Associate Regulatory & Start-Up Manager (Clinical Research, Flexible)

Job summary

This role involves supporting site activation and regulatory activities for clinical studies, working with cross-functional teams and global stakeholders. The position is designed for professionals looking to advance their careers in regulatory affairs within clinical research.

Qualifications

• Bachelor’s degree in a relevant scientific or clinical discipline.
• 2–3 years of experience in clinical research, with some exposure to leadership or coordination roles.
• Familiarity with clinical research processes, medical terminology, and regulations.

Responsibilities

• Assist in executing site activation and maintenance activities, including pre-award and bid defense tasks.
• Develop and maintain Regulatory & Start-Up Management Plans in line with project timelines.
• Define regulatory strategies and submission pathways.
• Prepare, review, and track regulatory and contractual documents for timely execution.
• Identify regulatory challenges and propose practical solutions.
• Monitor site performance metrics and ensure compliance with SOPs, GCP, ICH, and relevant regulations.
• Collaborate with regional and global teams to achieve study milestones.
• Maintain accurate records in CTMS and other tracking tools.
• Support Quality Management activities to uphold standards.
• Contribute to client communications and training as necessary.
• Assist in budget planning and study tracking activities.
• Mentor or support junior colleagues to develop leadership skills.

Skills

• Strong communication, organizational, and interpersonal abilities.
• Proficient in managing multiple tasks with attention to detail.
• Ability to work independently and collaboratively.
• Proactive, solution-oriented mindset with strong relationship-building skills.

Education

• Bachelor’s degree in a related scientific or clinical field.

Tools

• Experience with clinical systems and strong proficiency in Microsoft Office.