Local Study Associate Director - LSAD

About Parexel

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!