Senior Clinical Project Lead (Lake Forest, CA Or Fort Worth, TX)

Novartis Pharmaceuticals Fort Worth , TX 76102

Posted 5 months ago

Job Description:

  • Lead the Clinical Sub Team (CST). Plan, conduct, and report all clinical trials of an Alcon Program or Project.

  • Contributes to the project development plan, including high-level clinical trial design.

  • Works with Therapeutic Unit Head (TUH) and Project Heads (PH), 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 studies aligned with the overall program and project plan.

  • Leads the Clinical Sub Team, in particular, take on responsibility for planning clinical trials, writing study protocols based on concept sheets, and writes study supporting documents.

  • Contributes to site selection and CRO selection process.

  • Conducts clinical studies, and along with CM (if assigned) 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.,

  • Briefing Books, NDAs, CE-Technical Files, and PMAs.

  • Serves as Core Project Team Member and is the primary contact for the Project Head (PH).

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 alcon.recruitment@alcon.com 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 alcon.er@alcon.com.

alrpo

Employment Type

Regular


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Senior Clinical Project Lead (Lake Forest, CA Or Fort Worth, TX)

Novartis Pharmaceuticals