Local Study Associate Director - LSAD

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!

Originally posted on Himalayas