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June

Ctdm Specialist

Alcon - Macquarie Park, NSW

Health, Medical & Pharmaceutical
Source: uWorkin

JOB DESCRIPTION

  • Coordinate collection and processes essential trial documents between investigator sites and Alcon CDMA, including preparation and/or faciliating IRB/IEC submissions.
  • Ensure accuracy and quality of site documents included in the site initiation packets and throughout the duration of the study.
  • Enter and maintain site information and document tracking in current clinical trial management systems.
  • Ensure trial documentation is well organized, available, current, and archived in a timely manner in the sponsorTrial Master File.
  • Follow applicable work processes, SOPs, communication plans, etc.
  • Ensure timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budget and contracts, or other relevant documentation.
  • May interact with and advise other functions on CTDM responsibilities. Interactions include but are not limited to Global Clinical Side Development, Lead Clinical Site Managers, Clinical Site Managers, etc.
  • May assist with site budget negotiations and contract execution, processing of invoices and payments, and tracking of site study budgets.
  • May serve as a primary CTDM contact for small/low-complexity studies or for one or more specific document classes (i.e. budget/contracts).

Please refer to the Alcon U.S. Standard Minimum Requirements for the minimum education and experience requirements roles by GJFA band, job family and job subfamily. Our minimum education and experience standards are reviewed and updated periodically.


Preferred Qualifications:

Bachelor's degree in life sciences (Medical, pharmaceutical, biology, chemistry degree or RN)

2 years related experience (e.g., business administration)

1 years clinical trial experience

Proficient in Microsoft Office to include Word, Excel, PowerPoint

Excellent verbal and written communication skills

Excellent organization skills with exceptional attention to detail

History of working with multiple internal and external customers

Attched

Macquarie Park, NSW

Health, Medical & Pharmaceutical




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