Astellas is hiring for the position of Clinical Trial Specialist in Bengaluru, India, offering an excellent career opportunity for experienced professionals looking to advance in clinical research and clinical trial operations.

The Clinical Trial Specialist will support Clinical Trial Leads and Clinical Trial Managers with the set-up, execution, day-to-day management, and close-out of assigned clinical trials. The position involves working with global cross-functional teams, investigative sites, CROs, and vendors while ensuring compliance with ICH-GCP, regulatory requirements, SOPs, and clinical trial standards.

Candidates with a bachelor’s degree and at least three years of relevant clinical trial experience may be considered. Candidates holding advanced degrees such as MS, PhD, or PharmD require at least two years of clinical trial experience according to the job description.

Astellas Clinical Trial Specialist Job Overview

*Salary is an editorial estimate for similar clinical research roles in Bengaluru and is not an employer-disclosed salary. Actual compensation may vary based on experience, qualifications, responsibilities, and Astellas compensation policies.

About the Clinical Trial Specialist Role

The Clinical Trial Specialist at Astellas supports the operational delivery of assigned drug trials throughout the clinical trial lifecycle.

The position may support pre- and post-proof-of-concept interventional drug trials, Clinical Pharmacology studies involving healthy volunteers, pre-approval access programs, post-marketing regulatory commitment trials, and both interventional and non-interventional studies.

The selected professional will work closely with Clinical Trial Leads, Clinical Trial Managers, global cross-functional teams, CROs, investigative sites, and external vendors to ensure clinical studies are established and executed efficiently.

Key Responsibilities

As a Clinical Trial Specialist, your responsibilities may include:

• Support day-to-day clinical trial operations and ensure assigned activities are completed according to project objectives, milestones, and deliverables.
• Ensure trial activities comply with applicable ICH-GCP guidelines, regulatory requirements, SOPs, and established standards.
• Collaborate with Clinical Trial Specialist team members and global stakeholders to maintain accurate and current clinical trial information.
• Maintain relevant clinical trial tracking systems and provide regular updates to the trial team and defined stakeholders.
• Participate in the development of clinical trial plans and operational systems.
• Support trial system set-up and implementation of appropriate processes and standards.
• Help ensure quality across investigative sites, clinical trial vendors, and trial data.
• Participate in clinical trial site feasibility assessments and maintain associated feasibility information.
• Support CRO and vendor set-up and management during clinical trial execution.
• Participate in or lead Trial Master File (TMF) set-up and maintenance.
• Ensure TMF documentation remains complete, accurate, and of appropriate quality.
• Participate in clinical trial team meetings and manage associated documentation when required.
• Support coordination of clinical data cleaning and data review activities.
• Assist with investigator and site monitor training arrangements.
• Support patient-focused strategies for assigned clinical trials when appropriate.
• Contribute to clinical trial set-up, conduct, execution, and close-out activities.

Qualification & Experience Requirements

According to the Astellas job description, candidates should meet one of the following experience and education combinations:

Option 1 – Bachelor’s Degree

• BA/BS degree or relevant equivalent qualification
• At least 3 years of clinical trial experience or directly equivalent experience

Option 2 – Advanced Degree

Candidates with an advanced degree such as:

• MS
• PhD
• PharmD

should have at least 2 years of clinical trial experience.

An advanced degree is also listed by Astellas as a preferred qualification.

Important: This is not advertised as a fresher position. Relevant hands-on clinical trial experience is required.

Skills Required

Candidates applying for the Astellas Clinical Trial Specialist Bengaluru position should have strong knowledge or experience in:

• ICH-GCP Guidelines
• Clinical Trial Operations
• Clinical Research
• Clinical Drug Development
• Clinical Trial Design
• Trial Planning
• Clinical Trial Management
• Clinical Trial Monitoring
• Trial Master File (TMF)
• Site Feasibility
• CRO Management
• Vendor Management
• Clinical Trial Documentation
• Data Cleaning and Review
• Regulatory Requirements
• Clinical Trial SOPs
• Project Management
• Trial Leadership
• Cross-functional Collaboration
• Stakeholder Management
• Written and Verbal Communication

Fluency in English is required.

Who Can Apply?

Professionals working in clinical research, clinical operations, clinical trial management, TMF, site management, trial coordination, or related clinical development functions may find this opportunity relevant if they meet Astellas’ education and experience requirements.

Candidates with backgrounds such as PharmD, pharmacy, life sciences, clinical research, biotechnology, biomedical sciences, or related disciplines may be relevant where their degree meets the employer’s BA/BS or advanced-degree requirement and they possess the required clinical trial experience.

Candidates should rely on the employer’s application screening for final degree-equivalency determination because the job description does not provide an exhaustive list of eligible academic disciplines.

Knowledge of ICH-GCP Is Important

Astellas specifically requires strong knowledge of ICH-GCP guidelines and applicable regulatory requirements.

Applicants should understand areas including clinical trial protocols, clinical drug development processes, study design, trial planning and management, clinical monitoring, site activities, documentation, and regulatory compliance.

These competencies are particularly important because the Clinical Trial Specialist supports studies throughout trial set-up, conduct, execution, and close-out.

TMF and Site Management Responsibilities

One important component of this Clinical Trial Specialist position is involvement with the Trial Master File (TMF).

The selected candidate may participate in or lead TMF set-up and ongoing maintenance to ensure documentation is complete and meets applicable quality standards.

The role also provides exposure to:

• Site feasibility
• Investigator sites
• CRO coordination
• Vendor management
• Investigator training
• Site monitor training
• Clinical data reviews
• Trial documentation

This makes the position particularly relevant for experienced clinical operations professionals seeking broader global trial-management exposure.

Work Environment

The position is based at Astellas’ Global Capability Center in India.

Astellas describes the role as operating under a hybrid working model, combining opportunities to work with colleagues in the office with flexibility to work from home in accordance with the company’s Responsible Flexibility Guidelines.

The role also requires approximately 25% travel.

Why Join Astellas?

Astellas highlights several aspects of working with the organization:

Global Collaboration

Employees can collaborate with global life science professionals working toward developing therapies for patients worldwide.

Patient Impact

Clinical operations professionals contribute to the development and delivery of therapies intended to address significant unmet medical needs.

Innovation

Astellas operates across therapeutic areas including oncology, ophthalmology, urology, immunology, and women’s health.

Career Development

The company describes a work environment designed to support professional development, collaboration, accountability, and individual growth.

How to Apply

Application Link