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The Local Study Associate Director oversees all aspects of clinical trial delivery, including site management, monitoring, and regulatory compliance. They are responsible for leading cross-functional teams to ensure trials are completed on time, within budget, and to high quality standards.
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
In this role, you will oversee all aspects of clinical trial delivery—from site identification and qualification through setup, monitoring, and closure—ensuring compliance with international guidelines (ICH-GCP) and local regulations.
Key Responsibilities
Lead and motivate Local Study Teams (CRAs, CSAs) to deliver clinical trials on time, within budget, and to the highest quality standards
Manage site identification, qualification, setup, initiation, monitoring, and closure activities
Oversee and coordinate monitoring activities from site activation through study closure in accordance with monitoring plans
Ensure compliance with Client Procedural Documents, ICH-GCP guidelines, and local regulations
Develop and maintain risk management plans; proactively identify and resolve complex study issues
Manage trial essential documents, including Informed Consent Forms (ICFs) and regulatory submissions
Prepare and maintain country-level financial Study Management Agreements and budgets
Coordinate with regulatory authorities, ethics committees, and national investigators
Contribute to patient recruitment strategy and maintain relationships with participating investigators
Perform site monitoring as needed to support flexible capacity models
What We're Looking For
Essential:
Minimum 3 years of experience in Development Operations (CRA/SrCRA) or related clinical research fields
Proven ability to lead and motivate cross-functional teams to deliver results on time and within budget
Excellent project management, organizational, and communication skills (verbal and written)
Strong knowledge of ICH-GCP guidelines and local regulations
Bachelor's degree in life sciences or related discipline
Excellent attention to detail and ability to prioritize multiple tasks
Good negotiation skills and ability to work effectively with IT systems
Desirable:
Medical knowledge and understanding of drug development processes
Strong analytical and financial management skills
Excellent understanding of clinical study processes, including monitoring and data management
Good intercultural awareness and change management experience
Basic coaching and crisis management skills
What We Offer
Opportunity to lead dynamic teams in cutting-edge clinical research
Professional development and career growth in a global organization
Competitive compensation and comprehensive benefits package
Collaborative work environment with talented professionals
Travel opportunities (national and international as required)
Apply now to make an impact on clinical trial delivery!
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