Clinical Data Manager

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. The Clinical Data Manager is primarily responsible for processing and organizing patient data, ensuring accurate clinical data delivery, planning data validation, and supervising operational aspects. This role is on-site in our Fort Worth, Texas office and a typical day would include:

• Provides DM leadership across assigned trial(s) (4 or more). Acts as the Trial Data Manager where needed for 3-4 studies in parallel.
• Demonstrates a business understanding of the portfolio, products and indication to identify and assist in successful application of data management processes.
• Provides feedback to assure well-written protocols. Recognize and resolve protocol. issues that may impact database design, data validation, data integrity and/or analysis/reporting while making the best use of standards and best practices.
• Leads the team through database build requirements, timelines and complete startup activities for study including: building the eCRF, completion guidelines, standard and simple rules, data validation plan and user acceptance testing (UAT).
• Set up and manages external data in accordance with protocol requirements, process and validation requirements.
• Performs DM maintenance and validation activities during the study timely and with quality.
• Tracks and reports status and progress for assigned trials and projects. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks).
• Effectively communicates status updates and study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM).
• Responsible and accountable to ensure consistency of assigned trials with program level standards through technical implementation of Industry (CDISC and regulatory) Data Standards, providing support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy.
• Mentors and assists Junior team members.
• Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence.
• Ensures adherence to GCP, DM 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.

How You Can Thrive at Alcon:

• 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!
• Travel Requirements: Up to 10%

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, 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 alcon.recruitment@alcon.comand let us know the nature of your request and your contact information.