Lead the global matrix CTT to ensure all trial deliverables are met according to timelines, budget, quality standards & procedures.Provide risk management plans and contingency plans for assigned trials.Ensure drug supply management including import/export, labelling, expiration date tracking and timely resupply for global/ local trials.
Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs (CRO project manager & BD manager).Accountable for meeting key milestone dates for the trial, enrollment rate and delivery of timely and high quality data from the trial.
Accountable for accuracy of trial information in all trial databases such as Clinicaltrials.gov and like.Accountable for development and accuracy of trial specific documents (e.g. CRFs, outsourcing specifications, monitoring and data management plans).
Deadline: Contact employer