Sr. Associate I, Clinical Research
4 days ago
At Alcon we re passionate about enhancing sight and helping people see brilliantly With more than 25 000 associates we innovate fearlessly champion progress and act swiftly to impact global eye health We foster an inclusive culture recognizing your contributions and offering opportunities to grow your career like never before Together we make a difference in the lives of our patients and customers Are you ready to join us This role is part of Alcon s Research Development function a team that innovates boldly and delivers new products and services to help revolutionize the eye care industry advance optimal patient outcomes and help people see brilliantly The Sr Associate I Clinical Research Non-MD Science Tech Engineering Path is primarily responsible for conducting studies to test drug efficacy and safety designing clinical protocols and collaborating with investigators and the Clinical Research Operations team You will contribute to data analysis and interpretation using scientific principles to solve problems and innovate Conducted 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 Major Accountabilities 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 of 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 instructions 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 Ensure adherence to all corporate compliance guidelines and programs Provide support for reconciliation activities and audits as needed Minimum Requirement Bachelor s degree in science or healthcare field Experience in Medical Device Pharma Complaint Handling Device Vigilance Pharmacovigilance Experience communicating with US-based customers 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 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 Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment We do not 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 status disability or any other reason
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