Clinical Delivery Lead
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Job Description
Trial Clinical Delivery Lead overseeing risk-based delivery of multinational clinical studies for ICON’s sponsor-dedicated pharmaceutical programs. Leading site operations, quality oversight, Early Access, and cross-functional teams.
Responsibilities:
- Accountable for delivery and quality of Phase I-IV, Epidemiology, Real World Evidence, Company Sponsored, Collaborative Research, Investigator Sponsored, Early Access, and other research activities
- Provide leadership, strategic direction, and operational oversight for Clinical Site Lead and/or Clinical Research Manager activities
- Serve as operational delivery expert and promote data-driven planning at site and study level
- Drive accountability and ownership among internal and external partners
- Identify and implement operational excellence strategies
- Identify trends, issues, and risks affecting study timelines, quality, and costs, and implement mitigation plans
- Drive risk-based site oversight, study management, and quality risk management
- Escalate trends, issues, and risks to appropriate teams and senior management
- Promote solution-oriented thinking and issue resolution at country, study, and program levels
- Support onboarding and enhance site/study management capabilities of new team members
- Promote product knowledge, collaboration, information sharing, and best-practice guidance
- Act as the operational link between Clinical Site Leads/Clinical Research Managers and global functions
- Lead regular calls and participate in investigator/study coordinator meetings
- Lead process improvement initiatives
- Use site performance and quality analytics to drive risk-based sponsor oversight
- Represent the Clinical Site Lead group at Clinical Operations/Trial Team meetings
- Assess country and site selection proposals and inform teams of decisions
- Design country start-up strategies and oversee site/country delivery
- Establish and update monitoring strategies based on identified risks and available data
- Develop, implement, and follow up on Site Oversight Plans
- Oversee sponsored and collaborative studies across setup, conduct, and delivery
- Act as global operations lead for Early Access activities and co-lead multifunctional teams with Medical Affairs
- Track progress, quality, milestones, and financial risks at program level
- Represent Clinical Trial Execution at governance boards
- Support program-level financial planning
- Provide functional leadership for Clinical Site Leads, Clinical Research Managers, Contract/FSP staff, and TCDLs as applicable
- Collaborate on resourcing and performance-related escalations
- Oversee external providers and drive innovation to reduce study timelines and costs
Requirements:
- Graduate background (Medical or Life Sciences degree) in a clinical research related discipline or equivalent
- Clinical operations experience, ideally across Phases I-IV
- Expert knowledge of clinical development principles, concepts, ICH GCP, and applicable regional/local regulations
- Oncology and/or Neurology and/or Immunology therapeutic area 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
- Aptitude to interpret outputs from analytical tools to enhance and improve study execution
- Fluency in English (oral and written) plus local language
- Ability to work independently on assigned tasks or projects
- Ability to assess risk, solve problems and make decisions
- Ability to handle and oversee multiple tasks simultaneously and prioritize effectively
- Analytical skills, quick perception and good judgement
- Good interpersonal skills
- Good written and verbal communication skills
- Good presentation skills
- Good cultural awareness
- Legal right to work in the country where the role is based
Benefits:
- 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
- Domestic/international travel opportunity up to 20% of time
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