Associate Director, Global Clinical Operations
Daiichi Sankyo
- USA
- Permanent
- Full-time
- Study Management and Leadership
Provide operational input into study protocol profiles, final protocols and amendmentsLead document review and coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.Lead the creation of the CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, 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.
Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader.Ensure adherence to internal procedures for study planning, study conduct, close out and reporting.
Proactively assess potential risks to the study and propose mitigation plans.
Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader. Review and approve Vendor invoices, including investigator grants and pass through costs.Ensure study budget is reconciled with Finance on an ongoing basis.Support all inspection readiness and quality initiatives pertaining to assigned stud(ies).
Ensures trial master file is complete and accurate for assigned stud(ies).
If assigned, Associate Director, Clinical Operations may act as the Study Team Leader for the assigned clinical study and responsible for leading the cross-functional study team, project managing and coordinating with internal stakeholders to ensure cross functional integration and delivery of study team plan and milestones (e.g. protocol, eCRF/EDC, IXRS, Clinical Study Oversight Plan etc.). The study team leader will ensure meeting logistics, agenda and minutes are in accordance with DS standards. * CRO, 3rd Party Vendor Management and OversightResponsible for the oversight, performance and management of CROs and 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. Specifically track operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions.
Responsible for ensuring that the Clinical CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc.) as per study plan.Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training. Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc.).Review CRO-generated reports such as monitoring visit reports, protocol deviation reports, and analysis of site metric reports. Identify areas of concern and either resolve, propose solutions, or bring to the attention of the operations lead of study team lead. Coordinate and liaise with Daiichi Sankyo QA on site audit and inspection activities.
Conduct and/or oversee the CRO oversight monitoring visits (CROOM visits) as outlined in the CSOP.
Coordinate all operational activities under the guidance of the study team leader and liaise with CRO to support interim analysis, database lock and review of TLG before and after database lock.Oversee CRO study close-out activities (including but not limited to TMF reconciliation) and liaise with internal Functions within the study team to ensure drug destruction process and other study close out activities are completed. * Knowledge Management/People ManagementThis position may require the supervision of direct reports. In addition to providing instruction, direction of daily activities in support of goals, the supervisor will:
- Manage all employee-related activities throughout the year, including performance management and development.
- Identify and communicate the skills, behaviors and experiences required to develop employees.
- Set goals, reviews performance and provides feedback on a regular basis.
- Assist or Lead training SOPs, GCPs, operational systems, etc.
- Bachelor's Degree in a Life Sciences field and a minimum of 7 years of relevant experience. required
- Experience in clinical operations methods and processes in industry setting. required
- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred
- Familiarity to a Japan-based organization is desirable.