Study Start Up Associate

• Facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements
• Deliver site start-up and activation work to a high standard
• Prepare and submit regulatory documents, such as clinical trial applications and ethics committee submissions
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Maintain accurate and up-to-date records of regulatory submissions and approvals
• Support study teams in developing study documents, including protocols, informed consent forms, and investigator brochures
• Participate in study start-up meetings and provide input on regulatory requirements and timelines

• Bachelor's degree in life sciences or a related field
• Experience in submission, substantial and non-substantial amendments Mexico
• Previous experience in clinical research or regulatory affairs preferred, but Nt required
• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
• Willingness to travel as required (approximately 5%)
• Legal right to work in the country where the role is based

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways