Trial Clinical Delivery Lead

About the role

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.

• Accountable for the delivery and quality of Phase I-IV, Epidemiology and Real World Evidence Company Sponsored Studies; Collaborative Research Studies; Investigator Sponsored Studies, Early Access Programs and other reseach activities [as applicable across assigned program(s)/product(s)]
• Provide leadership, strategic direction and operational oversight for Clinical Site Lead (CSL) and/or Clinical Research Manager (CRM) activities across assigned program(s)/ study(ies) in response to quality and performance oversight measures and trends
• Serve as the operational delivery expert for the program(s)/study(ies) and promote data-driven, realistic planning at the site and study level. Drive delivery-focussed accountability and ownership amongst key external (CRO) and internal partners as appropriate e.g. CSLs, CRMs, Clinical Trial Leads (CTLs), Clinical Operation Leads (COLs), Early Project Leads (EPLs), GMA Lead(s) etc
• Facilitate identification and implementation of operational excellence strategies across program(s)/study(ies) - leveraging expertise within Clinical Trial Execution (CTE) and other partner functions
• Identify trends and issues across assigned program(s)/study(ies) which may impact key study deliverables (e.g. timelines/quality/costs) and work with CSLs, CRMs, CTLs, COLs, EPLs, GMA Lead(s) and other relevant business partners to implement action plans to resolve and/or mitigate
• Drive proactive risk-based site oversight/study management practices and quality risk oversight and management across all stages of study delivery
• Ensure timely and appropriate escalation of trends, issues and risks within the Clinical Operations Team/Study Team/ Global Medical Affairs Team, department Leadership Team and/or senior management as appropriate
• Promote solution-orientated thinking and issue resolution at the country/study/program team level. Provide an escalation pathway to ensure program/study-specific major observations from CSLs/CRMs are relayed to and followed up by the appropriate internal and/or external business partners
• Support program/product/study-specific onboarding for new ICSO team members and contribute to enhancing their site/study management capabilities/skills
• Promote product knowledge, collaboration and information channelling; contribute to best practice guidance to drive consistency in the management of sites/studies
• Provide link between CSLs/CRMs and Global functions, being single point of contact for operational topics and escalations, support information channeling and facilitating solutions at the program level
• Lead regular calls with CSLs/CRMs working on study and/or other activities within the assigned program(s)
• Participate in Investigator/Study Coordinator Meetings and promote information sharing with the CSLs/CRMs as needed
• Act as functional lead for process improvement initiatives
• Other accountabilities as assigned by Functional Manager in support of the business

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 and ICSO 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 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 and ICSO 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
• Handles sensitive issues and guides, influences, and convinces colleagues in other teams/functions as well as external partners
• Identifies opportunities for creativity and innovation to reduce timelines and/or cost to deliver studies/projects

Scope of Responsibilty

• Provide functional leadership for