Senior Manager, Trial Delivery Leader
jj · Porto Salvo
Descrição do cargo
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.
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jj
Porto Salvo
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