Regulatory And Start Up Specialist (Rsus) (Fsp) Milano

Regulatory And Start Up Specialist (Rsus) (Fsp)
Milano
Lombardia, Milano

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.

May also include maintenance activities.

**Essential Functions

- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.

- Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), 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 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 project timelines.

Ensure monitoring measures are in place and implement contingency plan as needed.

- Inform team members of completion of regulatory and contractual documents for individual sites.

- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

- Perform quality control of documents provided by sites.

- May have direct contact with sponsors on specific initiatives.

**Qualifications

**Bachelor's Degree Bachelor's Degree in life sciences or a related field.

**3 years clinical research experience, ** including 1 year experience in a leadership capacity.

Equivalent combination of education, training and experience.

In-depth knowledge of clinical systems, procedures, and corporate standards.

**Italian fluent