Clinical Trial Specialist (ClinOps/TMF) at Astellas, Bengaluru
Astellas has opened doors for experienced professionals looking to advance in clinical research and clinical trial operations with the position of Clinical Trial Specialist in Bengaluru, India. This role involves supporting Clinical Trial Leads and Clinical Trial Managers in the management of clinical trials, ensuring compliance with regulatory standards.
About Astellas
Astellas is a global pharmaceutical company dedicated to improving the health of people around the world through innovative and reliable pharmaceutical products. Headquartered in Japan, Astellas operates in various therapeutic areas, including oncology, urology, and immunology, and is committed to addressing significant unmet medical needs through research and development.
Company: Astellas
Position: Clinical Trial Specialist
Location: Bengaluru, India
Department: Clinical Operations
Work Model: Hybrid
Qualification: BA/BS or Advanced Degree
Experience: 3+ years with BA/BS or 2+ years with MS/PhD/PharmD
Travel: Approximately 25%
Language: Fluent English
Key Area: Clinical Trial Operations
Estimated Salary: ₹10,00,000 – ₹18,00,000 per year*
*Salary is an editorial estimate for similar clinical research roles in Bengaluru and is not an employer-disclosed salary. Actual compensation may vary based on experience, qualifications, responsibilities, and Astellas compensation policies.
Clinical Trial Specialist Job Description
The Clinical Trial Specialist at Astellas supports the operational delivery of assigned drug trials throughout the clinical trial lifecycle. This role involves working closely with global cross-functional teams, CROs, investigative sites, and external vendors to ensure clinical studies are established and executed efficiently.
Key Responsibilities
- Support day-to-day clinical trial operations and ensure assigned activities are completed according to project objectives, milestones, and deliverables.
- Ensure trial activities comply with applicable ICH-GCP guidelines, regulatory requirements, SOPs, and established standards.
- Collaborate with Clinical Trial Specialist team members and global stakeholders to maintain accurate and current clinical trial information.
- Participate in the development of clinical trial plans and operational systems.
- Support trial system set-up and implementation of appropriate processes and standards.
- Help ensure quality across investigative sites, clinical trial vendors, and trial data.
- Participate in clinical trial site feasibility assessments and maintain associated feasibility information.
- Support CRO and vendor set-up and management during clinical trial execution.
Eligibility Criteria
According to the Astellas job description, candidates should meet one of the following experience and education combinations:
- Option 1: BA/BS degree or relevant equivalent qualification with at least 3 years of clinical trial experience.
- Option 2: Candidates with an advanced degree such as MS, PhD, or PharmD should have at least 2 years of clinical trial experience.
Required Skills
- Strong knowledge of ICH-GCP Guidelines
- Clinical Trial Operations
- Clinical Research
- Clinical Drug Development
- Clinical Trial Design
- Project Management
- Stakeholder Management
- Written and Verbal Communication
How to Apply
Interested candidates can apply through the following link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Why Join Astellas?
Astellas offers a collaborative environment where employees can work with global life science professionals. The organization emphasizes career development, innovation, and making a significant impact on patient health through the development of therapies for unmet medical needs.
Conclusion
The opportunity at Astellas for the Clinical Trial Specialist position presents a chance for qualified candidates to contribute to meaningful clinical research initiatives. Interested individuals are encouraged to apply before the deadline to be considered for this impactful role.
