Senior Clinical Project Manager (Remote)
Company: CliniRx | Location: Spain
Role Summary: CliniRx is seeking an experienced, independent and driven Clinical Trial Project Manager to successfully manage and deliver assigned clinical studies within timelines and budgets in compliance with Good Clinical Practices, and all Global, National and Local Regulations. The candidate will be responsible for the overall planning, coordination, implementation, and execution of end-to-end clinical trials from protocol development through study conduct and close out. Reporting to the Project Director, the Clinical Trial Project Manager will also serve as a mentor to Associate Project Managers, Team Leads, and Clinical Research Associates.
Responsibilities: Be responsible for project planning, implementation, control, and evaluation for multiple studies with limited supervision.
Develop study timeline in consultation and collaboration with the cross-functional team.
Coordinate and manage clinical study project activities and team in a manner that ensures all study timelines, quality parameters, and budgetary requirements are met.
Lead the development of global study-level documentation and the setup of the required tools and systems as per the requirements of the assigned studies.
Lead development, implementation, and supervision of global Drug Supply Plan to ensure IP availability at the right place and the right time to support study needs.
Design training requirements of the internal team and external team and vendors including, but not limited to, investigator meetings and supervise the implementation till closure.
Ensure regulations are being implemented according to ICH GCP and applicable SOPs.
Continuously monitor study quality and implement the required standards in order to meet compliance requirements.
Perform financial management, including review and approval of site and vendor invoices.
Oversee study supplies through their management cycle (requirements set up till used/discarded).
Responsible for biological sample management, coordinate trial-related materials, including clinical trial supplies.
Plan, organize and manage internal team and client-specific meetings at the prescribed timelines.
Timely prepare and submit project status reports for senior management and sponsor.
Lead and coordinate the cross-functional team (Clinical Operations, Biometrics, Regulatory, Safety Medical Affairs, Finance and Legal) for the timely delivery of the contracted services according to CliniRx and sponsor standards.
Manage relationships with Sites/PIs and other study-related vendors such as Central Labs, IVRS, Technology Partners, etc.
Lead the identification, management and escalation of risks either alone or in collaboration with the cross-functional team.
Participate in the development, review and implementation of departmental SOPs and processes.
Support the preparation of Proposals, study Budgets and Timelines and Scope of Work/Service Agreements.
#J-18808-Ljbffr
