O SEU PRÓXIMO CAPÍTULO
Clinical Delivery Lead
Sobre a vaga
• 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
• 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
• 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