TheProject Manager is a member of the Project Team and has overall responsibility and accountability for the execution of the clinical operations strategy of the project. The PM is responsible for coordinating and managing the clinical operations and local site services maintenance team, providing leadership and expertise to ensure successful execution of the site selection, clinical operations and IRB/IEC/regulatory maintenance project deliverables (quality, timeline, budget and scope).

This role requires collaboration within a matrix environment, proactive internal/external communication, and exceptional strategic planning, risk management and organizational skills.

As a Project Manager your main responsibilities will be:


Technical-scientific support within the process of draft, revision and implementation of research protocols of RWE studies based on secondary data collection of the Sponsor, pursuant of the terms of the applicable legislation;

Support to the Study Teams (and ad hoc members according to the specific project needs e.g. Affiliates, other departments representatives), with the preparation of documents for submission to the Ethics Committees, Regulatory Authorities and National applicable Authorities, pursuant to the terms of the applicable legislation;

Support to the Study Teams in the selection, verification and supervision of the CRO and other providers (related to activation, management and performance monitoring), pursuant to the terms of the legislation GCP, GVP and local legislation applicable.

Development and optimization of document templates appropriate for RWE studies with secondary data collection.

Participation and coordination of regular and periodic meetings with the Study Teams and the CRO (or other suppliers) to be carried out with sponsor's staff, in order to monitor the performance and respect of timelines of the contracted activities in line with the regulatory requirements;

Responsible for electronic TMF set-up and maintenance during the study, oversight of filing documentation completeness, through ongoing quality checks and metrics, oversight of CRO filing activities in the eTMF and will be responsible for eTMF reconciliation after study completion.

Checks monthly costs invoiced to the sponsor based on planned study activities vs actual

Education/Qualifications:

• University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
• Fluency in English & local language.
• Happy to commute once per week to Parma

Experience:

• + 1 year of experience managing Clinical Trials in Real World Solutions