Associate Director, Study Delivery Lead - Global Clinical Operations - Phase I Oncology

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Requirements:

• Experience in global clinical operations methods and processes in industry setting is required
• Clinical Project Management experience required
• Strong Global Oncology therapeutic area experience required

Responsibilities:

• Lead the core study team while project managing and collaborating with internal stakeholders to ensure cross functional integration and delivery of study milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.)
• Ensure operational study-level timeline, budget, deliverables and quality management
• Facilitate escalation and resolution of issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP. The SDL is accountable for escalation to the OPL/Asset Lead (or Senior Line Leaders in the absence of Asset Lead).
• Where appropriate, may delegate certain responsibilities to Study Manager(s) assigned to the study
• Contribute to and interface with different levels of study governance, as required
• Oversee the development of the clinical study plan including critical path activities and interdependencies for assigned clinical stud(ies)
• Provide operational input into concepts, CDP, study protocol profiles, final protocols and amendments
• Participate in protocol and amendment review. Contribute to the development of and oversee delivery timelines of ICF, IB and safety communications, DSUR, IND.
• Partner with other functional leaders to address core study team gaps and ensures accurate and complete study team list is maintained.
• In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination and conduct of feasibility process for protocol development in alignment with the CDP/IEP.
• Application of feasibility analysis to manage study implementation in the clinical and regulatory environment across participating regions, provide quality data and ensure timely study delivery
• Lead the CRO and vendor selection process and scope of work in collaboration with the study team and Procurement Management.
• Lead trial feasibility and site identification and qualification activities in collaboration with the CRO, feasibility team and the study team.
• Assist Data Management with development of the clinical database (edit checks, CCG development, and UAT)
• Ensure operational adherence to the clinical study oversight plan
• Reinforce CRO/Vendor accountability for trial execution and quality data delivery. Foster a culture of empowerment and accountability for CRO to resolve study issues internally, raising such for DS action per exception/defined criteria for escalation
• Monitor clinical trial performance and quality metrics and share with study team and GPT on regular basis and ensure actions are taken (at the study team level and CRO and vendors levels) and/or issues / risks are escalated to project team level and relevant governance bodies
• Lead escalation and resolution of issues with CRO/ vendors/ site/ country performance including serious quality incidents and serious breaches of GCP. Triage, resolve or escalate study issues /risk mitigations as per JOC/ESC and other established forums. The SDL is accountable for escalation to the Asset Lead (or Senior Line Leaders in the absence of Asset Lead).
• Monitor study budget against trial progress and Inform Finance of deviations
• Review and approve Vendor invoices, including investigator grants and pass through costs.
• Support inspection readiness and quality initiatives pertaining to assigned study(ies).
• Serve as primary SME engaged in dialogue with inspector(s) to address study inquiries throughout course of HA inspection
• Ensure trial master file is complete and accurate for assigned stud(ies).
• Ensure that a study level operational risk management plan is in-place and applies a smart-risk taking philosophy
• Responsible for the delivery, oversight, performance and management of 3rd party vendors to ensure compliance with Daiichi Sankyo’s quality measures and adherence to scope of work within timelines and budget at a task level.