The Director Global Study Leader 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 Global Study Leader may also provide expert input to other non-drug programs and improvement projects.
- 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 Director, may lead and deliver differentiated and robust operational options for review at Investment Decision Governance interactions
- Leads the delivery of the clinical study(s) or program(s) from concept to final CSR and through to study closed and archived to agreed budget, time, project standards, quality, and scientific standards
- Accountable for overall study or program deliverables, maintaining oversight throughout the life of the study or program by close interaction with individual study/program leaders or leadership of the study team as appropriate
- Ensure sponsor oversight throughout the life of the study
- Develops and manages effective risk management/mitigation plans to ensure timely delivery to quality, budget and time and advance issues to partners as appropriate
- Responsible for planning and leading issue escalation and resolution
- Provide input to forecasting and management of study/program delivery costs, resource and timelines
- Accountable for the quality of study/program planning information into relevant planning systems
- Mentors and supports development of individuals within the organization
- Contributes to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
- Responsible for oversight of CROs and other clinically outsourced third party vendors for outsourced studies and programs
- Responsible for study or program level reporting of progress, risks and issues
- Lead the study delivery related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
- Provision to procurement clear specifications for study or program specific outsourcing
- Review and operational approval of study or program specific contracts or work orders