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Parexel yangi dori vositalarini ishlab chiqish jarayonida biofarmatsevtika kompaniyalariga xizmat ko‘rsatuvchi global klinik tadqiqot tashkilotidir. Uning faoliyati I–IV bosqich klinik sinovlari, portfel va tadqiqotlarni boshqarish, tartibga solish strategiyasi, bozorga chiqish hamda hayotiy siklni rejalashtirishni qamrab oladi. 21 000 dan ortiq mutaxassisga ega Parexel klinik, tartibga solish va terapevtik tajribani bemorlar haqidagi tushunchalar hamda innovatsion sinov dizaynlari bilan birlashtiradi. Kompaniya onkologiya, neyrofanlar va kam uchraydigan kasalliklar kabi yo‘nalishlarda tadqiqotlarni qo‘llab-quvvatlaydi hamda klinik ishlab chiqish jarayonini samaraliroq va bemorga yo‘naltirilgan qilishga e’tibor qaratadi.
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.
Tavsif
- 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
Talablar
- 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
Imtiyozlar
- 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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