Trial Preparation

Accountable for the trial activities for responsible R/OPU, including but not limited to:

• Ensure the trial is conducted in compliance with GCP‑ICH, local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.
• Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
• Appropriate trial‑specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.
• Accurate planning and co‑ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.
• Verifies and provides input into the country and site level feasibility and OPU commitment (site and patient commitment). Finalise and validate site...