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TMF Lead

  1. Warsaw
JR118509
  1. ICON Full Service & Corporate Support
  2. Regulatory Document Management
  3. Hybrid: Office/Remote

About the role

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At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
 

TMF Lead

Role summary:

As a TMF Lead you will be responsible for the complete and accurate Trial Master Files through documentation of quality, consistency, and timely filing across all assigned clinical trials.

Responsibilities:

• Recognize, exemplify and adhere to ICON's values, which center on our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Lead the setup of the TMF Study Specific Document List (SSDL)
• Monitor completeness and quality of TMF content for all assigned clinical trials until study close out.
• Support 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 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.
• Apply lessons learned to continuous improvement of documentation management practices across study teams.
• 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.
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with PM or equivalent if modifications are necessary.
• 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.
• Support study Team in addressing/reporting regulatory queries pertaining to document management.
• Ensure complete TMF is in place at time of study close/submission.
• Mentor new employees in specified TMF Owner tasks and duties, if required

Qualifications:

• Bachelor’s Degree in Life Science preferred.

• At least 1 year of TMF or relevant experience in a CRO. Ability to successfully liaise with study project teams, staff, clients and management, as necessary.

Excellent oral and written communication skills and interpersonal skills. 
Ability to manage multiple priorities in a fast-paced environment.
Knowledge of clinical trial processes and regulations.

• Willingness to Travel (approximately 5%) on domestic and/or international travel.

#LI-SK1

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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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