The Key Responsibilities for this role include, but are not limited to
Responsibility for the delivery and quality of clinical studies from protocol concept to final study report, and for the validity of all data originating from their studies.
Responsibility for reviewing the technical and scientific robustness of clinical plans and studies developed by the key customers for their designated area. Ensure development, review, finalisation and delivery of high quality key clinical study documents in order to meet study timelines.
Managing global feasibility, and in collaboration with the Clinical Development Director, determine global study allocation to appropriate countries and sites, ensuring efficient use of resources and adherence to company policies and strategic initiatives.
Working with partners to manage study level budgets
Ensuring set up and maintenance of all systems in order to plan and implement the study and track progress.
Ensuring appropriate clinical trial supply strategy is implemented and managed.
Developing the study recruitment plan, manage risk, monitor progress, and implement contingencies as required.
Ensuring efficient streamlined processes are in place to deliver study to plan and ensure safety of patients and completeness/integrity of data
Ensuring monitoring and site personnel are familiar with all study-specific processes, procedures and systems and that training is adequately documented.
Ensuring continuous direct contact with in-country personnel to provide ongoing operational support.
Responsibility for instream maintenance of the electronic trial master file