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As Site Management Associate I (SMA I), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes.
You will be engaged in a wide range of interesting and challenging tasks.
You will be partnering with one of the worlds premier Biopharmaceutical companies.
Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally.
What you will be doing:
Key Responsibilities:
-Setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed.
Granting access to new system users.
-Supporting study lead in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination).
-Support in managing the study team's communication: meetings (preparation, scheduling, meeting minutes), info-spaces, newsletters, action logs, communication plans, team lists etc.
-Coordination of the study budget -managing expenses, tracking updates, checking consistency between systems and agreements and escalating issues.
-Providing input to develop study specific processes and procedures, adhering to standardization and dissemination of best practices.
Depending on experience/expertise:
-May be involved in preparation and updating of study documents and study plans, including, Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plans, Risk Management Plans, Communication Plans etc.
-May act as Local Operating Companies liaison / oversight - including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies' availability, regulatory approvals and import license status
-May be involved in Vendor management & CRO oversight - agreeing on study-specific setup requirements, ensuring continued monitoring of agreed delegated activities
-May contribute to Risk management - contribution to maintenance of a comprehensive risk management plan and risk tracking
-May be involved in clinical supplies and recruitment materials management - having oversight on study level supplies availability, recognizing and communicating issues to continuity of supplies, proposing solutions as appropriate
You are:
Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e.
registered nurse) required.
Experience working with Global Teams
Advanced English Skills
Knowledge/experience on systems is relevant (VEEVA and others)
Budget Management knowledge is relevant
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.
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 functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements?
We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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