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TMF Lead

  1. India
2024-111682
  1. Clinical Trial Support
  2. ICON Strategic Solutions
  3. Remote

About the role

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


What you will be doing:

 

The TMF Solutions Manager is responsible for providing oversight to assigned aspects of TMF systems, processes  and  learning  strategies.  Supporting the  TMF Process  Owner  and IT,  the  TMF Solutions Manager works with subject matter experts and leaders across all departments to ensure user needs are met and TMF strategies are consistent with the needs of the business, our clients and regulatory expectations. The TMF Solutions Manager is the liaison between operations and Corporate Services (e.g. IT, Process and Learning Management, etc.).  Assignments may include new process initiatives, client requirements, system configuration and validation, vendor management, CAPA representation, as well as maintenance and ongoing oversight of existing practices.

 

Deliverables:

  • Participate   in   analysis,   development,   testing   and   implementation   of   TMF   and   Document

Management technology, including external systems and solutions.

  • Develop, maintain and improve process and training courses/material for TMF strategies (e.g. SOPs, system manuals, client specific TMF Specifications, etc.).
  • Lead assigned solutions for target area.
  • Identify TMF solutions and standards for key clients.
  • Advanced:

o Manage global projects and initiatives, including corporate strategies, CAPAs, etc.

Identify TMF process and training gaps throughout the organization; strategize and lead implementation of solutions.

Collect, review, communicate and correct quality data through data analytics tools and processes Identify TMF solutions and standards for key clients.

o Participate in analysis, development, testing and implementation of TMF and Document

Management technology, including external systems and solutions.

o Develop, maintain and improve training courses/material for TMF processes and systems

(e.g. SOPs, system manuals, client specific TMF Specifications, etc.).

 

Metrics/KPIs:  Metrics/KPIs  governing  these  services  are  outlined  in  the  Quality  Oversight  Plan  (QOP)

document.

 

Interfaces –  Primary/Other:

  • Primary interfaces: Other TMF CoE team members, IT, functional area users, study teams (Cross- sector).
  • Other Interfaces: VEEVA.

You are:

 

Education and Experience Requirements:

  • 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.
  • Advanced:

o Knowledge of System Development Lifecycles.

o 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.


Why 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.

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.

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, 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.

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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