Job Information
J&J Family of Companies Lead Clinical Database Programmer in Helena, Montana
Lead Clinical Database Programmer - 2306110130W
Description
Biosense Webster Inc. is recruiting for a Lead Clinical Database Programmer, located in Irvine, CA! Remote work options may be considered on a case by case basis if approved by the company!
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.
Key Responsibilities:
Collaborate with Data Management leadership (including Programming and Biostatistics) to define and document data and process standards
Provide in-house project support for creation, routing and approval of all system deliverables associated with clinical systems
Support the development and maintenance of global harmonized processes and procedures for system support
Support vendor evaluation, selection, contracting, and oversight activities for outsourced systems; Assist with vendor evaluation and selection activities for clinical systems
Work with BSDM partners, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines and milestones for study-specific systems set-up, UAT, maintenance and closeout as required
Lead project management activity related to the deployment of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant platforms (as assigned)
Create, review, and facilitate approval of system deliverables and facilitate appropriate quality review where applicable
Mentor peers through review of deliverables to minimize delays during the quality review process
Work cross-functionally with Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
Serve as first line of contact from study initiation through launch for each clinical study.
Facilitate the development of training materials and programs related to system set-up, UAT and ongoing maintenance as well as other relevant processes
Represent the Medical Devices Sector on Enterprise or cross-sector Clinical System teams (as needed)
Qualifications
Education:
- A Bachelor’s degree (or equivalent) in Statistics, Computer Science, or related field (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals.
Experience and Skills:
Required:
Proficient database builder in Medidata Rave
Experienced Custom Function developer
Demonstrated ability to manage a project in a team environment to deliver critical achievements
Excellent verbal and written communication skills
Knowledge of GCP
Preferred:
Previous experience in Clinical Operations
Knowledge of CDISC Standards
Familiarity with Medidate Rave Modules (ie. RTSM, Coder, tSDV)
Experience with integrations with CTMS
Other:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
The anticipated base pay range for this position is $102,000 to $163,300
The anticipated base pay range for the Bay Area of California is $116,700 to $187,795
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below:
https://www.careers.jnj.com/employee-benefits
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, m
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.
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.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com.
Primary Location NA-US-California-Irvine
Other Locations NA-United States
Organization Biosense Webster Inc. (6010)
Relocation Eligible: No
Travel No
Job Function Clinical Data Management
Req ID: 2306110130W