Study Delivery Lead, Clinical Operations

The Study Delivery Lead (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability for 1 or several complex studies in various settings including Phase I-III, within a delivery model comprising of outsourced studies or outsourced studies with elements of insourcing. This includes global operational execution and delivery of clinical studies across multiple geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Health Authority regulations, International Conference on Harmonization (ICH) guidelines and local regulations, as required. The SDL is accountable for operational planning and execution at the study level with responsibility for clinical study plans and execution (from planning start-up, conduct, reporting and close out) including timeline, and budget. The SDL will partner with the Strategic Vendor Oversight (SVO) team and collaborate with the core and extended team to ensure robust CRO oversight including 3rd party vendors to achieve study milestones and deliverables according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The SDL collaborates with cross-functional stakeholders and the Metrics, Analytics, Reporting and Solutions (MARS) team to drive and monitor progress. The SDL fosters an environment where the core study team maximizes their expertise and contribution to trial delivery, including but not limited to issue resolution, risk mitigation and escalation to Global Project Team (GPT), SCORE and other governance level as needed The SDL will have regular interactions with key internal and external stakeholders to discuss project status, escalate issues, and troubleshoot inquiries. For this role, strong written and verbal communication skills in English, operational leadership, and decision-making, ability to delegate, strategic thinking, conflict resolution, clinical project management experience and attention to detail are required. The SDL is an experience matrix leader and serves as a mentor to more junior colleagues on clinical trial execution. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations. The SDL is the reference and role model within the study delivery lead team that drives the culture for a healthy team. The role is primarily responsible for Operational Study Strategy and Study Execution while exhibiting leadership qualities.

- -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 - Protocol Development, and Team Assembly
-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)

• Study Conduct and Oversight
-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. • Quality and inspection readiness
-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.

Education Qualifications
Bachelor's Degree In Life Sciences field and a minimum of 7 years relevant experience required

Experience Qualifications
Experience in global clinical operations methods and processes in industry setting is required required
Experience considered relevant includes clinical or basic research in a pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), hospital/medical setting or Contract Research Organization (CRO). Clinical Project Management experience required. required
CRA experience is preferred preferred
Familiarity with a Japan-based organization is beneficial preferred


Travel Requirements
Ability to travel up to 10% of the time.