Johnson & Johnson Careers
Lead Clinical Data Manager
Irvine, California; Warsaw, Indiana; Somerville, New Jersey; Raynham, Massachusetts; Cincinnati, Ohio
Clinical Data Management
Requisition ID: 0195190325
Medical Device Business Services Inc (a Johnson and Johnson company) is recruiting for a Lead Clinical Data Manager, located in any of our existing medical device locations (Raynham MA, Warsaw IN, Cincinnati OH, Somerville NJ, Irvine CA (preferred)).
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
The Lead Clinical Data Manager is a key player in a cross functional team leading all aspects of study execution. S/he ensures clinical trial data collected meet the highest standards of data integrity, while maintaining metrics, meeting timelines and adhering to study budgets. Responsibilities include:
- Independently lead several complex trials in a variety of study phases (e.g. First in Man, Investigational Device Exemption, post market surveillance);
- Mentor, train and oversee junior associates regarding processes and procedures associated with study start up, execution and completion;
- Lead study level CRF design, review and validation of clinical database, including management of CRO activities;
- Independently maintain all study level documentation including data management plans, specification documents and evidence of completed review processes;
- Lead, oversee, facilitate and manage all data management activities from initiation of protocol through database lock,
- Accountable for the identification and correction of errors and data discrepancies for the life of a project;
- Define and document study specific data handling processes for non-CRF data, including lab data and image handling;
- Independently lead new data management initiatives and contribute towards process improvement and data standards;
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of integrity, ethics and compliance at all times;
Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline is preferred.
Minimum of 6 years of clinical data operations experience in Medical Device or Pharmaceuticals including active participation in cross-functional teams is required.
- Therapeutic area knowledge in at least one of cardiovascular, neurovascular, ophthalmology or general surgery is required, Neurovascular is preferred.
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software is required.
- Experience with Electronic Data Capture (EDC) required, Medidata RAVE is preferred.
- Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug) is required.
- Knowledge of CDISC SDTM is preferred.
- Knowledge of reporting or data analysis tools (e.g. SAS, Business Objects, J-Review) is preferred.
Proficient in English, written and oral is required.
Occasional travel (less than 10%) is required.
Certified Clinical Data Manager is preferred.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
North America-United States-Indiana-Warsaw, North America-United States-New Jersey-Somerville, North America-United States-Massachusetts-Raynham, North America-United States-Ohio-Cincinnati
Depuy Orthopaedics. Inc. (6029)
Clinical Data Management