Tmf Specialist Iii

As a TMF III you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

**What you will be doing**:

- Performs Quality Check and indexing of TMF documents for in-house studies.
- Supports compilation of the TMF Management Plan and TMF Index in association with the TMF Owner and CROs.
- Ensures that documentation flow for Trial Master File documents meets the required timelines and intervenes with action plans and follow up as appropriate.
- Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF; assists with responses about documentation management activities for audits, questions, and issues.
- Attends internal project team and sponsor teleconferences.
- Coordinates TMF milestones in collaboration with the study team, according to the established timelines and quality criteria.
- Provides regular feedback to the Project Team on TMF status, including actionable metrics. Whenever necessary, provides re-training to the Project Team.
- Manages study setup in the eTMF System on a timely basis for studies assigned and communicate same to end users.
- Performs CRO TMF completeness review for metadata checks and targeted missing items according to each CRO’s TMF Plan and TMF Index.
- Manage and Prioritize the Completeness Review Listing for all In-House and CRO studies according to the established milestones; send and follow-up with the Study Team.
- Experience with the DIA Reference Model.

**You are**:

- Proficient in TMF management
- Experience with Veeva Vault TMF
- Attention to detail
- Organized, adaptable, strong communication skills, capable of high volume of requests, problem solving skills
- High English level

**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