Local Study Associate Director - LSAD
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Role Overview
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.
Full Job Posting
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
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)
About Parexel
Global clinical research organization providing drug development services.
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