Clinical Trial Specialist (#1750)
📍 Location: Bengaluru, India
🔗 Apply Now
Purpose and Scope
The Clinical Trial Specialist (CTS) will support 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 trials with healthy volunteers
Pre-approval access programs
Post-marketing regulatory commitment trials (both interventional and non-interventional)
The CTS is accountable to the clinical trial team for ensuring smooth execution of trial activities. This role collaborates closely with global cross-functional teams and vendors to set up and execute trial processes with operational excellence and compliance to SOPs, GCP, ICH, and regulatory standards.
Reports to: Clinical Operations Functional Head / Manager / Clinical Operations Lead
Key Responsibilities & Accountabilities
Trial Operations Support
Support day-to-day clinical trial operations with urgency and accountability.
Ensure completion of assigned tasks per project milestones and deliverables in compliance with GCP/ICH and regulatory guidelines.
Collaborate with global CTS colleagues to maintain accurate and updated trial information within tracking systems.
Provide regular trial progress updates to the team and stakeholders.
Trial Setup & Execution
Participate in developing trial plans and implementing systems, standards, and processes for consistent quality across sites, vendors, and data.
Assist in site feasibility assessments and maintain feasibility data.
Support CRO and vendor setup and management as required by the clinical team.
Lead or participate in Trial Master File (TMF) setup and maintenance to ensure quality and completeness.
Documentation & Data Management
Participate in trial team meetings and manage associated documentation.
Support data cleaning and review activities as assigned.
Assist with investigator and site monitor training setup and coordination.
Patient & Site Support
Contribute to patient-focused trial strategies and ensure their implementation during trial conduct.
Maintain compliance with regulations, SOPs, and internal standards throughout the setup, conduct, and close-out phases.
Location
📍 Bengaluru, India
Required Qualifications
Education: Bachelor’s degree (BA/BS) in a healthcare or related scientific field.
Experience: Minimum 2 years of clinical trial experience in the healthcare industry.
Excellent interpersonal, communication (written & verbal), presentation, and administrative skills.
Proficient in computer systems and documentation tools.
Fluent in English (spoken and written).
General knowledge of clinical protocols, trial phases, drug development process, and ICH/GCP guidelines.
Willingness to travel occasionally (0–5%).
Preferred Qualifications
Advanced degree (e.g., Master’s or equivalent) preferred.
Working Environment
At Astellas, we value work-life balance through a hybrid working model, combining time in the office for collaboration with flexibility to work from home.
Hybrid work is permitted from specific locations under Astellas’ Responsible Flexibility Guidelines to promote productivity, innovation, and well-being across 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 any suspicious profiles or messages, report them immediately to LinkedIn Help.
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