Overview:
As a Business Analyst, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities:
Business Analyst is responsible for providing oversight to assigned aspects of TMF systems, processes and learning strategies. Supporting the TMF Process Owner and IT, the TMF Solutions Manager works with subject matter experts and leaders across all departments to ensure user needs are met and TMF strategies are consistent with the needs of the business, our clients and regulatory expectations. The TMF Solutions Manager is the liaison between operations and Corporate Services (e.g. IT, Process and Learning Management, etc.). Assignments may include new process initiatives, client requirements, system configuration and validation, vendor management, CAPA representation, as well as maintenance and ongoing oversight of existing practices.
Responsibilities:
* Services rendered will adhere to applicable Sponsor's SOPs, WIs, policies, local regulatory requirements, etc.
* Participate in analysis, development, testing and implementation of TMF and Document Management technology, including external systems and solutions.
* Develop, maintain and improve process and training courses/material for TMF strategies (e.g. SOPs, system manuals, client specific TMF Specifications, etc.).
* Lead assigned solutions for target
* Identify TMF solutions and standards for key
Might be asked to:
*
* Manage global projects and initiatives, including corporate strategies, CAPAs
* Identify TMF process and training gaps throughout the organization; strategize and lead implementation of solutions
* Collect, review, communicate and correct quality data through data analytics tools and processes Identify TMF solutions and standards for key clients
* Participate in analysis, development, testing and implementation of TMF and Document Management technology, including external systems and solutions
* Develop, maintain and improve training courses/material for TMF processes and systems (e.g. SOPs, system manuals, client specific TMF Specifications, etc.)
Qualifications:
* Bachelor or Master degree
* Min. 2-5 years in the industry working in a TMF department as TMF Specialist/ Lead
* Demonstrated application of processes, systems and maintenance of the paper and electronic Trial Master File.
* Proficient working within a Microsoft Office Environment Prior industry experience in a TMF-related
* Experience with problem solving/solution
* Prior experience in a leadership
* Prior experience leading TMF related functions or projects Experience with change management, training and process improvement techniques
* Knowledge of ICH/GCP, local regulatory authority and clinical development regulations
* Demonstrates excellent organizational and multi-tasking
* Demonstrates thorough follow-up and follow-thru to problem resolution, timelines
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
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Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. 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, 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 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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