The Director Study Leader, Early Oncology Clinical is responsible for delivering a single or several smaller development programs or leading multiple studies or single complex/novel studies such as platform, basket, etc.
The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility and autonomy is required.
The Director Study Leader may provide expert input to other non-drug programs and improvement projects.Typical Accountabilities: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 documents.With oversight from the Senior Director Clinical Programs, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions.Leads 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 standards.Accountable for overall study or program deliverables, maintaining oversight by close interaction with individual study leaders or leadership of the study team as appropriate.Implements agreed study level process and technology for Early Oncology clinical studies.Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget, and time and escalates issues to stakeholders as appropriate.Responsible for planning and leading issue escalation and resolution.Provides input to forecasting and management of study delivery costs, resource, and timelines.Accountable for the quality of study planning information into relevant planning systems (e.g., IMPACT, PLANIT).Guides the study team in the development of outsourcing specifications and vendor selection.Provides procurement with clear specifications for study or program specific outsourcing.Reviews and operationally approves study or program specific contracts or work orders.Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs.Communicates study level reports and status updates for Early Oncology clinical studies.Leads and conducts investigator meetings and other study-related meetings.Identifies and communicates resource gaps for assigned studies.Leads risk management and quality efforts to ensure study compliance and continual inspection readiness.Leads the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.Mentors and supports the development of individuals within the organization.Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers, and external collaborators.
#J-18808-Ljbffr