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TMF Specialist I or Clinical Project Associate

  1. Warsaw
JR112245
  1. ICON Full Service & Corporate Support
  2. Regulatory Document Management
  3. Office Based

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.

Role Overview:


To become familiar with Trial Master file documentation and TMF Operations activities in support of client services contracts and internal ICON business needs in accordance with client requirements and ICON procedures, as applicable

Responsibilities:

*To acquire knowledge and skills to process study documents in accordance with client and study requirements as per study-specific processes, ICON SOPs/WPs and regulations, where applicable.
• *To acquire knowledge and skills to complete activities related to document receipt and processing which may include but is not limited to: document receipt and review, scanning and indexing, quality control, copying, filing, forwarding or return to client/study teams and archiving.
• *To liaise with global study teams and other TMF Operations staff in order to fulfil job responsibilities and activities with supervision.
• *To complete departmental projects as assigned in accordance with specified timelines, ICON SOPs/WPs and regulations.
• *To maintain study files as per study and/or client requirements or in accordance with ICON SOPs/WPs and applicable regulations.
• *To provide information necessary to complete client and/or departmental status reports as requested by the management of the TMF Operations department.
• *To inform the Manager of training issues, project activities, quality issues and timelines as directed.
• *To provide copies of study documents to ICON or client personnel as requested.
• To participate in client and/or ICON audits as necessary.
• *To participate in document archiving activities as necessary.
• *To participate in training related to fulfilment of responsibilities as required by ICON and/or the client.
• To liaise with clients, as appropriate, on project issues when directed by the Manager.
• To handle special projects or duties as requested by the Manager.
• To be familiar with Indexing of documents with correct attributes and Performing technical QC (wherever required)
• To be familiar with applicable TMF Master Lists and any project specific requirements.
• Travel (approximately 5%) domestic and/or international



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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Similar jobs at ICON

TMF Specialist (All Levels)

Salary

Location

India, Chennai

Department

Clinical Trial Management

Location

Bangalore

Chennai

Bengaluru

Remote Working

Office Based

Business Area

ICON Full Service & Corporate Support

Job Categories

Regulatory Document Management

Job Type

Permanent

Description

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 I

Reference

JR126981

Expiry date

01/01/0001

Amrutha Saidala Read more Shortlist Save this role
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