Trial Clinical Delivery Lead

ICON Clinical Research; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

ICON Clinical Research in Madrid seeks a Senior Project Manager/Trial Clinical Delivery Lead to drive operational delivery of complex clinical studies in a sponsor‑dedicated model, supported by ICON’s global expertise.

You will lead cross‑functional teams across CSL/CRM and vendors, develop monitoring and start‑up strategies, and ensure risk‑based oversight across regions, including travel up to 20% where needed.

Qualifications

• Graduate degree in Medical or Life Sciences.
• 10+ years of professional, project management experience in clinical research.
• Experience leading CSL/CRM functions and remote/vendor partnerships.

Responsibilities

• Interpret analytics to improve study execution and risk-based oversight.
• Lead CSLs, CRMs and external providers; drive governance and oversight meetings.
• Design and monitor country start-up strategies and monitoring plans.
• Coordinate cross-functional teams across regions with global stakeholders.

Skills

Leadership

Stakeholder management

Analytical skills

Problem solving

Communication

Presentation skills

Travel readiness

Education

Graduate degree in Medical or Life Sciences

Job description

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 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
• 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 CSLs, CRMs, Contract/FSP staff/(TCDLs if applicable)
• Collaborate with IC SO Heads on CSL/CRM/FSP resourcing needs and performance related escalations as applicable
• Oversee external providers as applicable

Education

Requires graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent

Work Experience

• Clinical operations experience – ideally across Phases (I-IV)
• Expert knowledge of clinical development (principles and concepts as well as regulatory environment e.g. ICH GCP and applicable regional/local regulations)
• Oncology and/or Neurology and/or Immunology TA experience desired
• Substantial (10+ years) professional and project management experience in clinical research in a CRO, pharma or biotech company including site management/oversight, clinical study planning and conduct

Job Specific Competencies and Skills

• Aptitude to interpret outputs from analytical tools to enhance and improve study execution
• Comfortable working in a fast‐paced environment where speed is paramount
• Fluency in English (oral and written) plus local language
• Position may require domestic/international travel up to 20% of time
• Ability to work independently on assigned tasks or projects
• Ability to assess risk, solve problems and take decisions
• Demonstrated ability to handle and oversee multiple tasks simultaneously and to prioritize in a meaningful way
• Analytical skills, quick perception and good judgement
• Demonstrated good interpersonal skills
• Demonstrated good written and verbal communication skills Demonstrated good presentation skills
• Good cultural awareness

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What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)