Tmf Specialist Iii

Detalles de la oferta

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 withthe 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


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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