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 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 an Associate Clinical Operations Leader to join our team in Bengaluru in remote capacity. As an Associate Clinical Operations Leader, you will take on Clinical Operations Leader responsibilities for assigned countries or selected tasks, supporting clinical research activities that advance new treatments for patients. This position plays a key role in study execution, ICH-GCP and regulatory compliance, and clinical data quality. You will work under the guidance of an experienced Clinical Operations Leader, collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from start-up through close-out. Responsibilities include coordinating clinical teams on small to midsize projects, serving as a role model and coach for your team, and managing site and study issues, with opportunities to deepen your expertise and influence study outcomes. This role may also be part of a global project management team. You will join a fast-paced, growth-oriented environment focused on making a meaningful impact through study start-up, site performance, and timely, high-quality study delivery. With diverse teams and continuous learning opportunities, the Associate Clinical Operations Leader can explore career paths and expand skills across clinical research. Key Responsibilities Coordinate and direct clinical project team members on small to midsize studies, providing productivity targets, performance feedback, and input to study-specific training Manage study start-up activities, including input to project plans, site selection strategy, monitoring plans, and patient recruitment and retention plans Monitor study timelines, patient recruitment, patient retention, and data cleaning to support a successful project outcome Address escalated site issues and drive them to closure, identifying potential problems early and supporting contingency planning Communicate effectively with internal and external customers, sponsors, investigational sites, and third-party vendors, prioritizing urgent requests Evaluate resourcing needs and monitor the use of resources across the project life cycle Prepare for and participate in audits and inspections, and support the maintenance and quality checks of central files Ensure compliance with ICH-GCP, local regulatory requirements, and Parexel SOPs, work instructions, and operational guidelines Collaborate on database lock, project close-out, and archiving activities with Project Leaders and Data Operations Leaders Support process improvement initiatives and contribute lessons learned at study close-out Candidate Profile You will thrive in this role if you bring: Strengths in leading virtual teams across locations and cultures, negotiating and influencing with diplomacy, and root cause analysis Substantial experience in clinical research, with an understanding of cross-functional activities in data processing, data cleaning, and site management The ability to collaborate across teams, build trust with clients and colleagues, and communicate clearly in writing and in person A commitment to high-quality work, strong attention to detail, and a sense of urgency Proficiency with Microsoft Office (Excel, Word, PowerPoint, Outlook) and WebEx, and the ability to become proficient with Parexel systems Required Qualifications Degree in a life science or a nursing qualification, or relevant clinical or clinical management experience Substantial relevant work experience in clinical research operations, such as Clinical Research Associate (CRA) experience or equivalent Knowledge of International Council for Harmonisation (ICH) Good Clinical Practice (GCP), regulatory requirements, and clinical trial processes across the full project life cycle Strong command of written and spoken English, with local language proficiency as required Strong communication, organization, and problem-solving skills, with the ability to manage multiple tasks and prioritize workload with attention to detail Preferred Qualifications Coordinating experience, preferably gained in a Senior CRA or Senior CMA position On-site monitoring experience Local language proficiency for assigned countries Ability to travel as required We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research. If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Associate Clinical Operations Leader.

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Job Posting Title Clinical Operations Leader / 臨床開発部クリニカルオペレーションズリーダー

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