PHARMAFull-time
Site Start Up EUCTR II
HYDERABAD (IN)HYBRIDPOSTED: 9/26/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
ROLE OVERVIEW
Support complex clinical trial initiation, focusing on EU CTR compliance and CTIS database management.
ROLE DEFINITION & RESPONSIBILITIES
- •Collaborate with Clinical Trial Management and Regulatory Affairs teams to develop study startup strategies.
- •Plan and execute complex EU Clinical Trial Application (CTA) submissions for Part II trials.
- •Identify and manage participating Member States and institutions within the CTIS database.
- •Collect, organize, and upload Member State and site-level documents for CTA submissions.
- •Monitor and report on Part II CTA progress against trial timelines.
- •Triage and coordinate responses to Requests for Information (RFI) from regulatory authorities.
- •Manage In Vitro Diagnostic Regulation (IVDR) ethics submissions.
- •Ensure all trial-related documents are properly archived in compliance with regulatory requirements.
Reporting Hierarchy: Reports to Clinical Trial Management / SSU Leadership
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree with 3-6 years of relevant experience in clinical research, study operations, or clinical trial management.
- Knowledge of ICH-GCP, EUCTR, and IVDR regulatory guidelines.
- Experience with trial management systems (CTMS) and electronic Trial Master Files (eTMF).
- Experience with CTIS database and EU regulatory submission processes.
- Proficiency in MS Office applications.
PREFERRED QUALIFICATIONS
- •Vendor management experience
- •Strong interpersonal and leadership skills
- •Proactive, self-disciplined work habits and excellent time management
REQUIRED VERIFIED SKILLS
EUCTR
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, PF, Paid leave, Professional development programs
IVDR
ORGANIZATION CONTEXT & CULTURE
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry.
TEAM SIZE: 22,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)
Culture: Committed to driving industry-leading innovation, patient-focused clinical trials, and collaborative growth.
EXPECTED CAREER ROADMAP
ICH-GCP
APPLICATION ADVISORY
CTMS
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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