Site Management Associate I - Medical Affairs
- Brazil
- Clinical Trial Support
- ICON Strategic Solutions
- Office Based
TA Business Partner
- Icon Strategic Solutions
About the role
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
- Experience including document up-load, report extraction to supporting ensure that study are inspection readiness state by taking an oversight over study eTMF completeness.
- Advanced English is necessary.
- Office based
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
Teaser label
Inside ICONContent type
BlogsPublish date
10/03/2022
Summary
In traditional clinical trials, patients must attend regular check-ins at hospitals or clinics but fully remote decentralised clinical trials (DCTs) and hybrid trials limit this by replacing the in-pe
Teaser label
Inside ICONContent type
BlogsPublish date
05/22/2022
Summary
Having enjoyed steady growth over the last several years, it’s predicted that the global clinical trials market will hit a value of $65.2 billion by 2025, and around 58% of this can be attributed to r
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