MANAGER CLINICAL DATA MANAGEMENT

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 https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Somerville, New Jersey, United States of America

Job Description:

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 https://www.jnj.com/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

OVERALL RESPONSIBILITIES:

The Manager, Data management, will  be responsible for oversight and management of all aspects of clinical data management associated with entry, cleaning and quality review process across the Medical Devices Sector. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.

POSITION DUTIES & RESPONSIBILITIES:

 Reporting to the Director, Data Management and Clinical Systems, this individual will;

• Ensure efficient use of resources across the franchise to provide high quality clinical data, on time, within budget by monitoring progress and conduct of their teams respective projects. This includes all data cleaning and QC activities and partnering as appropriate with Clinical Operations, Franchise and other BSDM functions;
• Provide leadership, direction and mentoring for their respective staff including staff personal development;
• Ensure all projects are adequately resourced to meet project deliverables and ensuring data management tasks remain on target to project timelines;
• Lead/approve CRF design, review and validation of the clinical database, including management of CRO activities in this area if required;
• Be responsible for approval of data management plans and other respective data management documentation as needed;
• Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;
• Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines, milestones, budgets. Will also ensure their team organizes and manages ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;
• Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;
• Be responsible for Identification and management of data handling processes for non-CRF data, including lab and image handling;
• Lead efforts co-ordinating with Medical Affairs organization as needed to facilitate data coding and safety reviews as needed;
• Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data management working