Clinical Trial Specialist
📍 Location: Bengaluru, India
🏢 Company: Astellas
Category: Clinical Research
Employment Type: Full-time
Purpose and Scope
The Clinical Trial Specialist (CTS) supports the Clinical Trial Lead and Clinical Trial Manager in the day-to-day operations, set-up, execution, and close-out of assigned clinical drug trials.
These may include:
Pre/Post-Proof of Concept (POC) interventional trials
Clinical pharmacology (healthy volunteer) studies
Pre-approval access programs
Post-marketing regulatory commitment trials (interventional & non-interventional)
The CTS collaborates with global, cross-functional teams and vendors to ensure proper trial setup, operational excellence, and adherence to SOPs, ICH-GCP, and regulatory standards.
Reports directly to the Clinical Operations Functional Head/Manager or Clinical Operations Lead.
Key Responsibilities
Support daily trial operations with urgency to meet project objectives, milestones, and deliverables in compliance with GCP/ICH and regulatory requirements.
Collaborate with global CTS team members to maintain accurate and current trial information in tracking systems; provide regular updates to the trial team and stakeholders.
Contribute to trial planning, system setup, and implementation of standardized processes to ensure quality across sites, vendors, and data.
Participate in site feasibility assessments and maintain related trial data.
Assist with CRO and vendor setup and management during trial execution.
Support Trial Master File (TMF) setup, maintenance, and quality control.
Participate in trial team meetings, prepare and manage documentation.
Support data cleaning and review activities as required.
Assist in investigator and site monitor training coordination.
Contribute to patient-focused strategies for trial conduct and engagement.
Ensure full compliance with GCP, SOPs, and company standards during trial setup, conduct, and close-out.
Required Qualifications
Education: Bachelor’s degree (BA/BS) in a life sciences, health sciences, or related discipline.
Experience: Minimum 2 years of clinical trial experience within the healthcare or clinical research field.
Skills:
Excellent interpersonal, written, verbal, and presentation skills.
Strong administrative and computer proficiency.
General understanding of clinical protocols, trial phases, ICH/GCP, and drug development processes.
Fluent in English (oral and written).
Travel: Minimal (0–5%).
Preferred Qualifications
Advanced degree (e.g., M.Sc., M.Pharm, Pharm.D, or related postgraduate qualification).
Experience working in global or cross-functional clinical research environments.
Working Environment
At Astellas, we value work-life balance and offer a hybrid work model, combining in-office collaboration with flexibility to work from home.
This approach supports productivity, collaboration, and employee well-being in alignment with our Responsible Flexibility Guidelines.
🧳 Travel: Minimal
🏢 Environment: Office-based hybrid setup
Equal Employment Opportunity
Astellas is committed to equality of opportunity in all aspects of employment.
We are an Equal Opportunity Employer (EOE) — including Disability/Protected Veterans.
⚠️ Recruitment Advisory
Beware of fraudulent job postings or fake recruiter profiles impersonating Astellas representatives.
Authentic communication will only come from:
Verified Astellas company email addresses, or
Official Astellas LinkedIn profiles.
If you encounter suspicious activity, report it promptly through LinkedIn Help.
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