Alcon (501+ Employees, 13% 2 Yr Employee Growth Rate)
Summary of Position:
Alcon is looking to hire a Clinical Trial Lead to join our Clinical Research team Remotely. You will be accountable for all aspects of assigned clinical trials, leading the Clinical Trial Team, who is responsible for planning, conducting and reporting of clinical trials. You will author robust protocols with scientific rigor and quality. Trial conduct must be efficient, with seamless execution and timely reporting.
- Lead and matrix manage the global multidisciplinary Clinical Trial Team (CTT) who is responsible for planning, conducting and reporting on all clinical trials within CDMA. Each Clinical Trial Lead, leads 2 to 3 clinical trial teams for studies of low to medium complexity in support of one or more projects.
- Contribute feasibility input for the development of the protocol synopsis. Collaborate with the Medical Advisors to ensure country feedback is adequately integrated into the protocol.
- Independently ensure quality and timely execution of a clinical trial within timeline and budget
- Accountable for the development, management and tracking of trial budget.
- Accountable for accuracy of trial information in all trial databases and tracking systems
- Write scientifically rigorous protocols aligned with the approved protocol synopsis
- Lead CTT to select countries and sites
- Ensure investigational product supply
- Ensure Health Authority and IRB/IEC submission and approval
- Ensure all auxiliary documents, including manual of procedures, informed consent template, investigator brochure, statistical analysis plan, data validation plan, etc. are written in high quality and available.
- Define clinical outsourcing specifications and scope of work for clinical trial vendors. Oversee conduct of tasks.
- Ensure implementation of standard data collection modules, where possible or obtains approval for deviation.
- Resolve issues within the CTT or elevates issue to appropriate teams and governance committee.
- Ensure ongoing data quality review, data cleaning and database lock.
- Ensure reporting of results to Management, CTT and Core Team.
- Arrange and lead CTT Meetings and responsible for writing minutes
- Active participant of the Clinical Sub-Team
- Manage authoring, review and approval of the Clinical Study Report
- Assist with the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing packets, safety updates, regulatory submission documents, responses to Health Authorities questions.
- Responsible for implementation of best practices and standards for trial management, including sharing lessons learned
Key Requirements/Minimum Qualifications:
- Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
- The ability to fluently read, write, understand and communicate in English
- 7 Years of Relevant Experience
- Travel Requirements: Up to 20%
- Relocation assistance: No
- Sponsorship available: No
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.