Regional Site Start Up II

About Parexel

Parexel 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 Role

We are seeking a Regional Site Start Up II to join our team in a Hybrid (Hyderabad) capacity. As a Regional Site Start Up II, you will support clinical research activities that advance new treatments for patients by leading site activation and start-up initiatives across assigned geographic regions. This position plays a key role in ensuring timely site activation, regulatory compliance, and operational readiness. You'll collaborate with clinical sites, internal stakeholders, and cross-functional teams to drive efficient site onboarding from planning through activation. Responsibilities include managing site activation timelines, coordinating regulatory documentation, and ensuring adherence to study milestones, with opportunities to deepen your expertise in clinical trial operations and influence study outcomes.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic site partnerships, regulatory excellence, and operational efficiency. With diverse teams and continuous learning opportunities, the Regional Site Start Up II can explore career paths and expand skills across clinical research and trial management.

Key Responsibilities

• Lead site activation and start-up activities for assigned clinical trial sites, ensuring timely achievement of individual site activation milestones and regulatory readiness
• Gather, organize, and coordinate essential regulatory documents from clinical sites and sponsors, ensuring compliance with regulatory requirements and sponsor-specific guidelines throughout the site activation process
• Collect and maintain site intelligence to inform strategic site discussions, troubleshoot activation challenges, and provide solutions that keep projects on track
• Ensure site regulatory packages meet country-specific requirements, Trial Master File standards, and ICH-GCP compliance guidelines
• Serve as the primary regional point of contact for assigned sites, providing expert guidance on geographic-specific challenges and escalating issues for timely resolution
• Maintain accurate activation progress records, including document collection status, regulatory submissions, and timeline updates in trial management systems
• Support inspection readiness activities by ensuring all site start-up documents are properly filed in the Trial Master File and organized for regulatory review
• Identify opportunities for process improvement in site start-up activities and implement best practices to enhance efficiency and effectiveness across trials
• Partner with internal teams, external stakeholders, and clinical sites to ensure clear communication, coordination, and alignment throughout the site activation phase

You'll thrive in this role if you bring:

• Demonstrated interpersonal and leadership skills with the ability to build strong relationships across diverse teams and stakeholders
• A data-driven approach to planning, executing, and problem solving with excellent attention to detail
• Strong verbal, written, and presentation communication skills that enable clear collaboration across teams
• Proactive and self-disciplined with proven ability to manage multiple priorities, meet deadlines, and optimize time management
• Experience working in clinical research, healthcare, or regulated environments
• A patient-focused mindset and commitment to regulatory compliance and quality standards

Required Qualifications

• Bachelor's Degree
• 3 to 4 years of experience in clinical research, study operations, or site management
• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
• Experience with Clinical Trial Management Systems (CTMS), Trial Master File (TMF) systems, and Microsoft Office applications (Project, PowerPoint, Word, Excel)
• Strong communication, organization, and problem-solving skills with demonstrated vendor management experience

Preferred Qualifications

• Experience in site start-up, site activation, or clinical trial initiation activities
• Familiarity with electronic Trial Master File (eTMF) systems and regulatory documentation standards
• Experience supporting regulatory inspections or audit readiness activities
• Multilingual capabilities or experience in international clinical trial operations