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Clinical Trial Specialist Role – Astellas Pharma
Astellas Pharma is seeking a skilled and motivated Clinical Trial Specialist to join its team in Bengaluru, India. This Life Science Job at Astellas Pharma Careers supports the Clinical Trial Leads and Managers in managing the end-to-end operations of clinical studies, including trial setup, execution, and closeout. Clinical Research Jobs offers exciting opportunities to contribute to global drug development efforts while ensuring operational excellence and compliance with GCP/ICH guidelines.
Job Details:
- Position: Clinical Trial Specialist
- Location: Bengaluru, India
- Company: Astellas Pharma
- Category: Clinical Operations / Research & Development
- Job Type: Full-time
- Reports To: Clinical Operations Functional Head / Manager / Clinical Operations Lead
- Travel Requirement: Minimal (0–5%)
- Work Mode: Hybrid – as per Astellas’ Responsible Flexibility Guidelines
Purpose and Scope of Clinical Research Jobs:
This position will assist the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution, and close-out of assigned drug trials, including pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access, and post-marketing regulatory commitment trials (interventional and non-interventional).
This position is accountable to the clinical trial team for the support of the trial execution and works collaboratively with all global cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables. Reports directly to Clinical Operations Functional Head or Manager, or Clinical Operations Lead.
About the Company:
Astellas Pharma Inc. is a leading global pharmaceutical company dedicated to improving the health of people around the world through innovative and reliable pharmaceutical products. With a strong focus on transforming scientific innovation into patient-focused solutions, Astellas drives advancements in therapeutic areas such as oncology, immunology, urology, and more. The company fosters a collaborative and inclusive work culture by providing Clinical Research Jobs for candidates that support professional growth, innovation, and work-life balance.
Educational Requirements for the Clinical Trial Specialist Role:
- Bachelor’s degree (BA/BS) in a relevant health or life sciences discipline.
- Minimum of two years of clinical trial experience in the healthcare field.
- Advanced degree (Master’s or higher) preferred.
Key Responsibilities of the Clinical Trial Specialist Role:
- In this Clinical Research Job, you have to support daily clinical trial operations to ensure timely delivery of milestones and compliance with regulatory requirements.
- Collaborate with global cross-functional teams to maintain accurate trial data in tracking systems.
- Participate in developing and maintaining trial plans, site feasibility assessments, and system setups.
- Assist in managing CROs and vendors during clinical trial execution.
- Contribute to Trial Master File (TMF) setup and quality maintenance.
- Support investigator and site monitor training coordination.
- Participate in data review and cleaning processes.
- Ensure adherence to GCP, SOPs, and ICH guidelines throughout the trial lifecycle.
Skills Required for the Clinical Trial Specialist Role:
Technical & Functional Skills:
- Strong understanding of clinical trial processes and documentation standards.
- General knowledge of ICH/GCP guidelines and drug development phases.
- Experience with clinical trial management systems (CTMS) and documentation tools.
Soft Skills:
- Excellent communication (verbal and written) and presentation skills.
- Strong organizational and administrative abilities.
- Ability to collaborate across global teams and manage multiple priorities effectively.
- Proficiency in Microsoft Office applications.
- Fluent in English (oral and written).
How to Apply for this Life Science Job?
Interested candidates can visit the Astellas Pharma Careers Portal to apply online. Applicants can also set up email job alerts to receive notifications about future openings in clinical operations and related fields.
