Global Study Associate Director

The Global Study Associate Director (GSAD) is a business-critical role within Late Development Oncology team, whose main accountability is the delivery of clinical studies. The GSAD is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GSAD is the main liaison between the study team and the Clinical Program Team (CPT) starting with study handover through to close-out and archiving. The GSAD is accountable to the CPT for the delivery of a study according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners. The GSAD leads the study team and/or study oversight team in accordance with the Study Delivery Operating Model (SOLID), Sponsor Project Management Framework and/or clinical outsourcing model, current clinical trial regulations (e.g. ICH GCP), Sponsor Standard Operating Procedures (SOPs) and policies and best practices.

Responsabilities:

- Lead and coordinate a cross-functional study team of experts in accordance with SOLID (Study Team Operating model for Internal Delivery) and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards.
- Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan.
- For outsourced studies, be the primary sponsor point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant Sponsor SOPs and guidelines (e.g. description of services and transfer of obligations).
- Provide input into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant Sponsor SOPs.
- Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented.
- Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.) ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team.
- Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.
- Identify and report quality issues that have occurred within the study in accordance with relevant Sponsor SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.).
- Oversee Trial Master File (TMF) completion in accordance with relevant Sponsor SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times.
- Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, budget attestations, Clinical Trial Transparency).
- The GSAD is responsible for study budget re-forecasting following initial budget estimate provided by the CPT and accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process).
- Ensure studies are inspection-ready at all times, according to ICH-GCP and Sponsor SOP and relevant policies/guidelines; GSAD is the primary LDO Clinical Operations point-of
- contact in the event of an audit or inspection.
- Provide regular feedback on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues
- Work on non-drug project work such as LDO Clin Ops representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

**Profile**:

- University degree (