TMF Lead

Overview

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

Responsibilities

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.

Qualifications

You are:

• Undergraduate degree (or its international equivalent from an accredited institution). 2-5 years in the industry working in a TMF related area in replacement of education.

• Demonstrated application of processes, systems and maintenance of the paper and electronic Trial Master File.

• Read, write and speak English, fluent in host country language.

• Proficient working within a Microsoft Office Environment Prior industry experience in a TMF-related field.

• Experience with problem solving/solution implementations.

• Prior experience in a leadership role.

• Prior experience leading TMF related functions or projects Experience with change management, training and process improvement techniques.

• Knowledge of ICH/GCP, local regulatory authority and clinical development regulations

• Demonstrates excellent organizational and multi-tasking skills.

• Demonstrates thorough follow-up and follow-thru to problem resolution, timelines and deliverables.

• Demonstrates leadership and delegates appropriately.

• Advanced understanding of processes, systems and maintenance of the paper and electronic Trial Master File.

• Knowledge of change management, training and process improvement methodologies.

• Knowledge of System Development Lifecycles.

• Certification in Project Management, Six Sigma or LEAN.

• Coursework in business issues and management (e.g. operational analysis, organization behavior, budgets, etc.), required for experienced candidates.

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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.