Clinical Trial Specialist
Location: Bengaluru, Karnataka, India
Job Type: Full-Time
Category: Clinical Operations / Medical Affairs
Company Overview
Astellas Pharma Inc. is a global pharmaceutical leader operating in over 70 countries, committed to transforming innovative science into medical solutions that deliver value and hope to patients and families. With a strong focus on unmet medical needs, ethical business practices, and scientific excellence, Astellas drives innovation in drug development to improve health outcomes worldwide.
Role Overview
We are seeking a Clinical Trial Specialist to support Clinical Trial Leads and Managers in the end-to-end management of interventional and non-interventional drug trials, including pre/post-POC studies, Clinical Pharmacology trials in healthy volunteers, pre-approval access studies, and post-marketing regulatory commitment trials. This role ensures operational excellence across trial set-up, execution, and close-out, maintaining quality, compliance, and alignment with GCP/ICH guidelines and internal SOPs.
This position reports directly to the Clinical Operations Functional Head, Manager, or Clinical Operations Lead.
Key Responsibilities
Support day-to-day clinical trial operations with a strong sense of urgency to meet project objectives, milestones, and deliverables.
Collaborate with global cross-functional team members and vendors to maintain accurate trial information in tracking systems and provide updates to trial teams and stakeholders.
Assist in trial planning, site feasibility assessments, system set-up, and implementation of quality standards across investigative sites and vendors.
Support or lead Trial Master File (TMF) set-up, maintenance, and documentation quality assurance.
Participate in coordination of CRO and vendor set-up and management, investigator/site monitor training, and patient-focused strategies for assigned trials.
Ensure compliance with GCP, ICH guidelines, SOPs, and regulatory requirements during trial execution.
Contribute to data cleaning, data reviews, and reporting to maintain high-quality trial outputs.
Required Qualifications & Experience
Bachelor’s degree (BA/BS) in a relevant healthcare or scientific discipline.
Minimum 2 years of experience in clinical trials, clinical operations, or healthcare research.
Strong understanding of clinical protocol, drug development processes, and clinical trial phases.
Excellent interpersonal, written, verbal, and presentation skills.
Proficiency in Microsoft Office and general clinical trial software/tools.
Fluent in English (oral and written).
Minimal travel required (0–5%).
Preferred Qualifications
Advanced degree (Master’s/PhD) in Life Sciences, Medicine, or related field.
Prior experience with clinical trial set-up, site monitoring, and cross-functional coordination.
Working Environment
Hybrid work model with flexibility to work from home and office in accordance with Astellas’ Responsible Flexibility Guidelines.
Opportunity to collaborate with Astellas’ Global Capability Centres (GCCs) in India, enhancing operational efficiency, resilience, and innovation potential.
Engaging and inclusive environment that values diversity, professional development, and work-life balance.
Why Join Astellas Pharma?
Be part of a global team delivering innovative therapies and making a meaningful impact on patients’ lives.
Collaborate with experts across clinical operations, regulatory, and medical affairs functions.
Access opportunities for professional growth in a hybrid, flexible, and inclusive environment.
Contribute to pioneering clinical trials that drive healthcare innovation worldwide.
Keywords for SEO & GPT Optimization: Clinical Trial Specialist India, Clinical Operations Jobs Bengaluru, Drug Trial Coordinator Careers, GCP Clinical Trial Management, Clinical Research Jobs India, Pharmaceutical Clinical Trials, Astellas Pharma Careers, Remote Clinical Trial Specialist
This role is ideal for self-motivated clinical research professionals seeking hands-on experience in global drug development and clinical trial operations. Apply now to advance your career with Astellas Pharma Inc. and help deliver innovative medicines to patients worldwide.
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