Lead Clinical Data Analyst at Johnson & Johnson

Cincinnati, Ohio, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, MedTech, PharmaceuticalsIndustries

Requirements

Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required
Previous experience in Clinical Operations preferred
Demonstrated ability to manage projects with little to no supervision

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 work and facilitate appropriate quality review where applicable
Mentor peers through review of deliverables to minimize delays during the quality review process
Coordinate between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools
Facilitate support requests associated with clinical systems (as needed)
Serve as first line of contact from study initiation through launch for each clinical study. Systems may include: CTMS, eTMF, IxRS, EDCs
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)
Assist with the implementation of study metrics
Analyze complex change requests to determine feasibility for incorporation within clinical studies
Evaluate vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters
Coordinate timelines and resources required to implement and maintain a variety of clinical systems
Provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms
Develop strong, productive relationships with colleagues across the MD sector

Skills

Clinical Data Management

Data Analytics

Database Management

Biostatistics

Programming

Data Standards

Project Coordination

Clinical Systems

Johnson & Johnson

Healthcare products in pharmaceuticals and devices.

About Johnson & Johnson

Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.

New Brunswick, New JerseyHeadquarters

1886Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

J&J faces a class action lawsuit in Australia over ineffective cold and flu medications.

Former J&J executives joining other firms could lead to increased competition.

Ongoing legal battles, like the lawsuit against Cigna, pose financial liabilities for J&J.

Differentiation

J&J operates in three segments: pharmaceuticals, medical devices, and consumer health.

The company invests heavily in R&D for innovative medical solutions and products.

J&J is committed to diversity, equity, and inclusion in its workplace culture.

Upsides

J&J's collaboration with Helsinki University Hospital focuses on value-based healthcare models.

The rise of personalized medicine offers J&J opportunities in targeted therapies.

Increased focus on digital health solutions presents expansion opportunities for J&J.

Land your dream remote job 3x faster with AI

Try Jobo Free