Site Manager

24 ore fa

Roma, Italia Hobson Prior A tempo pieno

Hobson Prior are looking for a Site Manager to join a brilliant pharmaceutical organisation on a permanent basis located in Rome. Our client is focused on forming a healthier society all around the world.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For the position of Site Manager, you will hold accountability over instigating study compliance by implementing activities within site initiation and start-up, site monitoring, site management and site/study close-out corresponding to internal SOPs/WIs/IFUs and policies. Warrant site staff is trained, and the matching training records are complete and precise at any time point during all trial phases.
- Guarantee site is equipped to carry out the trial with acceptable site study supplies (such as Non-IP, lab kits, etc.) and clinical drug supplies. This will involve supervision of proper handling, storage and return and/or demolition with precise inventory maintained/documented.
- You will conform with pertinent training obligations.
- Partake in quality Site Selection through contribution in site feasibility and/or pre-trial site evaluation visits, offering recommendation from local area about site/investigator selection in collaboration with the trial team, as needed.
- Assure quality data (accurate, valid and complete) is presented by the site and doubts resolved within expected timelines.
- Collaborate with LTM to ensure CAPA is completed for QA site audits and for quality matters recognised at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
- If pertinent, the Site Manager will support negotiation of investigator budgets at site level, support tracking of costs and certify payments are made at site level, maintaining site relationships.
- You might have the responsibility to participate in the HA and IEC/IRB submission and notification processes as needed /suitable.
- Any other assigned duties.

**Key Skills**:

- Functioning communication skills, oral and written.
- Robust IT skills in fitting software and company systems.

**Requirements**:

- At least 2 years of clinical trial monitoring experience or corresponding industry experience and accomplishment of a monitoring training course.
- Detailed therapeutic area experience depending on the services need.
- Solid working knowledge of ICH GCP, company standard operating procedures, local laws and regulations, allotted protocols and related protocol specific procedures including monitoring guidelines.
- You are willing to travel with overnight stays away from home according to business requirements.
- Practised in speaking and writing in English and the country language where services will be delivered.
- Prior experience with monitoring and site management of multifaceted Early Phase of clinical development, as valid.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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