Job Description:

Preferred work locations are Gaithersburg, Maryland or Wilmington, Delaware (Hybrid)Provides expert clinical operational input into project or study level documents, for example clinical development plan, clinical study protocol, clinical study report, and may lead the delivery of study documentsWith oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactionsLeads the delivery of the clinical study program(s) or study(s) from concept to final CSR and through to study closure and archive to agreed budget, time, project standards, quality and scientific standardsAccountable for overall study or program deliverables, maintaining oversight by close interaction with individual study leaders or leadership of the study team as appropriateImplement agreed study level process and technology for Early Oncology clinical studiesDevelops and manages effective risk managementmitigation plans to ensure timely delivery to quality, budget and time and escalate issues to stakeholders as appropriateResponsible for planning and leading issue escalation and resolutionProvide input to forecasting and management of study delivery costs, resource and timelinesAccountable for the quality of study planning information into relevant planning systems (e.g.: IMPACT, PLANIT)Guide the study team in the development of outsourcing specifications and vendor selectionProvision to procurement clear specifications for study or program specific outsourcingReview and operational approval of study or program specific contracts or work ordersResponsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programsCommunicate study level reports and status updates for Early Oncology clinical studiesLead and conduct investigator meetings and other study related meetingsIdentify and communicate resource gaps for assigned studiesLead risk management and quality efforts to ensure study compliance and continual inspection readinessLead the study delivery related activities associated with regulatory inspectionsaudits in liaison with Clinical Quality AssuranceMentors and supports development of individuals within the organizationContributes to operational interactions with external entities including regulatory agencies, preferred partnerssuppliers and external collaborators