Local Study Associate Director

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee all facets of clinical trial execution, from site identification and qualification to setup, monitoring, and closure.

• Lead and inspire Local Study Teams, comprising CRAs and CSAs.

• Ensure clinical trials are delivered punctually, within budget, and to the highest quality standards.

• Manage activities related to site identification, qualification, setup, initiation, monitoring, and closure.

• Supervise and coordinate monitoring activities from site activation through study closure, in line with monitoring plans.

• Ensure adherence to Client Procedural Documents, ICH-GCP guidelines, and local regulations.

• Develop and sustain risk management plans; proactively identify and address complex study challenges.

• Handle trial essential documents, including Informed Consent Forms and regulatory submissions.

• Prepare and oversee country-level financial Study Management Agreements and budgets.

• Collaborate with regulatory authorities, ethics committees, and national investigators.

• Contribute to patient recruitment strategies and maintain relationships with participating investigators.

• Conduct site monitoring as necessary to support adaptable capacity models.

⛳️ Requirements

• A minimum of 3 years of experience in Development Operations (CRA/SrCRA) or related clinical research domains.

• Demonstrated ability to lead and inspire cross-functional teams to achieve results on time and within budget.

• Exceptional project management, organizational, and communication skills (both verbal and written).

• In-depth knowledge of ICH-GCP guidelines and local regulations.

• Bachelor's degree in life sciences or a related field.

• Strong attention to detail and the ability to prioritize multiple tasks effectively.

• Good negotiation skills and proficiency in working with IT systems.

• Medical knowledge and understanding of drug development processes.

• Robust analytical and financial management capabilities.

• Comprehensive understanding of clinical study processes, including monitoring and data management.

• Good intercultural awareness and experience in change management.

• Basic coaching and crisis management abilities.

🏝️ Benefits

• Opportunities for professional development and career advancement within a global organization.

• Competitive salary and a comprehensive benefits package.

• A collaborative work environment with skilled professionals.

• Travel opportunities (both national and international as required).