Clinical Trial Document Management (Ctdm) Specialist

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a CTDM Specialist on Alcon's Clinical R&D team, you will be trusted to support clinical trial leads and trial sites to ensure timely and accurate completion of key clinical trial documentation and other requirements. In this role, you will:

• Ensure trial documentation is well organized, available, current, and archived in a timely manner in the sponsor Trial Master File and ensure audit readiness; provide support before and during audits, both internal and external when applicable.
• May provide assistance/support with training initiatives.
• Ensure accuracy and quality of site documents included in the site initiation packets and throughout the duration of the study.
• May serve as a primary CTDM contact for small/low-complexity studies or for one or more specific document classes (i.e., budget/contracts).
• Enter and maintain site information and document tracking in current clinical trial management systems.
• May interact with and advise other functions on CTDM responsibilities. Interactions include but are not limited to Global Clinical Site Development, Clinical Trial Lead, Clinical Site Managers, etc.
• Coordinate the collection and processing of essential trial documents between investigator sites and Alcon Clinical R&D (CRD), including preparation and/or facilitating Institutional Review Board (IRB)/Independent Ethics Committee (IEC) submissions.
• Ensure timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budget and contracts, or other relevant documentation.
• Follow applicable work processes, SOPs, communication plans, etc.
• May assist with site budget negotiations and contract execution, processing of invoices and payments, and tracking of site study budgets,if or when applicable

WHAT YOU'LL BRING TO ALCON:

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +8 yrs; Assoc.+4 yrs)
• The ability to fluently read, write, understand, and communicate in English.

Preferred Qualifications

• Degree in Life Sciences, Psychology, Public Health or related
• Strong collaborator; team-player
• Independent and proactive to ask questions or raise concerns without prompting
• Basic knowledge of clinical trial processes
• Ability to adapt and flex as the team evolves

HOW YOU CAN THRIVE AT ALCON:

• Alcon provides a robust benefits package including health, life, retirement, flexible time off, and much more!
• Benefit from working in a highly collaborative and diverse environment, as well as within a welcoming and empowered team.
• Join Alcon’s mission to provide top-tier, innovative products and solutions that enhance sight, enhance lives, & help others "See Brilliantly!"

Additional job details:

• Sponsorship available: no
• Relocation assistance: no
• Travel Requirements: minimal to no travel if located in Fort Worth; less than 10% if remote
• Work hours: Monday - Friday, 8 AM - 5 PM

Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. 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 send an email to [email protected] and let us know the nature of your request and your contact information.