Senior Study Manager (Drug Supply Management)
Location:
Fort Worth , Texas
Posted:
January 13, 2017
Reference:
200099BR
•Oversees all aspects of clinical supplies management ensuring there are sufficient supply
levels at sites and depots
•Represents clinical supplies function at clinical trial team meetings; communicates plan
and timelines to internal and external customers and partners
•Reviews clinical trial protocol and provides input to clinical supplies and IRT sections.
• Creates forecasts and packaging design based on study needs to ensure optimized supply
plan in terms of cost, feasibility and overage
• Proactively drives the labeling, packaging, release, distribution and return of clinical
supplies for assigned studies, ensuring the project timeline is met or exceeded.
• Participates in cross functional teams and provides guidance on best practices for clinical
supplies management
• Leads process improvement initiatives and training efforts as a clinical supplies SME
• Supports internal/external inspections and audits
• Maintains required documents in a manner consistent with cGMP, 21 CFR Part 11,
Annex 13 as well as internal QM, Corporate and Functional level SOPs Novartis is an Equal Opportunity Employer. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any 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. Minimum requirements •Bachelor's degree required; Master's degree is a plus
•Minimum 7-10 years of experience managing clinical supplies or relevant experience
•PMP certification is preferred
•Ophthalmology and/or Medical Device experience a plus
•Knowledge of cGMP, 21 CFR Part 11, and Annex 13 requirements
•English proficiency required
•Proficiency in the design and use of Interactive Response Technology
•Project management and process improvement experience
•Proven leadership behaviors and strong communication skills

A little about us:
As the global leader in eye care, Alcon develops and manufactures innovative medicines and devices to serve the full life cycle of eye care needs.

Know someone who would be interested in this job? Share it with your network.