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Parexel
Parexel
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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Senior Clinical Data Manager, FSP — South Africa Remote

Lead data management for Phase 1–4 clinical trials at Parexel, overseeing EDC systems, vendors, reconciliations, and database locks. Partner with cross-functional teams to maintain high-quality clinical data and study documentation.

ZAAfrica de SudRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Lead major clinical studies or related study programs with limited supervision
  • Represent Data Management in cross-functional working groups for assigned clinical trials
  • Oversee CRO and external vendor data management activities while maintaining productive working relationships
  • Review protocols and direct data capture strategies, eCRF design, and data collection requirements
  • Work with CRAs, programmers, study managers, statisticians, and other stakeholders to create annotated eCRFs and completion guidelines
  • Direct the creation of edit check specifications, data listings, and study-specific data management plans
  • Coordinate the design, testing, and deployment of Electronic Data Capture systems and troubleshoot related issues
  • Review study documents, including monitoring plans, statistical analysis plans, and vendor specifications, and provide feedback
  • Perform data reconciliations, including Serious Adverse Event and external data source reconciliations
  • Lead database upgrades, migrations, user acceptance testing, freezes, and locks in line with company procedures
  • Keep study workbooks, data management files, and related study documentation current
  • Coach and train data management staff while helping develop SOPs, work instructions, and process improvements
  • Attend team meetings and provide expertise that advances study and organizational goals

Cerințe

  • Bachelor’s degree, preferably in a scientific or healthcare discipline
  • Seven or more years of Data Management experience in the pharmaceutical or biotechnology sector, or equivalent FDA-regulated experience, including study leadership
  • Working knowledge of ICH-GCP, FDA guidance, CDISC standards, GCDMP, 21 CFR Part 11, MedDRA, WHO Drug Dictionaries, and clinical trial processes
  • Experience using Electronic Data Capture systems 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 activities
  • Strong written and spoken English communication skills
  • Expertise in clinical data management, project leadership, vendor oversight, and cross-functional collaboration
  • Experience in pharmaceutical, biotechnology, clinical research, or other FDA-regulated environments
  • Ability to manage competing priorities while preserving exceptional attention to detail and data quality
  • Comfort working with Electronic Data Capture systems, data management technologies, clinical databases, and study documentation workflows
  • Commitment to producing high-quality clinical data for informed decision-making and improved patient care
  • Preferred: Educational background in a scientific or healthcare field
  • Preferred: Experience in Oncology or CNS therapeutic areas
  • Preferred: Experience supporting pivotal Phase III clinical studies
  • Preferred: Experience training internal and external study team members in EDC systems and data management procedures

Beneficii

  • Medical aid contribution
  • Gap cover
  • Life assurance
  • Provident fund contribution of 8%
  • 13th cheque
  • Permanent, full-time employment
  • Home-based remote work
  • Professional development and leadership opportunities
  • Work across global studies with experienced clinical development professionals

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