Join to apply for the Business Analyst I role at ICON Strategic Solutions.
As a Business Analyst, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The 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 aligned with business, client, and regulatory requirements. The TMF Solutions Manager acts as a liaison between operations and Corporate Services (e.g., IT, Process and Learning Management). Assignments may include process initiatives, client requirements, system configuration, validation, vendor management, CAPA, and maintenance of existing practices.
Responsibilities
* Ensure services adhere to Sponsor's SOPs, WIs, policies, and regulatory requirements.
* Participate in analysis, development, testing, and implementation of TMF and Document Management technology, including external systems.
* Develop, maintain, and improve process and training materials for TMF strategies (e.g., SOPs, manuals, specifications).
* Lead assigned solutions for targeted initiatives.
* Identify TMF solutions and standards for key processes.
Might Be Asked To
* Manage global projects and initiatives, including strategies and CAPAs.
* Identify gaps in TMF processes and training, and lead implementation of solutions.
* Analyze quality data and communicate findings.
* Develop and improve training courses/materials for TMF processes and systems.
Minimum Qualifications
* Bachelor's or Master's degree.
* 2-5 years of experience in a TMF department as a TMF Specialist/Lead.
* Experience with paper and electronic Trial Master Files.
* Proficiency in Microsoft Office.
* Knowledge of ICH/GCP and regulatory requirements.
* Strong organizational and multi-tasking skills.
What ICON Can Offer You
Our success depends on our people. We are committed to diversity, high performance, and talent development. Benefits include competitive salary, health insurance, retirement plans, employee assistance programs, and flexible benefits tailored to each country.
Visit our careers website for more: https://careers.iconplc.com/benefits.
ICON values inclusion and accessibility. We are dedicated to providing a workplace free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, religion, gender, or disability. For accommodations, contact us via this form.
Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for.
Additional Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research, Analyst, IT
* Industry: Pharmaceutical Manufacturing
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