J&J Family of Companies Senior Data Manager in Somerville, New Jersey
The Johnson and Johnson Medical Device (MD) Sector Clinical Research and Development Center of Excellence (CR&D COE) is recruiting for a Senior Data Manager located in Warsaw, IN (preferred)/ Somerville, NJ/ West Chester, PA/ Raynham, MA/ Irvine, CA/ Cincinnati, OH.
The MD CR&D COE is being created to support all clinical activities across all business units within the Johnson & Johnson Medical Device companies. The COE organization is based on three functional teams: Franchise, Operations and Biostatistics & Data Management. All three teams share accountability for the successful development and delivery of clinical evidence globally to internal and external (5Ps) stakeholders that drives innovation in surgical solutions and that optimizes the product lifecycle. Each team within CR&D COE will have primary responsibility for defined areas of clinical program development, execution and dissemination.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets.
Reporting to the Manager, data management this individual will;
Mentor, train and supervise junior associates as needed in clinical data management processes and procedures;
Independently lead a number of complex trials;
Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required;
Be responsible for creation of data management plans and other data management documentation as needed;
Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions;
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;
Proactively organize and manages ongoing data review throughout study conduct, 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 of data handling processes for non-CRF data, including lab data and image handling;
Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets;
Lead efforts co-ordinating with Medical Affairs organization 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 with the project leader data standards to implement;
Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;
Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;
Diligently participate in compliance program-related activities as denoted by the supervisor or Chief Compliance Officer;
Perform other related duties as required.
A Bachelor’s degree in life sciences, technical, or related discipline, with at least 4 years of clinical data management experience in Medical Device or Pharmaceuticals is required.
Experience of successful active participation in cross-functional teams is preferred.
Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery is preferred.
Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.) is required.
Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software is required.
Experience with Electronic Data Capture (EDC) is required. Medidata RAVE preferred.
Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug) is preferred.
Travel up to 10%.
North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West Chester, North America-United States-California-Irvine, North America-United States-Massachusetts-Raynham, North America-United States-New Jersey-Somerville
Depuy Orthopaedics. Inc. (6029)
Clinical Data Management