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विवरण
- Support daily clinical study operations and inspection readiness under FSP management, following established protocols and coordinating with FSP CTA Managers.
- Work with Clinical Operations and Study Managers, study teams, and CROs to deliver activities under the clinical trial operating model.
- Handle departmental tasks as needed.
- Review essential document packets, study plans, informed consent forms, and other study documentation.
- Support and oversee risk-based monitoring.
- Attend key team meetings and prepare minutes for selected studies.
- Prepare for regulatory inspections, including compiling SOP lists and storyboards.
- Support CTMS and TMF systems and related activities for selected studies.
- Assist with vendor contract administration as required.
- Support study close-out, including financial reconciliation.
- Take on additional ad hoc activities as agreed with managers.
- Coordinate with internal departments, CROs, and external vendors.
आवश्यकताएँ
- Bachelor’s degree in a scientific or healthcare-related field, or an equivalent international degree.
- 1–2 years of experience in the pharmaceutical industry, a CRO, or a related role.
- Experience with Phase 2 and 3 trials and global or international studies is an advantage.
- Experience using Veeva is required.
- Experience across multiple therapeutic areas, including oncology, is an advantage.
- Knowledge of global or regional regulatory and compliance requirements for clinical research.
- Strong task management and cross-functional collaboration skills.
- Excellent communication skills.
- Strong teamwork, organization, interpersonal, and problem-solving skills.
- Fluent business English, written and spoken.
- Able to collaborate in a fast-paced environment with attention to detail.
- Willingness to travel as required, approximately 10%.
- Must have the legal right to work in the country where the role is based.
लाभ
- Competitive base salary and performance-related incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life assurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Learning and development through structured training and career pathways.
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