Ethicon , part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world’s most pressing health care issues and improve and save more lives. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .
The Lead Clinical Data Manager (LDM) is responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned trials with minimal supervision. The LDM ensures clinical trial data collected meet the highest standards of data integrity while meeting timelines. This role will work a Hybrid schedule and must be based within a commutable distance of Raritan, NJ.
Position Duties & Responsibilities:
Reporting to the Manager, Data Management this individual will:
• Mentor and train junior associates as needed in clinical data management processes and procedures.
• Coordinate and lead the clinical database build activities, including creation of data management documentation such as the Case Report Form, Data Management Plan, database specification documents, Data Transfer Agreement, etc.
• Independently lead multiple complex trials, including the oversight of CRO activities, when applicable. Monitor progress of assigned studies to ensure that data management related contributions remain on target per the project timelines.
• Ensure data quality through proactive independent data review, discrepancy management and coordination of data review by key study partners (Clinical Operations, Clinical Franchise, Safety, Biostatistics and Statistical Programming).
• Handle and process non-CRF data, including lab data and image handling.
• Coordinate with the study medical and safety leads to facilitate medical term coding and safety reviews. Use knowledge of medical coding (MedDRA, WHODrug) to proactively identify potential data issues.
• Use technical skills to program and schedule reports using tools/languages such as Business Objects, R, Python, and/or SAS to review the clinical data by the clinical team.
• Contribute towards process improvement, data standards and initiatives to improve efficiency within the Biometrics team and Clinical Development department, working with leadership as needed.
• Perform other related duties as required.
The base pay range for this position is $105,000 to $155,000 based on experience .
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.