A typical day will include :
- Ensuring the 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.
- Acting as the Trial Data Manager where needed for three to four studies in parallel. Providing DM leadership across assigned trial(s) (4 or more).
- Providing feedback to assure well-written protocols. Recognizing and resolving 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.
- Tracking and reporting status and progress for assigned trials and projects. Being proactive to ensure milestones are met with quality (incl.
Snapshots and interim / final locks).
- Processing, reviewing, and receiving patient data and records and organizing clinical data forms from particular therapeutic groups and outside investigators.
- Maintaining up-to-date, knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.
g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
- Providing accurate, timely, and consistent clinical data to the medical department and other groups
- Following Good Clinical Practices (GCP) data-handling procedures and 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; PhD+0 yrs)
- The ability to fluently read, write, understand, and communicate in English.
- 2 years of relevant experience
- Travel Requirements : No
- Relocation assistance : No
- Sponsorship available : No
HOW YOU CAN THRIVE AT ALCON :
- 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!
PREFERRED QUALIFICATIONS :
- Bachelor’s degree in Life Science, Computer Science, Pharmacy, Nursing, Computer Programming or equivalent relevant degree.
- Master’s Degree
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