Sma Ii

The Site Management Associate II (SMA II) is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations

**What you will be doing**:

- 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 regulations

LEADERSHIP
- Highly self-motivated, strong organizational abilities for multi-tasking
- Supports the LPOR management activities and initiatives
- Supports the development and maintenance of practice-specific process documents (e.g., SOPs and Best Practice Guidelines)
- Supports team compliance with all relevant SOPs and Best Practice Guidelines

MANAGERIAL/ ADMINISTRATIVE
- Helps to ensure project activities are consistent with project requirements and scope
- Practices good time management, with support

ADAPTABILITY
- Demonstrates flexibility working across different time-zones and working with internal and external teams
- Able to adapt to changes in deadlines, competing project demands and changes in the nature of assignments
- Ability to work independently with mínimal direction; successfully handles increasingly complex tasks/assignments

PROBLEM SOLVING
- Demonstrates resourcefulness, makes appropriate use of available technology and tools in seeking and implementing solutions
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