams
  • Familiarity with database upgrades, migrations, user acceptance testing, and advanced data management workflows
  • Strong written and spoken English communication skills
  • Background in pharmaceutical, biotechnology, clinical research, or another FDA-regulated setting
  • Ability to balance competing priorities while protecting data quality and attention to detail
  • Comfort working with EDC platforms, data management tools, clinical databases, and study documentation
  • Oncology or CNS therapeutic experience preferred
  • Experience supporting pivotal Phase III studies preferred
  • Experience training internal and external study teams on EDC platforms and data management procedures preferred

Benefits

  • Medical aid contribution
  • Gap cover
  • Life assurance
  • Provident fund contribution of 8%
  • 13th cheque
  • Flexible working arrangements
  • Professional development opportunities
  • Exposure to global clinical studies
  • Collaboration with experienced clinical development professionals

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