Study Start Up Associate II / Senior (Regulatory Submissions)

Job description

Study Start Up Associate II / Senior (Regulatory Submissions) 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. We are currently seeking a Site Partner ( Study Start Up Associate II / Senior - Regulatory Submissions with clinical trials experience ) to join our diverse and dynamic team. As a Site Partner at ICON, you will independently manage relationships with a portfolio of investigator sites, supporting their engagement and performance across studies. You will act as a trusted liaison, advocating for site needs internally while supporting ICON processes and expectations. What You Will Be Doing: • Preparation and supply of site documentation required for regulatory submissions CEP/CONEP. in CROs • Ensure timely ethics submission of protocol and study documents/safety reports for local ethics/IRB approval according to local requirements. • Expert knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems • Accountable for the expert level independent and proactive co-ordination of all necessary activities required to achieve timely site activations and maintenance tasks for any given site(s) across a single or multiple studies. • In collaboration and feedback from the site, ensure CDP and Site Activation approval dates are forecast and planned accurately in ICON’s systems, documenting all risks to delivery with mitigations taken, as they occur. • Drive CDP and site activation timelines and ensure they are reflected accurately in ICON’s systems and are achieved; proactively follow through for achievement to/or ahead of plan; provide risk assessment and contingency plans at a site and country level, to mitigate impact if forecasted timelines are at risk; escalate issues as soon as identified • Accurate site and country adaptation and customization of Patient Informed Consents • Prepare, collect and collate all requirements for site Critical Package Documents (CDPs) for review and approval prior to site activation in accordance with ICON SOPs/WPs, Sponsor requirements, applicable country regulations/guidelines and the principles of ICH/GCP, ensuring the highest quality, accuracy and completeness of site and country documentation is obtained in the TMF. • Coordination, verification and back translation of all necessary translations required for any start-up or maintenance documentation. • May be involved in the Site Selection tasks and qualification of a given site • Act as site liaison and escalation point of contact; proactively resolving issues to ensure the site receives a positive customer experience. • Work with key stakeholders to optimize performance and collaborate to ensure successful project outcomes • Communicate all relevant Sponsor / FSA Project Manager /Country / CTM instructions or updates to the Site • Assume responsibility as Subject Matter Expert (SME) for the required topics, ensuring knowledgeable and updated in any changing regulatory requirements. Your Profile: • Bachelor’s degree in life sciences, healthcare, business, or a related field, or equivalent clinical research experience. • Experience with ethics submissions (CEP/CONEP) within CROs. • Experience in site-facing roles such as Study Start-Up, Regulatory Associate, Site Activation Specialist, Site Activation Coordinator, or similar positions within CROs. • Experience in country ICF preparation. • Experience with MoH submissions is considered a strong plus and may be required to support these processes. • Fluent in English (written and spoken). • Good understanding of site operations and factors influencing recruitment and quality. • Organized and proactive, with the ability to manage multiple sites and competing priorities. • Collaborative team player with a commitment to delivering a high-quality site experience. #LI-Hybrid #LI-FP1 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? 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