As a (TMF Specialist II) you will be joining the world’s largest most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities:

• 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.

• Minimum B.A./B.S. degree preferably in science or healthcare.

• 2+ years work experience, preferably in a relevant clinical research setting.

• 1+ years experience in eTMF document management (in a specialized team or as a member of a clinical trial team) is an advantage.

• Strong organizational/prioritization skills for the management of workload and attention to detail.

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.