PHARMAFull-time
Initiation Clinical Research Associate II
HYDERABAD (IN)HYBRIDPOSTED: 8/13/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
ROLE DEFINITION & RESPONSIBILITIES
Plan and execute complex EU Clinical Trial Application (CTA) submissions for Part II trials in compliance with CTIS database requirements and national regulatory guidelines.
Coordinate with Clinical Trial Management, Regulatory Affairs, and Clinical Transparency teams to establish study startup strategies and Member State allocation plans.
Collect, organize, and upload site-level documentation, ensuring proper document redaction and regulatory compliance across European Member States.
Triage and manage Responses to Requests for Information (RFI) from regulatory authorities and handle In Vitro Diagnostic Regulation (IVDR) ethics submissions.
Track and maintain key trial milestones (Study Start, Enrollment, Holds/Restarts) in the CTIS database and ensure eTMF document archiving.
REQUIRED VERIFIED SKILLS
Clinical Trial Application (CTA)
CTIS Database
EUCTR
IVDR Submissions
Site Start-Up
ICH-GCP
Regulatory Affairs
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Parexel is a leading global clinical research organization (CRO) that provides comprehensive biopharmaceutical services. They partner with pharmaceutical, biotechnology, and medical device companies to accelerate the development and market access of innovative therapies. Their services span the entire drug development lifecycle, from early-phase clinical research to regulatory consulting and commercialization.
TEAM SIZE: 20,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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