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Clinical Trial Specialist

Astellas
Astellas
2+ years
preferred by company
10 Dec. 30, 2025
Job Description
Job Type: Full Time Hybrid Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Specialist

Job ID: 25-POS00082458M
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Work Model: Hybrid (Office + Remote as per policy)
Functional Area: Clinical Operations | Clinical Research
Experience Required: Minimum 2+ Years


About the Role

The Clinical Trial Specialist will support Clinical Trial Leads and Clinical Trial Managers in the end-to-end execution of assigned clinical studies. This role is critical to ensuring the smooth setup, conduct, and close-out of interventional and non-interventional drug trials, including early-phase, clinical pharmacology, post-marketing, and regulatory commitment studies.

The position collaborates closely with global cross-functional teams and vendors to ensure clinical trials are executed with operational excellence, in compliance with ICH-GCP guidelines, SOPs, and regulatory standards.


Key Responsibilities

  • Support day-to-day clinical trial operations with a strong sense of urgency to meet project milestones and deliverables.

  • Assist in the setup, execution, and close-out of clinical trials in compliance with ICH-GCP, SOPs, and applicable regulatory requirements.

  • Maintain accurate and up-to-date trial information across clinical tracking and reporting systems.

  • Collaborate with global CTS team members, trial teams, and stakeholders to provide timely updates and documentation.

  • Participate in trial planning, system setup, and implementation of standardized processes to ensure data and operational quality.

  • Support site feasibility assessments and maintenance of site-related data.

  • Assist in CRO and vendor setup, coordination, and oversight during trial execution.

  • Support Trial Master File (TMF) setup, maintenance, and quality checks.

  • Participate in trial team meetings and manage associated documentation.

  • Coordinate data cleaning activities and data review processes as required.

  • Support investigator meetings, site monitor training, and patient-focused trial strategies.

  • Ensure adherence to regulatory requirements, SOPs, and quality standards throughout the trial lifecycle.


Education & Experience Requirements

  • Bachelor’s degree (BA/BS) in Life Sciences, Pharmacy, Healthcare, or a related discipline.

  • Minimum 2+ years of experience in clinical trial operations or a healthcare research environment.

  • Strong understanding of clinical trial phases, clinical protocols, and drug development processes.

  • Working knowledge of ICH-GCP guidelines and regulatory requirements is preferred.

  • Advanced degree is an advantage but not mandatory.


Skills & Competencies

  • Excellent interpersonal, written, and verbal communication skills.

  • Strong organizational and administrative capabilities.

  • Proficiency in computer applications and clinical documentation systems.

  • Ability to work collaboratively in a global, cross-functional environment.

  • High attention to detail and ability to manage multiple priorities effectively.

  • Fluency in English (spoken and written) is required.


Work Environment

This role follows a hybrid working model, offering flexibility to work both from the office and remotely, in line with company guidelines. The position involves minimal travel (0–5%) and operates in a highly collaborative, global clinical research environment.


Why Join

  • Opportunity to work on global clinical trials across multiple phases.

  • Exposure to cross-functional teams and international stakeholders.

  • Flexible hybrid work environment supporting work-life balance.

  • Career growth within a structured clinical operations framework.


Important Notice

Candidates are advised to be cautious of recruitment scams. All legitimate communications will originate from official company email addresses or verified LinkedIn profiles.


Apply now via ThePharmaDaily.com to advance your career in clinical trial operations and contribute to the development of innovative therapies.