Sponsor Dedicated Sr Site Activation Specialist (1 Year Fixed Term) - Home Based Ita Milano

Sponsor Dedicated Sr Site Activation Specialist (1 Year Fixed Term) - Home Based Ita
Milano
Lombardia, Milano

Sponsor Dedicated Sr Site Activation Specialist (1 Year fixed term) - Home Based ITA Updated: January 3, 2025

Location: Italy-Europe - ITA-Home-Based

Job ID: 24007104

Sponsor Dedicated Senior Site Activation Specialist (1 Year Fixed Term) - Home based ITA Previous experience with Gene therapy studies is required.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.

We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture – where you can authentically be yourself.

We are continuously building the company we all want to work for and our customers want to work with.

Job responsibilities Responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with minimal oversight from the SSU Country Manager.

Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU tracking system in real time.

Monitors financial aspects of the project and the number of hours/tasks available per contract.

Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner.

Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned.

Responsible for one or more of the following functions at the country level:

Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SAL.

May serve as the primary point of contact for the PM/SAL during start-up on allocated projects.

Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA.

May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.

Qualifications Bachelor's Degree Excellent understanding of clinical trial process across Phases II-IV and ICH GCP Good understanding clinical protocols and associated study specifications Excellent understanding of clinical trial start-up processes Project management experience in a fast-paced environment Strong organizational skills with proven ability to handle multiple projects Excellent communication, presentation and interpersonal skills Quality-driven in all managed activities Strong problem-solving skills Ability to mentor, lead and motivate more junior staff Additional Information:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.

The Company may assign other tasks, duties, and job responsibilities at its discretion.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.

If your past experience doesn't align perfectly, we encourage you to apply anyway.

Syneos Health is an Equal Opportunity Employer.

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