Clinical Trial Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7txwpe

Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Our proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and is clinically demonstrated to safely and potently harness the power of the immune system. La descrizione completa del lavoro illustra tutte le competenze, l'esperienza pregressa e le qualifiche che i candidati dovrebbero possedere. We are looking for a Clinical Trial Manger.

The Clinical Trial Manager:

Directs and/or supports the planning and conduct of a clinical trial phase I to III, in-house and outsourced to a Contract Research Organization (CRO) in compliance with company processes, ICH-GCP and regulatory requirements;

Participates/directs CRO management and vendor oversight of outsourced activities;

Coordinates and participates in co-monitoring of clinical trials;

Performs assigned responsibilities to ensure timely achievement of departmental goals and objectives related to clinical trials.

Responsibilities





Participates in the CRO selection process and periodic CRO/vendor performance assessment

Contributes to development of clinical study protocols, trial budgets and project plans

Contributes to country and site selection for clinical trials

Assists in planning and operational execution of clinical trial supply needs

Takes responsibility in maintenance of clinical trial registries and related databases

Serves as point of contact to CRO and vendors

Maintains a strong knowledge of the protocoland study procedures

Reviews and prepares study plans and manuals (Patient Information Sheet and Informed Consent Form, Project Plan, Monitoring Plan, Communication Plan, Pharmacy Manual, Investigator Site File, etc.) Approves country/site PIS/ICF prepared by CRO and oversees timely PIS/ICF implementation on site level

Develops and implements Vendor Oversight Management Plan (VOMP) Leads and/or supp

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7txwpe