Clinical Trial Specialist
🆔 Job ID: 25-POS00082479
📍 Location: Bengaluru, India
🏢 Company: Astellas Pharma Inc.
💼 Type: Full-time
Purpose and Scope
The Clinical Trial Specialist (CTS) supports Clinical Trial Leads and Clinical Trial Managers in the setup, execution, and close-out of assigned drug trials. These may include:
Pre-/Post-Proof of Concept (POC) interventional trials
Clinical Pharmacology healthy volunteer studies
Pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional)
The CTS collaborates closely with global cross-functional teams and vendors to ensure trial operations meet SOPs, regulatory standards, and operational excellence benchmarks.
Reports directly to the Clinical Operations Functional Head, Manager, or Lead.
Key Responsibilities
1. Trial Operations Support
Assist in day-to-day clinical trial activities to ensure timely completion of project objectives and deliverables.
Maintain adherence to GCP/ICH guidelines, SOPs, and applicable regulations.
Collaborate with global CTS team members to keep trial tracking systems accurate and up-to-date.
Provide regular status updates to trial teams and key stakeholders.
2. Trial Set-up and Planning
Contribute to the development of trial plans, operational systems, and quality standards.
Participate in site feasibility assessments and maintain related data.
Support CRO/vendor setup and management during trial execution.
Assist in the Trial Master File (TMF) setup and maintenance, ensuring completeness and audit readiness.
3. Trial Execution and Documentation
Participate in trial team meetings and handle associated documentation.
Support data cleaning and review activities as assigned.
Coordinate and assist with investigator and site monitor training sessions.
Contribute to patient-focused strategies and engagement initiatives during the trial.
Ensure compliance with GCP, SOPs, and regulatory standards across all trial phases.
Required Qualifications
Education: Bachelor’s degree (BA/BS) in a health-related or life science field.
Experience: Minimum 2 years of clinical trial experience in the healthcare or pharmaceutical domain.
Strong interpersonal, written, and verbal communication skills.
Excellent administrative, presentation, and computer proficiency.
Fluent in English (oral and written).
General understanding of clinical protocols, drug development phases, and ICH/GCP guidelines.
Travel: Minimal (0–5%)
Preferred Qualifications
Advanced degree (e.g., MSc, PharmD, or equivalent).
Additional certification or training in clinical research or project management is advantageous.
Working Environment
Hybrid Work Model: Astellas supports a balanced work-life approach, offering a hybrid model that combines office collaboration with work-from-home flexibility.
This structure is guided by Astellas’ Responsible Flexibility Guidelines to promote productivity and teamwork.
⚠️ Important Notice on Recruitment
Beware of fraudulent job postings or recruitment scams. Authentic communication will only come from an official Astellas LinkedIn profile or verified company email.
If you encounter suspicious activity, report it immediately to LinkedIn Help.
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