Location
Home office | Brazil
Job description
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
As TMF Lead you will:
- Own the TMF deliverable
- Engage and lead cross-functional teams to achieve Inspection Ready eTMFs at all times
- Deliver best-in-class customer support for our Sponsors/Clients whether using our ICON eTMF or an external eTMF.
- Actively listen to and deliver insightful solutions for challenges
- Identify opportunities to create efficiencies and participate in automations & integrations
- Lead the setup of the TMF
- Monitor and drive completeness and quality of TMF content for all assigned clinical trials until study close out.
- Oversee documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors.
- Ensure consistent use of standardized processes and systems across assigned clinical trials and programs
- Assist with the development and implementation of the TMF specifications, such as process and system changes.
- Serve as primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.
- Facilitate communication and interaction among study team members from the set up until the closing of the TMF for a clinical trial.
- Provide education, feedback and support to Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
- Determine and review study specific TMF specifications to ensure quality and standardization is established per program and kept up to date as program/protocols progress.
- Maintain Study Specific Document Lists (SSDLs) at the study, country and site levels by collaborating with all relevant Functional Lines (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
- Conduct periodic quality review of Study Specific Document Lists (SSDLs) at all levels and liaise with the Functional Line Document Owners to ensure that all findings are addressed and remediated in a timely manner.
- Support Study Team in the effective management of TMF when working external vendors.
- Support Study Team to ensure document quality requirements are agreed to and met, according to Completeness, Timeliness and Quality metrics, and enforce ownership and accountability across study teams.
- Ensure complete TMF is in place at time of study close/submission.
What you need?
- Must have more than 3 years of TMF (Trial Master File) experience and strong knowledge of Clinical Studies documents. Ability to successfully liaise with study project teams, staff, clients and management, as necessary.
- Excellent oral and written communication skills and interpersonal skills.
- Bachelor’s Degree in Life Science preferred
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Benefits of Working in ICON:
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.
At ICON, 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.
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, color, 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.
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