Manager I, Clinical Research

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This role is part of Alcon's Research & Development function, Conduct routine and on-demand literature search activities for the Alcon Knowledge Center, supporting internal stakeholders by refining search strategies to enhance the relevance and quality of retrieved publications. Provided concise summaries of reported adverse events and complaint records to aid in regulatory and clinical decision-making.  While also including leadership of direct reports, ensuring quality/efficient stakeholder management and ensuring compliance with policies and procedures.

This is same purpose as Associate level. I would think this Job Purpose would include some aspect of people leadership, ensuring quality/efficient stakeholder management, and ensuring compliance to policies and procedures.

Specifics Include:

•

• Liaise with vendors and publishers to resolve technical issues and communicate service-impacting changes across the organization.
• Manage acquisition and analysis of usage data to inform journal selection and subscription decisions.
• Retrieve full-text articles for Reprints Desk bounce backs to ensure uninterrupted access to requested literature.
• Develop and deliver training tutorials and sessions to support end-user proficiency with knowledge center tools and resources.
• Provide required usage reporting to the Copyright Clearance Center to ensure compliance with licensing agreements.
• Respond to inquiries received through the Ask AKC mailbox, offering timely and accurate support to internal stakeholders.
• Provide leadership, direction, and prioritization for the Medical Literature Analyst team, ensuring alignment with organizational goals and efficient execution of literature search and summarization activities. Oversee daily operations, support professional development, and foster a collaborative, high-performance work environment.
• Develop and execute targeted literature search strategies based on clinical protocols, product names, and other relevant criteria to support a range of functions, including
  • Clinical Evaluation Reports (CERs), State of the Art (SotA) reviews, and Safety and Performance assessments.
  • Conduct annual queries for both clinical and nonclinical reports in collaboration with Regulatory Affairs.
  • Provide literature support for Medical Safety and Complaint Intake, as well as ad-hoc search requests from departments such as Medical Information and Health Economics and Outcomes Research (HEOR).
• Perform summarization analysis to identify any new complaints / risks identified in publications and add to appropriate system(s)
• Execute process activities in accordance with established Standard Operating Procedures (SOPs).
• Maintain a strong understanding of data requirements for technical and adverse event (AE) complaints to ensure compliance.
• Collaborate effectively across global time zones to support international operations.
• Review data entry and follow-up documentation for accuracy, completeness, and timeliness.
• Stay current with company policies, departmental procedures, and relevant work instruction and ensure adherence to all corporate compliance guidelines and programs.
• Demonstrate working knowledge of ophthalmic terminology, including eye anatomy, common diseases, and procedures.
• Proactively identify and escalate potential safety issues, emerging trends, or areas of concern to management.
• Provide support for reconciliation activities and audits as needed.
  
  Minimum Qualification:
• Bachelor's degree in science or healthcare field
  3-5 years relevant work experience [i.e. device / drug safety, compliance, quality assurance, or data analytics] including managing direct reports 3-5 years relevant work experience [i.e. device / drug safety, compliance, quality assurance, or data analytics] including managing direct reports
• Experience communicating with US-based customers
• Experience in Medical Device / Pharma Complaint Handling / Device Vigilance / Pharmacovigilance

• Proven strong leadership skills and ability to interact with and influence senior leadership

  Excellent listening ability and communication skills

  Excellent decision making, troubleshooting and negotiation skills Ability to manage multiple tasks, attention to detail, prioritize work and manage time well

  Knowledge and understanding of national and international medical device regulations and regulatory guidelines

  Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practice

  Basic knowledge of MS Office

  Excellent written and verbal communication skills

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