Clinical Trial Manager - maternity cover

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b3ygd

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. We are looking for a Clinical Trial Manger for a maternity cover.

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. 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 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)



Conducts co-monitoring visits and reviews monitoring visit reports Develops study status trackers and reports Provides updates of study status to supervisor and senior management Performs periodic review of protocol deviations, risks and issues to identifytrends, quality/compliance concerns or any other areas for improvement and initiates appropriate actions with CRO/vendor and as required in cooperation with CTL and/or Quality Assurance Participates in performance assessments, audits and Health Authority inspections Facilitates resolution of trial related issues through communication with site personnel and/or clinical trial vendors, including central labs, monitoring CROs Support set-up of relevant systems for clinical trials such as EDC, IRT, eTMF, RACT, etc. Maintains knowledge of regulations, guidelines, policies and practices for clinical trials Participates in periodic review and development of corporate/departmental SOPs and policies Bachelor’s degree or equivalent qualification in life science/healthcare (Master’s degree is preferred) ~5 years of progressively increasing clinical research experience within the pharmaceutical/CRO industry preferably in clinical operations in oncology ~ Monitoring experience in oncology clinical trials ~ Experience in management of clinical trials ~ Experience with health authority inspections (FDA and/or EMA) preferred Thorough knowledge of drug development regulations (ICH-GCP, FDA, EMA and local regulations) Working experience in a global team, team player Good organizational and time management skills Good communication skills Fluent in spoken and written English As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b3ygd