Overview:
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
Responsibilities:
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
* Supports the Research Services Department by applying critical thinking about the business needs of a study and/or Site Management activities
* 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 minimal direction; successfully handles increasingly complex tasks/assignments
PROBLEM SOLVING
* Demonstrates resourcefulness, makes appropriate use of available technology and tools in seeking and implementing solutions
* Works well with other individuals and departments to solve problems; anticipates problems and seeks solutions proactively
Qualifications:
You are:
* Knowledge
* Proficient in the use of computer and software such as MS WORD, Excel, Power Point, etc.
* Good verbal and written communication skills (English and regional)
* Attention to detail and ability to multi-task
* Good organizational, record retention and time management skills
Key competencies
* Attention to detail
* Delivery focus
* Team work
* Time management
* Policy, process and procedural conformance
Basic qualifications
* Associate's degree or higher education
* Advanced English
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs
* Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
* Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential fun
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