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Senior Manager, Trial Delivery Leader

jj · Porto Salvo

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Senior 🇬🇧 English

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About the role

The Senior Manager, Trial Delivery Leader (TDL) is accountable for clinical trial delivery and provides operational oversight of cross-functional deliverables. The TDL leads a cross-functional trial team to build and deliver the trial operational plan, identifying and mitigating risks so that assigned trials are delivered on time, on budget and in compliance.

Key responsibilities

  • Lead the Cross Functional Trial Team to execute the operational plan and oversee end-to-end trial execution.
  • Own trial delivery, budget, timelines, quality and milestones, including supporting DBL/CSR/TLR planning and defining protocol deviation resolution pathways.
  • Proactively ensure deliverables and milestones are met, identify risks and ensure mitigation and contingency plans are followed through.
  • Ensure compliance with global health authority regulations, internal procedures and processes, and escalate concerns to the CT or CDT.
  • Take part in Health Authority inspections and internal QA audits, keeping the trial team ready for inspection.
  • Participate in process improvement at trial, compound and cross-DU levels.
  • Mentor and support onboarding of new team members, especially in Trial Management, and foster engagement and inclusion.

Required profile

  • BS degree or equivalent; life sciences fields preferred.
  • Minimum 8 years of experience in pharmaceutical, healthcare or related industries.
  • Experience leading multiple aspects of a global clinical trial (2-3 years).
  • Preferred: experience in pharmaceutical, biopharmaceutical or biotechnology.

Required skills

  • Knowledge of the pharmaceutical development process and clinical research operations across Phase I-IV studies.
  • Leadership, decision-making, analytical and financial management skills.
  • Project planning, management, communication and presentation skills.
  • Ability to lead without authority in multi-functional, matrixed and global environments, and to mentor others.

Questions fréquentes

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Expira em 1 mês

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jj

Porto Salvo