Specialist, Clinical Trial Management

01 ago - Italia
ALFASIGMA

Purpose of the Job
The Specialist, Clinical Operations supports the planning, execution, and administration of clinical trials. This position is responsible for administrative and coordination tasks and will have increasing Study Team Lead (STL) accountabilities with oversight of the STL. The position offers the opportunity to increase responsibilities in clinical trial tasks and may also be responsible for additional assignments such as clinical systems development. The position requires adaptability and the capacity to ‘own’ tasks, problem solve and to see activities through to conclusion.

Principal Accountabilities
- Will interact directly with the Clinical Operations team (e.g., STLs, CBO, managers), other functional leads that are members of the Clinical Study Team, CRO and other vendors to provide support in study-specific tasks and the overall management of clinical trials.
- Will support Operational Team Leaders (OTLs) and STLs, and, as requested by the OTL or STL, other study team members. Specific responsibilities include:




- Maintain and manage data entry into AL designated study systems to fulfill study requirements and be responsible for requests for access to study systems and deactivation of system users.
- Coordinates materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings.
- Distribute relevant documents, if required.
- Maintain and update study team and vendor contact information.
- Assist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates.
- Drafting, reviewing, formatting and finalizing study-related templates, plans and manuals.
- Supporting the invoice process if required.
- Vendor management (if applicable) and tracking deliverables.
- Manage the maintenance of clinical trial insurance.
- Assist with questions, issues or requests from the CRO/study team and route to the appropriate i

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