Clinical Trial Specialist

By Admin · Clinical Research & Clinical Operations

BANGALORE (IN)HYBRIDPOSTED: 9/12/2026
PHARMAFull-time
HIRING ORGANIZATIONASTELLASPharmaceuticals and Life Sciences
Astellas

ROLE OVERVIEW

Support the end-to-end operational delivery of assigned clinical trials at Astellas, working with Clinical Trial Leads, Clinical Trial Managers, sites, CROs, vendors, and global cross-functional teams. The role focuses on quality, compliance, accurate trial execution, and operational excellence.

ROLE DEFINITION & RESPONSIBILITIES

  • •Support day-to-day operations of assigned clinical trials and ensure milestones and deliverables are completed
  • •Maintain accurate and current trial information in tracking systems and provide updates to stakeholders
  • •Participate in trial planning, system set-up, standards, and process implementation
  • •Support site feasibility assessments and associated trial data maintenance
  • •Participate in CRO and vendor set-up and management
  • •Participate in or lead TMF set-up and maintenance to ensure quality and completeness
  • •Participate in trial team meetings, data cleaning, data reviews, and investigator/site monitor training
  • •Support patient-focused strategies and ensure compliance with GCP, SOPs, regulations, and established standards
Reporting Hierarchy: Reports to Clinical Operations Functional Head, Manager, or Clinical Operations Lead; Works collaboratively with Clinical Trial Leads, Clinical Trial Managers, global cross-functional teams, investigative sites, CROs, and vendors

* Role responsibilities and qualifications synthesized based on industry benchmark standards.

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Bachelor's degree with at least 3 years of clinical trial experience or equivalent direct experience
  • OR MS/PhD/PharmD with at least 2 years of clinical trial experience
  • Strong knowledge of ICH/GCP guidelines and regulatory requirements
  • Knowledge of clinical drug development processes, protocol, clinical trial design, planning, management, and monitoring
  • Project management and trial leadership capability
  • Excellent interpersonal, written, verbal, administrative, and computer skills
  • Fluent in English

PREFERRED QUALIFICATIONS

  • •Advanced degree
  • •Experience supporting global clinical trial teams
  • •Experience with CRO and vendor management
  • •Strong TMF and clinical trial systems experience

REQUIRED VERIFIED SKILLS

ICH-GCP
clinical trial operations
clinical trial management
clinical trial design
protocol management
regulatory requirements
site feasibility
CRO management
vendor management
TMF management
data cleaning
data review
investigator training
clinical monitoring
project management

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Hybrid working; work/life balance support; global collaboration; professional growth opportunities
The posting does not disclose compensation. Salary figures should therefore not be inferred from the role or market benchmarks.

ORGANIZATION CONTEXT & CULTURE

Astellas is a global life sciences company focused on innovative therapies and transformative healthcare solutions across areas including oncology, ophthalmology, urology, immunology, and women's health.

TEAM SIZE: 10,000+ employees
INDUSTRY: Pharmaceuticals and Life Sciences
Culture: Astellas emphasizes innovation, integrity, and impact, with a collaborative 'One Astellas' culture focused on courage, urgency, outcomes, and accountability.

EXPECTED CAREER ROADMAP

Progression can lead toward Clinical Trial Lead, Clinical Trial Manager, Clinical Operations Lead, and broader clinical development or program management roles, depending on performance, trial experience, and leadership exposure.

APPLICATION ADVISORY

Highlight hands-on clinical trial experience, ICH-GCP knowledge, trial start-up and close-out exposure, TMF experience, CRO/vendor coordination, site feasibility work, and clinical operations systems knowledge. Quantify the number and phase of trials supported where possible.
RECOMMENDED TRAINING
1/5

READY TO SUBMIT?

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