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Lead Clinical Data Manager - Ethicon, Inc.

Company: Disability Solutions
Location: Raritan
Posted on: May 11, 2024

Job Description:

Ethicon, Inc, part of the Johnson & Johnson family of Medical Device companies, is current recruiting for a Lead Clinical Data Manager . This role will work a Flex/Hybrid schedule with 3 days per week in office and must reside within a commutable distance of Raritan, NJ . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at 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. Primary Responsibilities: --- 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 $150,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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.

Keywords: Disability Solutions, New Brunswick , Lead Clinical Data Manager - Ethicon, Inc., Executive , Raritan, New Jersey

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