Global Study Manager/Project Leader

The Global Study Manager II (GSM II) provides operational leadership throughout the study lifecycle, with accountability for oversight and execution of study management, site management, preferred Contract Research Organization (CRO), and vendor deliverables for all study management deliverables in a study.

Responsibilities

Provides operational leadership throughout the study lifecycle; Leads and coordinates the execution of a clinical trial globally; Provides quality oversight and coordination of regional and country operations and the CRO; Provides leadership to the teams in setting recruitment targets and delivery milestones; Serves as a critical member of the core team and represents the operational sub-team; Drives decision making and works closely with the Clinical Study Team Lead; Provides supervision and/or mentorship to SOMs and possibly other GSMs; Ensures development of study level plans; Approves and oversees drug supply management; Ensures overall vendor oversight; Reviews consolidated pre-trial assessment reports and feasibility outputs; Forms, oversees, and leads the operational sub team; Ensures country level feasibility is completed; Ensures Trial Master File setup; Provides input into risk planning; Coordinates development of study and protocol training and global investigator meetings; Develops and provides key inputs to clinical trial budget; Monitors budget and contracts for assigned vendors; Leads inspection readiness activities; Supports development and delivery of decentralized capabilities; Leads and oversees all elements of study startup and monitoring functions; Works proactively with data management functions; Regularly reviews data reports and dashboards; Provides operational input into protocol design; Leads protocol deviation trend review; Serves as technical expert for study management systems and processes; Champions the implementation and use of harmonized processes

Requirements

Requires exceptional knowledge of own discipline and advanced knowledge of others; Experience in clinical research and/or study management; Study management/leadership experience; Experience with oversight of CROs and vendors; Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend; Fluency in written and spoken English required; Ability to work outside of core business hours, as required, to support global trials or initiatives; Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings; Exceptional knowledge of study management processes and deliverables; Good knowledge in understanding the responsibilities beyond their function to ensure goals are met for the study; Maintains expertise within the assigned therapeutic area and study to set the appropriate strategy, identify risks and to drive operational deliverables; Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations; Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required; Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required

Nice to have

Scientific or technical degree; extensive knowledge of clinical trial methodology