Oversee one or more concurrent clinical studies. Represent the clinical development operations function on the clinical trial team. Lead and coordinate study management meetings.
Manage and provide day-to-day oversight of full service CRO, third-party-vendors, contract monitors; including set-up, logistics, documentation, and clinical supplies needed for clinical trials.
Manage trial budgets and timelines. Forecast external trial resource needs; accountable for the trial level clinical operations budget, management and tracking of trial budget in conjunction with CRO and contract manager. Contribute to developing SOWs, site budgets, CTAs, etc.
Independently manage interactions with and between clinical monitors, data management, biostatistics, medical writing, safety, regulatory affairs, and pharmaceutical science and QA team members, both internally and externally.