[Hiring] Local Study Associate Director @Parexel

Role Description

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

Qualifications

• 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

Requirements

• 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

Benefits

• 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)