Standards and Systems Lead

Posted 8 Hours Ago
Be an Early Applicant
Fort Worth, TX
Junior
Healthtech • Biotech • Pharmaceutical
The Role
As a Standards and Systems Lead, you will oversee database development activities, ensure adherence to industry data standards, and provide technical consultation for various data management projects. Your role involves user acceptance testing, collaborating with teams, and ensuring compliance with regulatory guidelines.
Summary Generated by Built In

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 Standard and Systems Lead supporting the U.S. Data Management team, a typical day will include:

  • Responsible for database development activities, including form design, layout and moderate to advanced rule building.  Responsible for 2-3 studies in parallel, including user acceptance testing

  • Uses database programming techniques to solve specific validation and custom development needs

  • Responsible and accountable to ensure consistency of standards through technical development, implementation of Industry (CDISC and regulatory) Data Standards and acts as a technical consultant providing standards input to all relevant area data management and reporting areas.

  • Understands and manages metadata to compliment data provisioning in compliance with global standards.

  • Establishes and maintains strong working relationships within Data Management and collaborates with TDM for database related needs.

  • Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, electronic data load, interactive response technology, electronic patient reported outcomes, clinical trial management systems, metadata management and other clinical database development activities.

  • Communicate and ensure that project objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.

  • Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence.

  • Understands Health Authority requirements and ensures adherence to GCP, standards, SOPs/procedures, job aids and guidelines.

  • Maintain up-to-date, knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.

WHAT YOU’LL BRING TO ALCON:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)

  • The ability to fluently read, write, understand and communicate in English

  • 2 Years of Relevant Experience

  • Work hours:40 hours

  • Relocation: No

  • Sponsorship Assistance: No

HOW YOU CAN THRIVE:

  • Collaborate with teammates to share standard processes and findings as work evolves

  • See your career like never before with focused growth and development opportunities

  • Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career!

  • Alcon provides robust benefits package including health, life, retirement, flexible time off and much more.

Alcon Careers

See your impact at alcon.com/careers

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

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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.

The Company
HQ: Geneva
20,962 Employees
On-site Workplace
Year Founded: 1945

What We Do

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning more than seven decades, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 20,000 associates are enhancing the quality of life through innovative products, partnerships with eye care professionals and programs that advance access to quality eye care.

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