Icon Plc Chennai Hiring TMF Specialist
career opportunity as a TMF Specialist with Icon Plc in Chennai. This role is perfect for professionals with TMF experience and document management skills. Read on to learn more about the qualifications, responsibilities, and benefits of joining Icon Plc.
About Icon Plc: Icon Plc is a global leader in providing outsourced development services to the pharmaceutical, biotechnology, and medical device industries. With a focus on diversity and inclusivity, Icon Plc fosters a culture of innovation and collaboration.
TMF Specialist Role: As a TMF Specialist at Icon Plc, you will be responsible for completing Document Management activities in support of client services contracts and internal business needs. Key responsibilities include processing study documents, maintaining study files, participating in audits, and liaising with study teams and clients.
Job Responsibilities of TMF Specialist
- Maintain effective communication with clinical trial teams and CRO staff throughout trial start-up, maintenance, close-out, and archive
- eTMF Health: Manage open Quality Issue (QI) lists for assigned trials to ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated.
- Closes and reassigns QIs as necessary.
- eTMF Health: Manage Expected Document Lists (EDL) and counts for the life of assigned trials partnering with the Clinical Trial Team (CTT) and CRO team.
- Escalate non-compliance with EDL business process to the eTMF Manager as needed.
- eTMF Health: Provide scheduled and ad-hoc analysis and metrics on TMF Health for eTMF Managers and CTT/CRO teams on assigned trials.
- Be responsible for TMF activities for assigned trials including:
- Supporting TMF document filing into Moderna eTMF system.
- Maintaining the naming and filing guide specific to TMF documents.
- Conducting ad-hoc quality checks and review of document content uploaded into the eTMF.
- Responding to inquiries regarding TMF management and contents.
- Supporting inspection/audit preparation and remediation activities.
- Attend departmental and trial-specific meetings and discussions, as required.
- Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements.
- Performs general administrative tasks related to their assigned trials.
- Completes other TMF document-related tasks as required by the eTMF Manager or department head.
Qualifications and Experience:
Benefits of Joining: Joining Icon Plc offers ongoing career development opportunities, a competitive salary, health coverage, paid time off, income protection insurance programs, and staff recognition schemes. Grow your career and enhance your skills in a dynamic and supportive work environment.
How to apply for Icon TMF Specialist role
If you have experience and relevant skills, Apply Here
To apply for this job please visit careers.iconplc.com.
