Clinical Trial Specialist (#1751)
📍 Location: Bengaluru, India
🏢 Company: Astellas
🔗 Apply: [Apply Now]
Purpose and Scope
The Clinical Trial Specialist (CTS) supports the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the setup, execution, and close-out of assigned drug trials.
This includes:
Pre/Post-Proof of Concept (POC) interventional drug trials
Clinical Pharmacology (healthy volunteer) studies
Pre-approval access and post-marketing regulatory commitment trials (interventional & non-interventional)
You’ll work collaboratively with cross-functional global teams and vendors to ensure trials are executed with operational excellence, quality, and in compliance with GCP/ICH guidelines and SOPs.
📈 Reports To: Clinical Operations Functional Head/Manager or Clinical Operations Lead
Key Responsibilities
Trial Operations
Support day-to-day clinical trial activities with urgency and precision to meet project milestones.
Ensure all operations comply with GCP/ICH, regulatory requirements, and internal standards.
Maintain accurate, up-to-date trial data in tracking systems and provide updates to stakeholders.
Trial Planning & Setup
Participate in the creation of trial plans and system setup.
Contribute to site feasibility assessments and maintain associated data.
Assist in CRO/vendor setup and management during trial execution.
Support Trial Master File (TMF) setup and ensure quality/completeness of documentation.
Coordination & Communication
Attend and document trial team meetings.
Coordinate data cleaning and data review activities.
Support investigator and site monitor training sessions.
Contribute to patient-focused strategies and engagement activities.
Compliance & Quality
Uphold all SOPs, regulations, and ethical standards throughout the trial lifecycle.
Qualifications
Required
Bachelor’s degree (BA/BS) in a health care or life science discipline.
2+ years of clinical trial experience in the healthcare field.
Strong interpersonal, communication, and presentation skills.
Proficiency in MS Office and digital trial systems.
Fluency in English (spoken and written).
Basic understanding of clinical protocols, drug development, and clinical trial phases.
Ability to travel up to 5%, as required.
Preferred
Advanced degree (MSc/PharmD/MPH or equivalent).
Prior experience in global clinical operations or vendor coordination.
Work Environment
Astellas values work-life balance and offers a hybrid work model — blending in-office collaboration with flexible remote work options, per Responsible Flexibility Guidelines.
Additional Information
⚠️ Beware of Recruitment Scams:
All authentic communications will originate only from official Astellas LinkedIn profiles or verified company email addresses.
If you encounter suspicious activity, report it immediately via LinkedIn Help.
Summary
The Clinical Trial Specialist plays a vital role in ensuring the seamless operational delivery of clinical trials at Astellas — from planning to close-out. This position demands strong organizational skills, attention to detail, and collaboration across global teams to support high-quality clinical research outcomes.
Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Canada |Quebec :
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Brussels |Antwerp :
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Sao paulo | Brazil |Attica :
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Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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