Study Start Up Associate

Sr SSUA - Malaysia ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. As a Study Start Up Associate at ICON, you will facilitate the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies. What You Will Do: Your role will involve delivering site start-up and activation work to a high standard, working closely with your team and stakeholders. Key responsibilities include: Assisting in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions. Coordinating with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation. Maintaining accurate and up-to-date records of regulatory submissions and approvals. Supporting study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures. Participating in study start-up meetings and providing input on regulatory requirements and timelines. Your Profile: You will bring relevant site start-up and activation experience, along with the following qualifications and skills. Required qualifications and experience: Bachelor's degree in life sciences or a related field. Must have experience in startup activities in clinical research (submissions, contracts and budget, site activation) Experience in Phase I submissions is highly preferred 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%) Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here. Are you a current ICON Employee? Please click here to apply Apply To This Job