Regulatory and Start Up Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78eq2z

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. The role may also include maintenance activities. This is a hybrid role requiring a monthly presence in Milan. Candidates should have experience with local submissions and be fluent in Italian.
Essential Functions Serve as the Single Point of Contact (SPOC) for investigative sites, Site Activation Managers (SAMs), the Project Management team, and other relevant departments under general supervision.
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), and quality of designated deliverables and project timelines.
Perform start‐up and site activation activities according to applicable regulations, SOPs, and work instructions.
Distribute completed documents to sites and internal project team members.
Prepare site regulatory documents, reviewing them for completeness and accuracy.




Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project‐specific information.
Review and provide feedback to management on site performance metrics.
Review, establish, and agree on project planning and timelines.
Ensure monitoring measures are in place and implement contingency plans as needed.
Inform team members of the completion of regulatory and contractual documents for individual sites.
Track and follow up on the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Forms (ICFs), and Investigator Pack (IP) release documents, in line with project timelines.
Provide local expertise to SAMs and the project team during initial and ongoing project timeline planning.
Perform quality control of documents provided by sites.
May have direct contact with sponsors on specific initiatives.
Qualifications Bachelor's Degree in life sc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78eq2z