Local Study Associate Director - LSAD

Parexel; Uxbridge; On-site; GBP 55,000 - 90,000; Full time

Benefits offered by this job

Travel opportunities (national and国际)

Competitive compensation

Comprehensive benefits package

Job summary

Parexel is seeking a skilled professional to oversee end-to-end delivery of clinical trials, ensuring adherence to ICH-GCP and local regulations. You will lead Local Study Teams, manage site activities, and coordinate regulatory submissions across multiple countries.

The role emphasizes risk management, budget oversight, and strong collaboration with investigators and authorities to drive timely, high-quality trial delivery.

Qualifications

• Minimum 3 years of experience in Development Operations (CRA/SrCRA) or related clinical research fields.
• Proven ability to lead 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.

Responsibilities

• Lead 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

Skills

Team leadership

Project management

Communication skills

ICH-GCP knowledge

Regulatory knowledge

Attention to detail

Negotiation skills

Education

Bachelor's degree in life sciences

Job description

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.

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

What We're Looking For

• 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)