Clinical Trial Specialist – Clinical Operations
Location: Bengaluru, India
Employment Type: Full-Time
Work Model: Hybrid (as per company policy)
Category: Clinical Research / Clinical Operations
Travel Requirement: Minimal (0–5%)
Role Overview
Astellas is seeking a Clinical Trial Specialist (CTS) to support the planning, execution, and close-out of global clinical trials. This role works closely with Clinical Trial Leads and Clinical Trial Managers to ensure high-quality trial delivery in compliance with ICH-GCP guidelines, regulatory requirements, SOPs, and internal standards.
The position is ideal for professionals with hands-on experience in clinical trial operations, site coordination, CRO/vendor management, and trial documentation who are looking to grow within a global pharmaceutical environment.
Key Responsibilities
Clinical Trial Operations and Execution
Support day-to-day operational activities for assigned clinical trials with a strong focus on timelines, quality, and compliance
Assist in the setup, execution, and close-out of interventional and non-interventional drug trials, including pre- and post-proof-of-concept studies, clinical pharmacology trials, pre-approval access programs, and post-marketing regulatory commitment studies
Collaborate with global cross-functional teams and vendors to ensure operational excellence across all trial phases
Trial Planning and Systems Management
Contribute to the development of trial operational plans and study-level system setup
Ensure accurate and timely maintenance of trial data in tracking systems and provide regular updates to stakeholders
Support site feasibility assessments and maintain associated data
Vendor, CRO, and Site Support
Participate in CRO and vendor setup, coordination, and management during trial execution
Support investigator site activities, including training coordination and communication
Assist in implementing patient-focused strategies to enhance trial participation and retention
Data, Documentation, and Compliance
Support Trial Master File (TMF) setup, maintenance, and quality checks to ensure inspection readiness
Participate in data cleaning activities, medical data reviews, and trial documentation management
Ensure all trial activities comply with applicable regulations, ICH-GCP guidelines, SOPs, and internal standards
Team Collaboration and Communication
Participate in trial team meetings and manage associated documentation
Maintain effective communication with internal teams, vendors, and external stakeholders
Required Qualifications and Experience
Bachelor’s degree (BA/BS) in life sciences, pharmacy, medicine, or a related healthcare field
Minimum 2 years of clinical trial experience in a healthcare, pharmaceutical, biotechnology, or CRO environment
Strong interpersonal, written, verbal, presentation, and administrative skills
Proficiency in computer applications and clinical trial systems
Fluency in written and spoken English
Working knowledge of clinical trial phases, clinical development processes, study protocols, and ICH-GCP guidelines
Preferred Qualifications
Advanced degree in life sciences, pharmacy, medicine, or a related discipline
Working Environment
Astellas supports a hybrid working model, enabling employees to balance on-site collaboration with remote work flexibility, in line with company policies and Responsible Flexibility Guidelines. This approach promotes productivity, collaboration, and work–life balance.
Equal Opportunity Statement
Astellas is an Equal Opportunity Employer and is committed to providing equal employment opportunities to all qualified individuals, including persons with disabilities and protected veterans. Employment decisions are based on merit, qualifications, and business needs.
Recruitment Fraud Notice
Candidates are advised to remain vigilant against recruitment scams. Legitimate communication from Astellas will only originate from official company email addresses or verified Astellas LinkedIn profiles.
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