ICON Life Sciences BSc Jobs – TMF Specialist Role
ICON Life Sciences BSc Jobs – TMF Specialist Role. BSc Life Science job at ICON. ICON Careers. Interested and eligible applicants can check out all of the details on the same below.
Possible Interview questions are posted below
About the role
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
As a TMF Specialist I/II you will complete Document Management activities in support of client services contracts and internal ICON business needs.
Position: TMF Specialist (All Levels)
Job ID: JR100273
Location: BANGALORE, CHENNAI
Work Type: OFFICE BASED
About the role
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.
As a TMF Specialist I/II you will complete Document Management activities in support of client services contracts and internal ICON business needs.
Responsibilities:
- Process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.
- Liaise with study teams and other TMF staff in order to fulfill job responsibilities and activities.
- Complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.
- Maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.
- Complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
- Provide information necessary to complete client and/or departmental status reports as requested by the management of TMF department.
- Inform the Manager of training issues, project activities, quality issues and timelines as directed.
- Provide copies of study documents to ICON or client personnel as requested.
- Participate in client and/or ICON audits and document archiving activities as necessary.
- Participate in training related to fulfillment of responsibilities as required by ICON and/or the client.
- Liaise with Clients, as appropriate, on project issues when directed by the Manager.
- Handle special projects or duties as requested by the Manager.
What you need?
Experience: Must have 1-12 years of TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
Skills required: Good oral and written communication skills and interpersonal skills.
Preferred Qualification: Bachelor’s Degree in Life Science preferred
Why join us
Ongoing development is vital to us, and as a member of our team you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. We offer a very competitive salary and benefits package that includes an excellent recruitment plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.
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Here are a few interview questions with answers for the role of TMF Specialist (All Levels) at ICON:
1. Can you explain your experience with Trial Master File (TMF) management and your understanding of its importance in clinical studies? Answer: During my [X] years of TMF experience, I have been responsible for ensuring the completeness, accuracy, and timeliness of study documents within the TMF. I understand that the TMF serves as a critical repository for essential trial documentation, including regulatory and ethical approvals, investigator records, and study-related communications. Maintaining a well-organized and inspection-ready TMF is vital for ensuring compliance with regulations and facilitating efficient study conduct.
2. How do you ensure adherence to study-specific processes and applicable regulations while managing TMF documents? Answer: To ensure compliance, I carefully review study requirements, ICON SOPs/WPs, and applicable regulations to understand the specific document management processes. I maintain clear communication with study teams and other TMF staff, seeking clarification when needed. By following documented procedures, conducting quality control checks, and staying updated on regulatory guidelines, I ensure that TMF documents are processed and maintained accurately and in accordance with requirements.
3. Can you provide an example of a challenging TMF-related project you have completed? How did you handle it? Answer: In a previous project, we had a tight deadline to reconcile and organize a large volume of study documents for inspection readiness. To tackle this challenge, I developed a detailed project plan, prioritized tasks, and effectively collaborated with the study team and TMF staff. I allocated resources efficiently, implemented streamlined document review processes, and utilized technology to enhance productivity. By maintaining open communication and actively managing the project, we successfully met the deadline while ensuring document accuracy and completeness.
4. How do you handle situations where there are conflicting priorities and deadlines for TMF-related tasks? Answer: In such situations, I first assess the urgency and impact of each task. I communicate with relevant stakeholders, including study teams and management, to gain clarity on priorities. If necessary, I negotiate timelines and propose alternative solutions to ensure critical tasks are completed on time without compromising quality. By effectively managing expectations and maintaining open lines of communication, I strive to find a balance and meet the demands of multiple tasks effectively.
5. How do you stay updated with evolving regulations and best practices related to TMF management? Answer: I recognize the importance of staying current with industry trends and regulatory changes. I actively participate in training programs, attend webinars, and engage with professional networks to enhance my knowledge. I also regularly review regulatory guidelines and publications from reputable sources. By continuously seeking opportunities to learn and adapt, I ensure that my TMF practices align with the latest standards, enabling efficient and compliant document management.
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