Job Title: Clinical Trial Specialist
Company: Astellas
Location: Bengaluru, India
Job Type: Full-time, Hybrid (office + work from home)
Reports to: Clinical Operations Functional Head/Manager or Clinical Operations Lead
Travel: Minimal (0–5%)
The Clinical Trial Specialist supports Clinical Trial Leads and Managers in the day-to-day operations, set-up, execution, and close-out of assigned drug trials, including:
Pre/post-POC interventional drug trials
Clinical Pharmacology trials in healthy volunteers
Pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional)
The role ensures operational excellence, adherence to SOPs, GCP/ICH guidelines, and quality of trial deliverables while collaborating with global cross-functional teams and vendors.
1. Trial Operations & Support:
Assist with day-to-day operations of assigned trials with urgency and accuracy.
Support trial execution to meet project objectives, milestones, and deliverables.
Participate in site feasibility assessments and maintain related data.
Assist in CRO/vendor set-up and management during trial execution.
Participate in TMF (Trial Master File) set-up and maintenance for quality and completeness.
Support coordination of investigator and site monitor training.
Implement patient-focused strategies for assigned trials as applicable.
2. Collaboration & Documentation:
Collaborate closely with non-regional CTS team members to maintain accurate trial information in tracking systems.
Provide regular updates to trial teams and other stakeholders.
Participate in trial team meetings and manage associated documentation.
Support data cleaning and review coordination as requested.
3. Compliance & Quality:
Ensure compliance with GCP, ICH guidelines, SOPs, and regulatory requirements during trial set-up, conduct, and close-out.
Maintain high-quality trial processes and documentation.
BA/BS degree in a relevant field
Minimum 2 years of clinical trial experience in healthcare
Excellent interpersonal, written, verbal, presentation, and administrative skills
Proficiency in Microsoft Office and computer systems
Fluent in English (oral and written)
General knowledge of clinical protocols, drug development processes, clinical trial phases, and ICH/GCP guidelines
Advanced degree (Master’s or higher)
Experience with hybrid working environments and collaboration tools
Hybrid work model: combination of office and remote work
Collaborative environment with flexible work-life balance
Adherence to Astellas Responsible Flexibility Guidelines
Astellas is an equal opportunity employer (EOE) including Disability/Protected Veterans.
Commitment to equality of opportunity in all aspects of employment.
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