20 set - Latina
NOUSCOM
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.
Le seguenti informazioni hanno lo scopo di fornire ai potenziali candidati una migliore comprensione dei requisiti per questo ruolo.
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 su
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