Study Start Up Associate II

Study Start Up Associate II (Supporting reputed company America region - US/CAN) reputed company is a global reputed company intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, reputed company, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. We are currently seeking a Study Start Up Associate II (Site Activation Partner) to join our diverse and dynamic team. As a Study Start Up Associate II at reputed company, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies. In this role you will be responsible for leading or supporting operational activities from start-up to reputed company-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Sponsor standards. Responsibility reputed company a country and may reputed company over more than one country depending on the geographical region and business needs. What you will be doing Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation reputed company, for internal regulatory approval reputed company required timelines Support investigators sites with local IRB workflow from preparation, submission through approval Accurately update and maintain clinical trial systems that track site compliance and performance reputed company project timelines Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests Coordinating and liaising with reputed company stakeholders to obtain necessary approvals and authorizations for study initiation. Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities. Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency. Your profile Bachelor's degree in life sciences or a reputed company field. Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities. Candidates must have reputed company good level of English and experience working with US, as will reputed company support to NAM. Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements. Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams #LI-Remote Employment with reputed company is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits reputed company offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive reputed company salary and performance reputed company incentives Health and wellbeing programmes including medical, dental, and reputed company 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 reputed company Benefits may vary depending on role and location. Visit our careers site to read more about the benefits reputed company offers. Inclusion and Accessibility reputed company 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 reputed company reputed company Employee? Please click here to apply Apply To This Job