Local Study Associate Director

🔥 21 hours ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Director

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Oversee all aspects of clinical trial delivery from site identification and qualification through setup, monitoring, and closure • Lead and motivate Local Study Teams, including CRAs and CSAs • 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 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

🎯 Requirements

• 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 • 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

• 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)