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.
Senior Clinical Data Manager, FSP – Parexel (Remote, South Africa)
Lead clinical data management for Parexel’s global Phase 1–4 trials, coordinating EDC systems, vendors, reconciliations, database locks, and regulatory-quality data.
Descriere
- Direct large clinical studies or related study programs with limited supervision
- Represent Data Management in cross-functional clinical trial working groups
- Oversee clinical data management work completed by CROs and external vendors
- Evaluate 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
- Lead the creation of edit check specifications, data listings, and study-specific data management plans
- Coordinate EDC system design, testing, implementation, and issue resolution
- Review study documents such as monitoring plans, statistical analysis plans, and vendor specifications, providing informed feedback
- Perform data reconciliations, including Serious Adverse Event and external data source reviews
- Lead database upgrades, migrations, user acceptance testing, freezes, and locks
- Keep study workbooks, data management files, and related documentation current
- Coach and develop members of the data management team
- Support SOPs, work instructions, and continuous process improvements
- Join team meetings and apply subject-matter expertise to study and organizational priorities
Cerințe
- Bachelor’s degree in a scientific or healthcare-related discipline is preferred
- At least five years of pharmaceutical or biotechnology data management experience, or comparable 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 EDC platforms and clinical data management technologies
- Strong project management, organizational, communication, problem-solving, and multitasking capabilities
- 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
- Experience in pharmaceutical, biotechnology, clinical research, or another FDA-regulated setting
- Ability to balance competing priorities while maintaining exceptional attention to detail and data quality
- Confidence working with EDC platforms, clinical databases, data management tools, and study documentation workflows
Beneficii
- Medical aid contribution
- Gap cover
- Life assurance
- Provident fund contribution of 8%
- 13th cheque
- Permanent full-time employment
- Home-based work arrangement
- Ongoing professional development and leadership opportunities in clinical data management