Manager, Study Start Up

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

📋 Description

• Oversee the daily activities related to site initiation and activation.

• Manage the comprehensive study start-up procedure, which includes site identification, feasibility assessments, regulatory submissions, and site activation.

• Lead a team of professionals focused on study start-up, offering guidance, mentorship, and support.

• Work in collaboration with sponsors, clinical operations, and regulatory teams to ensure adherence to local and global regulations and timelines.

• Track study start-up metrics, timelines, and budgets effectively.

• Recognize potential risks and challenges, and implement strategies to mitigate them.

• Promote continuous improvement initiatives to enhance study start-up processes and efficiency.

⛳️ Requirements

• A Bachelor's degree in a relevant scientific discipline or a healthcare-related field.

• Significant experience in clinical trial study start-up, with a deep understanding of global regulatory requirements and clinical operations.

• Demonstrated leadership abilities, with experience in managing and mentoring teams within a fast-paced, deadline-oriented environment.

• Exceptional organizational and project management skills, capable of managing multiple studies and competing priorities concurrently.

• Strong communication and stakeholder management abilities, facilitating effective collaboration with sponsors and internal teams.

• Experience in process optimization and the implementation of best practices in study start-up activities.

• Willingness to travel as needed (approximately 25%).

• Legal eligibility to work in Malaysia.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.