Project Manager II (Biometrics)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Project Manager II (Biometrics): Managing Biometric deliverables including data management, biostatistics, and statistical programming for pharmaceutical and biotech clients with an accent on budget development, financial KPIs, and project timelines. Focus on executing day-to-day program activities, managing risk, and ensuring regulatory compliance with ICH, 21CFR Part 11, and ISO standards.
Location: Remotely based within South Africa
Company
is a data-focused CRO supporting the pharmaceutical, biotech, and medical device industries with a scientific approach to complex trial data and regulatory submission challenges.
What you will do
- Develop budgets and manage financial KPIs, including on-time invoicing and revenue projections.
- Create and manage moderate complexity project timelines using MSP, identifying critical path milestones.
- Execute daily project activities, including risk identification, issue escalation, and resolution.
- Strengthen client relationships and implement account growth plans to achieve annual revenue targets.
- Lead RFIs/RFPs and bid defenses in collaboration with the proposals team.
- Ensure adherence to general requirements including ICH, 21CFR Part 11, and ISO 9001:2000.
Requirements
- Must be remotely based within South Africa.
- Bachelor’s Degree or equivalent relevant work experience.
- Minimum of 5 years’ experience in project coordination or project management.
- Expert knowledge of scientific principles and concepts.
- Proficiency with MS Office, specifically intermediate Excel skills (Vlookup, Pivot Tables, etc.).
- Familiarity with 21 CFR Part 11, FDA, GCP, and ISO 9001/27001 standards.
Nice to have
- Hands-on experience with clinical trials and pharmaceutical development.
- Basic understanding of CRO operations and scientific/clinical data terminology.
Culture & Benefits
- Opportunity to work within a global footprint across four continents with a diverse talent pool.
- Environment fostering enthusiasm, collaboration, and teamwork.
- Commitment to continual training to strengthen core skills.
- Mission-driven work focused on developing life-changing therapies.
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