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 integral 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

📌 Trial Clinical Delivery Lead (España)
🏢 Icon Clinical Research
📍 España