Astellas Pharma Inc. is a globally recognized pharmaceutical company operating in over 70 countries. Committed to transforming innovative science into life-changing therapies, Astellas focuses on unmet medical needs while upholding ethics, integrity, and patient-centric values.
📍 Location: Bangalore, India
Detailed Job Description
Job Title: Clinical Trial Specialist
📍 Location: Bangalore, India
📌 Department: Clinical Operations
📅 Job Type: Full-time
Purpose & Scope
The Clinical Trial Specialist will support the Clinical Trial Lead/Manager in the setup, execution, and close-out of clinical trials. This includes:
- Interventional drug trials (pre/post-POC)
- Clinical Pharmacology studies (healthy volunteers)
- Post-marketing regulatory trials (interventional & non-interventional)
Key Responsibilities
✔ Trial Operations Support – Assist in day-to-day trial activities, ensuring compliance with GCP/ICH guidelines.
✔ Trial Documentation – Maintain accurate trial tracking systems and TMF (Trial Master File).
✔ Site & Vendor Coordination – Support site feasibility, CRO/vendor management, and investigator training.
✔ Data Management – Assist in data cleaning, reviews, and regulatory compliance.
✔ Cross-functional Collaboration – Work with internal teams and external partners for seamless trial execution.
Eligibility & Qualifications
Required:
- BA/BS degree (or Associate’s degree + 2+ years in healthcare).
- Knowledge of ICH/GCP guidelines and clinical trial processes.
- Strong communication & administrative skills (fluent in English).
- Minimal travel (0-5%).
Preferred:
- Advanced degree (Pharma/Clinical Research).
- Prior experience in clinical trial coordination or CRO management.
Benefits & Work Culture
✅ Work-life balance with a flexible, inclusive environment.
✅ Opportunities for career growth in a global pharma leader.
✅ Ethical, patient-focused workplace culture.
