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Clinical Project Lead

Company: Alcon Pharma
Location: Lake Forest
Posted on: November 21, 2022

Job Description:

Summary of Position:Alcon is looking to hire a Clinical Project Lead to join our Clinical Development team in Fort Worth, TX or Lake Forest, CA location. You will be responsible for overseeing, designing, planning and developing clinical evaluation research studies.Key Responsibilities: Represents the Clinical R&D function at the Project core team and acts as the single point of contact for the Project Head on all clinical activities/functionsOversees all aspects of Clinical R&D related to the project's stage in the R&D portfolioLeads clinical sub-teams on clinical strategy, designs, executes and participates in clinical trial teams to oversee conduct and reportingDesigns and provides oversight of clinical research programs in the assigned therapeutic area(s) Builds relationships with key opinion leaders and applies their input to enhance study design and protocols Confirms that clinical research program design meets scientific objectives and is aligned with commercial needs Serves as a medical/scientific consultant to marketing or research project teams and government regulatory agencies Establishes the criterion essential for determining the safety, efficacy, and value of products in the surgical franchise Prepares and authors protocols with the trial management team and patient record forms Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application Collaborates and serves as the key clinical partner with regulatory team on PMA submissions, Q-Sub meetings for the projectOversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets May be responsible for clinical supply operations, site and vendor selection Conducts post marketing studies, life cycle management and training of customer facing medical affairs associates worldwideKey Requirements/Minimum Requirements Bachelor's Degree or Equivalent years of directly related experience(or high school +13 yrs; Assoc.+9yrs; M.S.+2yrs; PhD+0 yrs)The ability to fluently read, write, understand and communicate in English5 Years of Relevant ExperienceWork hours: 40 hoursTravel Requirements: 20% DomesticRelocation available: YesSponsorship available: YesPreferred Qualifications/skills Experience:Degree in Optometry/Ophthalmology/Vision ScienceExperience in writing clinical study protocolsExperience in planning, conducting, and reporting clinical research in vision scienceExperience in clinical trials regulations example, GCP, ISO standards.Experience in the field of Diagnostics, real world evidence, cataract surgery planning/refractive outcomes assessment is preferredAlcon 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 and let us know the nature of your request and your contact information.SummaryLocation: Fort Worth, Texas; Lake Forest, CaliforniaType: Full time

Keywords: Alcon Pharma, Lake Forest , Clinical Project Lead, Other , Lake Forest, California

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