Overview:
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Job Title: TMF Specialist II/III
Location : Bangalore
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.
* 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.
Qualifications:
You are:
* Bachelor's degree in life sciences, clinical research, or a related field.
* Extensive experience in TMF management or clinical operations within the pharmaceutical or clinical research industry.
* Strong understanding of GCP, ICH guidelines, and global regulatory requirements related to TMF management and clinical trial documentation.
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/benefits
At 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
https://careers.iconplc.com/reasonable-accommodations
Interested 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.
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