Biosense Webster, Inc., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Manager, Data Management to be located in Irvine, CA, San Diego, CA, South San Francisco, CA OR Seattle, WA.
Consideration will also be given to candidates able to work remotely in the Pacific or Mountain Time Zone of the United States.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
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 CSS group of companies. 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 Associate 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, Biostatistics and Programming 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 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 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;
- Participate in vendor evaluation, selection, contracting, and oversight activities for Clinical Data Management including any offshore vendors;
- Work proactively with the clinical systems lead(s) as needed to ensure effective processes and communications;
- 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;
- Performs other related duties as required.
Functional And Technical Competencies
- History of leading project teams to deliver excellent quality results.
- Excellent verbal and written communication skills.
- Knowledge of GCP, CDASH/CDISC 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).
- Minimum of a Bachelors’ Degree in the Biological Sciences, Computer Science or related discipline with at least 8 years of clinical data management experience in Medical Device or Pharmaceuticals is required.
- 1 year supervisory experience is required
- Experience with SQL or database query is preferred.
- Project Management experience is preferred.
- Experience with SAS or R Studio 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 based on disability.
United States-California-Irvine-29A Technology Dr
North America-United States, North America-United States-California-South San Francisco, North America-United States-Washington-Seattle, United States-California-San Diego
Biosense Webster Inc. (6010)