Sr. CDMA Project Lead - Phacoemulsification Equipment
Lead the Clinical Sub Team (CST). Key person responsible for the global clinical trial strategy for the products/brand.
• Plan, conduct, and report all clinical trials of an Alcon Project.
• Contributes to the project development plan, including high-level clinical trial design.
• Works with Project Heads (PH) and project core team to create and understand the clinical aspects of the development plan and clinical trial requirements.
• Provides input to the development plan and study concept sheets.
• Designs clinical studies (exploratory, feasibility and confirmatory trials) aligned with the overall project plan.
• Accountable for ensuring high quality, scientifically sound clinical protocols and related documents that produce clear, decisive results.
• Leads the Clinical Sub Team, in particular, take on responsibility for planning clinical trials, writing study protocols based on concept sheets, investigator brochures and writes study supporting documents.
• Contributes to site selection and CRO selection process.
• Conducts clinical studies, and along with Clinical Manager & ensures study conduct is within timelines and budget.
• Ensures the accuracy of trial information in Clinical Trial Management System (CTMS).
• Contributes to ongoing scientific review of data (data cleaning, safety reporting and related activities.
• Ensures accuracy and timely completion of clinical study reports. Writes clinical content of submission dossiers to regulatory authorities, including, e.g., Q-sub, IDE, CE-Technical Files, and PMAs.
• Serves as Core Project Team Member and is the primary contact for the Project Head (PH).
• Accountable for medical/scientific review of clinical trial data, final analysis and interpretation within clinical trial reports, publications and internal/external oral and written presentations.
• Stay abreast of relevant literature and clinical practice norms for the project/program area(s).
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. Equal Employment Opportunity Posters: If you'd like to view a copy of the Alcon's affirmative action plan or policy statement, please email [email protected]
EEO Statement Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not 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.
Minimum requirements • Bachelor's Degree or Equivalent years of directly related experience (or high school +15yrs; Assoc.+11yrs; M.S.+4yrs; PhD+3yrs)
• The ability to fluently read, write, understand and communicate in English
• 7 Years of Relevant Experience
• 5 Years of Demonstrated Leadership
• Minimum 7 years technical and operational experience in planning, executing, reporting and publishing clinical studies.
• Experience in managing global multi-center clinical trials across multiple geographic regions
• Demonstrated ability to establish strong scientific partnership with key external collaborators.
• Proficient in MS Word, Excel, and PowerPoint
• Thorough knowledge of Good Clinical Practice, clinical trial design and clinical ophthalmic endpoints/assessments
• Good understanding of statistics, regulatory processes, and global clinical development process.
• Excellent written and verbal communication skills with successful presentation capabilities.
• Result oriented; quality work provided even when operating under tight timelines.
• Strong track record for being a team player and open for innovation.
• Previous experience in interactions with Health Authorities is preferable.
• Ability to manage multiple projects simultaneously
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