Associate Director – Study Start Up

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

📋 Description

• Manage and ensure the timely delivery of the study start-up phase for assigned projects, adhering to scope, budget, and quality standards.

• Create and uphold study start-up plans while monitoring progress across designated protocols.

• Offer proactive advice to team members regarding site selection, submission strategies, amendment strategies, and client relations.

• Assist staff in addressing significant study or site challenges and escalate risks as necessary.

• Oversee assigned budgets, ensuring profitability and timely invoicing that aligns with the defined scope of work.

• Supervise local vendors and contractors, as necessary.

• Engage in business development activities, including proposal creation, budget formulation, and providing strategic insights on country and site selection.

• Manage staff within an international context, including responsibilities for training, coaching, mentoring, and identifying areas for process and training enhancement.

• Spearhead process improvement initiatives and serve as a key relationship manager for assigned clients.

• Collaborate closely with global functions such as Project Management, Data Management, Statistics, Medical Writing, Regulatory, and Safety.

⛳️ Requirements

• Bachelor’s degree, preferably in life sciences or nursing, or an equivalent qualification.

• At least 8 years of industry experience in clinical research, with a minimum of 5 years in global clinical trials.

• Comprehensive understanding of the clinical drug development process and study start-up phases.

• Strong knowledge of GCP/ICH guidelines and relevant regulatory requirements.

• Exceptional organizational, communication, customer service, and problem-solving abilities.

• Demonstrated capability to achieve results that meet quality, time, and financial standards.

• Strong judgment and decision-making skills.

• Ability to establish and maintain effective working relationships with colleagues, managers, and clients.

• Proficiency in English.

• Willingness and ability to travel as required.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development in a fulfilling environment.