Clinical Trial Specialist

Why This Role Matters
Clinical Trial Specialists play a pivotal role in ensuring the successful execution of clinical trials that bring innovative therapies to patients. By supporting operational excellence, regulatory compliance, and high-quality trial documentation, this role contributes directly to advancing drug development and addressing unmet medical needs globally.

Job Description
Astellas Pharma is hiring a Clinical Trial Specialist for its Bengaluru location under a hybrid work model. The role supports Clinical Trial Leads and Clinical Trial Managers in day-to-day trial operations, including trial set-up, execution, documentation, and close-out activities. The position spans pre/post-POC interventional trials, clinical pharmacology trials, post-marketing commitments, and regulatory studies, ensuring compliance with ICH/GCP and company SOPs.

Key Features of the Role:
• Full-time hybrid role (Bengaluru)
• Exposure to global cross-functional clinical teams
• Involvement in interventional and non-interventional trials
• Participation in TMF management and vendor coordination
• Minimal travel (0–5%)
• Opportunity within Astellas Global Capability Centre (GCC)

Responsibilities
• Support day-to-day clinical trial operations
• Assist in trial set-up, execution, and close-out processes
• Ensure compliance with ICH/GCP guidelines and regulatory standards
• Maintain accurate trial tracking and documentation systems
• Participate in CRO and vendor coordination
• Support TMF set-up and quality maintenance
• Assist in site feasibility assessments
• Coordinate investigator and site monitor training
• Contribute to data cleaning and review processes
• Implement patient-focused strategies during trial execution

Required Qualifications
• BA/BS degree
• Minimum 2 years of clinical trial experience
• Strong communication and interpersonal skills
• Proficiency in administrative and computer systems
• Fluency in English (written and oral)

Educational Requirements:
• Bachelor’s degree in Life Sciences or related field
• Advanced degree preferred

Experience and Skills:
• Knowledge of clinical protocol and drug development processes
• Familiarity with clinical trial phases
• Understanding of ICH/GCP guidelines
• Strong documentation and organizational skills
• Ability to collaborate across global teams
• High attention to detail and quality compliance focus

Age Eligibility:
As per company norms

Salary Insights
Salary not disclosed. Compensation will align with industry standards and Astellas internal policies.

Company Overview
Astellas Pharma Inc. operates in over 70 countries worldwide and is committed to transforming innovative science into value-driven medical solutions. Through its Global Capability Centres in India, Poland, and Mexico, Astellas enhances operational efficiency, innovation, and resilience while maintaining high ethical standards and patient-focused development strategies.

FAQs

Is prior clinical trial experience required?
Yes, a minimum of 2 years of clinical trial experience is required.

Is this a remote role?
It follows a hybrid work model based in Bengaluru.

Is travel required?
Minimal travel (0–5%) may be required.

Is knowledge of ICH/GCP necessary?
Yes, general knowledge of ICH/GCP guidelines is preferred.

How can candidates apply?
Apply through the official Astellas LinkedIn listing or company portal.

Application Tips
• Highlight clinical trial coordination experience clearly
• Mention exposure to TMF and vendor management
• Demonstrate knowledge of ICH/GCP compliance
• Showcase teamwork and cross-functional collaboration skills
• Ensure resume reflects operational and documentation expertise