When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
About ParexelParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.
About the RoleWe are 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.
You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic planning, regulatory coordination, and operational excellence. With diverse teams and continuous learning opportunities, the Clinical Research Associate II can explore career paths and expand skills across clinical research and regulatory operations.
Key Responsibilities- 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
You'll thrive in this role if you bring:
- 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
- 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
Skills Required
- Bachelor's degree
- 3-6 years 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)
- Experience with electronic Trial Master Files (eTMF)
- Experience with CTIS database and EU regulatory submission processes
- Proficiency in MS Office applications including Project, PowerPoint, Word, and Excel
- Familiarity with clinical trial initiation and study startup procedures
- Ability to triage and coordinate responses to regulatory RFIs
- Vendor management experience and ability to work with multiple stakeholders
- Strong interpersonal, leadership, and communication skills
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
