PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Initiation Clinical Research Associate II
Seeking an Initiation Clinical Research Associate II (Site Start Up EUCTR II) to join our team in a Hybrid capacity at our Hyderabad office. As an Initiation Clinical Research Associate II, you will support complex clinical trial initiation activities that advance new treatments for patients. This position plays a key role in regulatory strategy planning, study startup execution, and ensuring compliance with EU Clinical Trials Information System (CTIS) requirements. You'll collaborate with cross-functional teams including Clinical Trial Management, Regulatory Affairs, and Clinical Transparency to drive successful trial launches across multiple European Member States.
Key Accountabilities :
• Collaborate with Clinical Trial Management and Regulatory Affairs teams to develop comprehensive study startup strategies, including key study milestones and country allocation plans for multi-country clinical trials
• Plan and execute complex EU Clinical Trial Application (CTA) submissions for Part II trials, ensuring compliance with CTIS database requirements and national regulatory guidelines across all participating Member States
• Identify and manage participating Member States, institutions, and Primary Investigators, capturing and maintaining accurate contact information and institutional details within the CTIS database throughout the trial lifecycle
• Collect, organize, and upload applicable Member State and site-level documents for CTA submissions, coordinating with Clinical Transparency on required redactions and ensuring all documentation meets regulatory requirements
• Monitor and report on Part II CTA progress against trial timelines, identifying risks and ensuring alignment with overall study objectives and regulatory milestones
• Triage and coordinate responses to Requests for Information (RFI) from regulatory authorities, working with relevant stakeholders to ensure timely and compliant submissions
• Manage In Vitro Diagnostic Regulation (IVDR) ethics submissions, collecting required documents and verifying compliance with country-specific IVDR requirements
• Identify and capture key study-level and Member State-level milestones including Study Start, Study Completion, Enrollment Start, Enrollment Completion, and any hold/restart/cancel dates within the CTIS database
• Ensure all trial-related documents are properly archived in compliance with regulatory requirements and company policies
Maintenance (from initiation through close out) :
• Strong interpersonal and leadership skills with the ability to influence cross-functional teams and build productive collaborations
• A data-driven approach to planning, executing, and problem-solving with proactive, self-disciplined work habits and excellent time management
• Effective verbal, written, and presentation communication skills with the ability to articulate complex regulatory concepts clearly
• Vendor management experience and comfort working with multiple stakeholders in a regulated environment
• A patient-focused mindset and strong attention to detail with commitment to regulatory compliance and data accuracy
Candidate Profile
• 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 and clinical trial processes
• Experience with trial management systems (CTMS) and electronic Trial Master Files (eTMF)
• Proficiency in MS Office applications including Project, PowerPoint, Word, and Excel
• Experience with CTIS database and EU regulatory submission processes
• Familiarity with clinical trial initiation and study startup procedures
Additional Information
Qualification : Bachelor's degree
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R0000042706
End Date : 20th September 2026
Clinical Research Associate : Apply here
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