Clinical Trial Specialist (#1751)
📍 Location: Bengaluru, India
🔗 Apply Now
Purpose and Scope
The Clinical Trial Specialist (CTS) will assist the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-day operations, setup, execution, and close-out of assigned clinical drug trials.
These may include:
Pre-/Post-Proof-of-Concept (POC) interventional drug trials
Clinical pharmacology (healthy volunteer) studies
Pre-approval access programs
Post-marketing regulatory commitment trials (interventional & non-interventional)
The CTS works collaboratively with global cross-functional teams and vendors to ensure operational excellence, regulatory compliance, and high-quality deliverables in accordance with GCP/ICH guidelines and company SOPs.
Reports to: Clinical Operations Functional Head / Manager / Clinical Operations Lead
Key Responsibilities & Accountabilities
Trial Operations Support
Support daily trial operations to ensure timely completion of objectives, milestones, and deliverables.
Collaborate with non-regional CTS members to maintain accurate and up-to-date trial information in tracking systems.
Provide regular trial status updates to the team and stakeholders.
Trial Setup & Execution
Participate in the development of trial plans, system setup, and implementation of trial standards and processes.
Assist in site feasibility assessments and maintain feasibility data for trial conduct.
Support CRO and vendor setup and management as requested by the Clinical Trial Lead or Clinical Team.
Contribute to Trial Master File (TMF) setup and ensure quality and completeness.
Documentation & Data Management
Participate in trial team meetings and manage meeting documentation.
Coordinate data cleaning, data reviews, and investigator or site monitor training as required.
Ensure accurate and complete documentation throughout trial lifecycle.
Patient & Site Support
Contribute to the development and implementation of patient-focused strategies.
Ensure compliance with all applicable regulations, GCP, SOPs, and internal standards during setup, conduct, and close-out of trials.
Location
📍 Bengaluru, India
Required Qualifications
Education: Bachelor’s degree (BA/BS) in a healthcare or related field.
Experience: Minimum 2 years of clinical trial experience in the healthcare industry.
Excellent interpersonal, written, verbal, presentation, and administrative skills.
Proficient in computer applications (MS Office, trial systems).
Fluent in English (oral and written).
General knowledge of clinical protocols, trial phases, drug development processes, and ICH/GCP guidelines.
Ability to travel occasionally (0–5%).
Preferred Qualifications
Advanced degree (Master’s or equivalent).
Working Environment
At Astellas, we value work-life balance through our hybrid working model, allowing flexibility to work from both the office and home as per Responsible Flexibility Guidelines.
This role offers a highly collaborative environment, occasional travel, and opportunities to work with cross-functional global teams.
⚠️ Recruitment Scam Notice
Beware of recruitment scams impersonating Astellas recruiters or representatives.
Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address.
If you encounter a fake profile or suspicious message, report it immediately to LinkedIn Help.
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