05 ago
|
Experteer Italy
|
Cusano
05 ago
Experteer Italy
Cusano
Experteer Overview
As Trial Delivery Leader, you own trial operational strategy, budget, quality, and on‑time delivery across assigned trials. You partner with the PDL and co‑lead the Cross‑Functional Trial Team to align trial plans with program objectives and optimize delivery. You balance speed, cost, and innovation while ensuring compliance and inspection readiness. This role combines strategic leadership with end‑to‑end execution to drive impactful trial outcomes.
Retribuzione / Benefits
- Develop and harmonize the trial operational strategy with all functional strategies, including vendor management.
- Co‑lead the CFTT, setting cadence, agendas, and expectations; empower team members to deliver while maintaining accountability.
- Own trial‑level on‑time delivery, quality, and budget; ensure milestones and targets are met.
- Oversee trial‑level budgeting, scenario planning, and cost optimization.
- Review key study documents (e.g., global master ICFs) and ensure quality and compliance.
- Identify, assess, and mitigate trial‑level risks through closure; manage escalations with vendors and enrollment risks.
- Define protocol deviation pathways and align on resolution processes.
- Represent GD in TA governance forums and ensure operational feasibility of decisions.
- Coordinate with PDL on protocol amendments and enrollment targets; ensure TMF and study documentation are inspection‑ready.
- Set up and oversee trial systems and documentation (e.g., TMF, CTMS, E7 drivers).
Responsabilità
- Bachelor in Life Sciences or equivalent.
- 6–8 years in clinical trial management in pharma or CRO.
- End‑to‑end trial delivery experience.
- Strong knowledge of ICH‑GCP, regulatory requirements.
- Proven leadership and ability to guide cross‑functional teams.
- Experience coordinating global/regional teams in a virtual environment (2–3+ years).
- Excellent communication and presentation skills.
- Strong project planning and risk management abilities.
- IT skills with TMF and CTMS familiarity. xysqume
- Willingness to travel; English and local language proficiency.
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📌 Global Trial Delivery Lead - Sponsor Dedicated (Cusano)
🏢 Experteer Italy
📍 Cusano