Johnson & Johnson is looking for a Lead Clinical Data Manager to ensure the highest standards of data integrity for clinical trials, meeting timelines and budgets, and to lead data cleaning and quality review processes.
Requirements
- Therapeutic area knowledge in at least one of cardiovascular, Neurovascular, or general surgery.
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc).
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
- Experience with Electronic Data Capture (EDC), Medidata RAVE preferred.
- Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
- Proficient-level skills in writing and optimizing SQL queries.
- Familiar with Big Data technologies such as AWS services, Lambda, Glue, orchestration etc.
Responsibilities
- Independently lead several 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 the 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
- Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling
Other
- Mentor, train and supervise junior associates as needed in clinical data management processes and procedures
- Excellent verbal and written communication skills.
- A Bachelor’s degree (or equivalent) in biological sciences, Computer Science or related discipline, with at least 6 years of clinical data management experience in Medical Device or Pharmaceuticals including experience of successful active participation in cross-functional teams.
- 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
