Senior Project Manager At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organisation, with over 90 sponsor partnerships,

we offer
stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. ICON PLC seeks an experienced Trial Clinical Delivery Lead (TCDL). The TCDL will work in the Functional Service Provision Division of ICON PLC. The TCDL will work directly with a large multinational pharmaceutical company. Clinical Development Studies Utilise site performance and quality data analytics to drive risk-based sponsor oversight activities for investigational sites in outsourced studies Represent the CSL group at the Clinical Operations Team (COT)/Trial Team (TT) via: Regular review meetings of study/site performance and quality metrics and the associated strategic action planning Ad hoc interactions to address immediate issues Other COT/TT meetings as appropriate e.
G. kick-off meeting Consolidate data-driven, CSL assessment of country and site selection proposals, ensuring quality and consistency across regions and countries to support TT decision making; inform CSLs of resulting choices of regions/countries/sites Design country start-up strategy in consultation with the Start-up Solutions Team and Country Start-up Specialists (CSS), and in alignment with the CTL(s) and CRO(s). Work closely with the CSS to oversee and ensure delivery at the site and country level Establish monitoring strategy, including management of identified risks, in collaboration with the CTL(s) and CRO(s) and incorporating principles of a risk-based quality management approach.



Ensure monitoring strategy is updated in response to changes of external environment and/or availability of internal data Develop, implement and follow up on robust Site Oversight Plans, in collaboration with the CTL(s) and working closely with the respective CSLs Identify and encourage use of data-driven oversight tools and methods at the site, study & program level Local/Regional Studies and Early Access Oversee Company Sponsored Studies, Collaborative Research Studies and Investigator Sponsored Studies across the portfolio in regards of set-up, conduct and delivery per applicable Governance approvals and contractural obligations – including any agreed quality and/or safety data exchange expectations (as applicable across assigned program(s)/product(s)) Act as the global operations lead for Early Access (EA) activities, partnering with Medical Affairs to co-lead a multi-functional team accountable for implementing the agreed EA strategy including vendor selection and management activities (if applicable); ensure regular status updates are shared with GMA, CTE andICS O Leadership (and beyond as required) Work closely with GMA Lead(s) to track overall progress/quality and milestone performance and ensure issues are addressed immediately in priority studies Participate in GMA/Launch/Brand Team meetings (as appropriate) to provide operational expertise and promote information sharing with the CRMs as needed Represent CTE at Governance Boards e.
G. GMDB, DSC etc,



specifically through review of CRM operational plans and providing guidance to ensuring realistic ‘fit for purpose‘ study feasibility (timelines, cost, resources) Review program level CML Dashboard and Finance Tool on a monthly basis to ensure timely risk management and mitigation Work closely with CRMs and other functions as needed to support the financial planning exercise at the program level Strategic Impact Oversee Company Sponsored Studies, Collaborative Research Studies and Investigator Sponsored Studies across the portfolio in regards of set-up, conduct and delivery per applicable Governance approvals and contractural obligations – including any agreed quality and/or safety data exchange expectations (as applicable across assigned program(s)/product(s)) Act as the general operations lead for Early Access (EA) activities, partnering with Medical Affairs to co-lead a multi-functional team accountable for implementing the agreed EA strategy including vendor selection and management activities (if applicable); ensure regular status updates are shared with GMA, CTE andICS O Leadership (and beyond as required) Work closely with GMA Lead(s) to track overall progress/quality and milestone performance and ensure issues are addressed immediately in priority studies Participate in GMA/Launch/Brand Team meetings (as appropriate) to provide operational expertise and promote information sharing with the CRMs as needed Represent CTE at Governance Boards e.
G. GMDB, DSC etc, specifically through review of CRM operational plans and providing guidance to ensuring realistic ‘fit for purpose‘ study feasibility (timelines, cost, resources) Review program level CML Dashboard and Finance Tool on a monthly basis to ensure timely risk management

📌 Trial Clinical Delivery Lead (Madrid)
🏢 ICON Strategic Solutions
📍 Madrid