Sma Ii Milano

Sma Ii
Milano
Lombardia, Milano

At ICON, it's our people that set us apart.

Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point.

In short, to be the partner of choice in drug development.

That's our vision.

We're driven by it.

And we need talented people who share it.

If you're as driven as we are, join us.

You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Recognize, exemplify and adhere to ICON's values, which center on our commitment to People, Clients and Performance

- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

- Positive attitude towards their position and ICON

- Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary

- Serves as the primary contact for sites and investigators participating in studies

- Acts as a resource for internal study teams and other ICON departments

- Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others) and other site management documents

- Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan

- Participates in QA audits as needed

- Regularly attends and contributes to project specific and departmental meetings

- Assists, as needed, in developing and reviewing study documents

- Ability and willingness to travel as needed (drive and fly) - approximately 25% of the time

- Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs

- Maintains and archives study documentation and correspondence, as needed

- Assists with site contracting process, as needed

- Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed

- Assists with SAS/Steering Committee organization and attendance when applicable

- Demonstrates increasing ability to manage site assignments and workload

- Maintains Sponsor and patient confidentiality

- Actively participates in regular meetings with Project Managers or delegate, and/or RS Lead to discuss project strengths and challenges associated with recruitment, enrolment, site communications and site responsiveness

- Assumes additional responsibilities as detailed and documented by PM or delegate, RS Lead or Line Management

- Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines

- Demonstrates ability to implement the study monitoring plans/metrics as appropriate and agreed upon

- Working knowledge of and compliance with local regulatory requirements

- Compliant and current with departmental and corporate policies and procedures

COMMUNICATION

- Excellent written and oral skills while showing cultural awareness and understanding; strong presentation skills, proactive interaction with study team and site staff

- Demonstrates ability to provide and receive constructive feedback; appreciates team goals, respects others point of view and seeks advice when appropriate

BUSINESS DEVELOPMENT

- Supports and fosters relationships with internal and external customers

- May support the development of proposals for new business and attend bid defence presentations

- May attend bid defence presentations, as needed

- Supports internal and external capabilities presentations

TEAMWORK

- Participates in training and mentoring of junior staff

- Works in collaboration with internal and external colleagues to meet project objectives, timelines, and budget

- Supports and follows departmental policies and procedures

- Takes responsibility for project tasks and sees these tasks through to successful completion

- Completes special projects and miscellaneous assignments as needed to meet project and/or department objectives

- Maintains professional interpersonal relationships with team, sites, and Sponsor

PERSONAL/PROFESSIONAL DEVELOPMENT

- Continues to increase knowledge of therapeutic areas, GCP and any applicable local regulatory requirements

- Continues to seek more opportunities to demonstrate leadership and enhance own professional growth

- Actively participates in Lunch and Learns, Journal Clubs, or other internal company training sessions

- Keeps current on industry trends and regul