New

Clinical Operations Lead

Alcon
flex time, relocation assistance
United States, Texas, Fort Worth
Jan 22, 2025
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon and we are looking to hire a Clinical Operations Lead to work remotely who will be responsible for performing project management tasks at country, regional and site level in support of planning, conduct and reporting of clinical trials. Trial conduct must be efficient, with seamless execution, achievement of timelines and study deliverables with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures. Experience in ophthalmology clinical trials would be strongly preferred. In this role, a typical day will include: 1. Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of clinical trials within CRD. Each COL will be assigned 2-3 clinical trials of low to medium complexity in support of one or more projects. 2. Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures. 3. Ensure consistency of Alcon's processes and procedures across sites and studies. 4. Contribute operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, etc. 5. Develop Protocol Monitoring Plan (PMP). 6. Follow study metrics using all available tools, systems and information (e.g., CTMS, EDC, CDM reports) to ensure achievement of target study milestones and deliverables. 7. Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, milestones, and status of CSM activities. 8. Coordinate study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulations. 9. Coordinate, prepare, deliver, and track protocol specific training for site personnel and assigned CSMs. 10. Initiate Investigational Product shipment requests, resupply and coordinate reclamation of supplies for sites on assigned trial(s). 11. Create and maintain user account worksheets for provisioning all site personnel and Clinical Trial Team (CTT) members for assigned trials into required systems (e.g. EDC, IRT, training portals). 12. Actively participate on the CTT, building relationships and serving as liaison among trial team personnel as appropriate. 13. Facilitate communication between CTT and sites. 14. Provide progress reports to CTT and upper management routinely. 15. Proactively identify potential/actual issues and risks, escalate to CTT and management as appropriate, and contribute to mitigation. 16. Participates in department and cross-functional process improvement initiatives to improve operational efficiencies. Experience: * 5 years of field clinical monitoring, site management (e.g., study coordinator), or clinical research experience * Project Management experience preferred * Excellent verbal and written communication, problem solving skills and team leadership * Achievement of project specific milestones for assigned trials as defined in overall CRD objectives: First Patient First Visit (FPFV), Last Patient First Visit (LPFV), Last Patient Last Visit (LPLV), and Database Lock (DBL) * High quality/compliance in assigned trials as defined in overall CRD objectives * Adherence to processes and procedures * Proactive identification and mitigation of issues/risks * Customer Focus * Action Oriented * Collaborates * Communicates Effectively * Plans & Aligns What You'll Bring to Alcon: Bachelor's Degree or Equivalent years of directly related experience (or high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs) The ability to fluently read, write, understand, and communicate in English 5 Years of Relevant Experience How You Can Thrive at Alcon: Join Alcon's mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more! Travel Requirements: 0-5% Relocation assistance: Yes Sponsorship available: Yes Alcon Careers See your impact at alcon.com/careers #LI-DNI ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker 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.