Lead- Clinical Data Management

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

The Lead Clinical Data Manager will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. 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 Manager, Data Management this individual will:

• Mentor, train and supervise junior associates as needed in clinical data management processes and procedures
• 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 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
• Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
• Be responsible for identification of data handling processes for non-CRF data, including lab data and image handling
• Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets
• Lead efforts co-ordinating with Medical Affairs organization 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
• 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
• Perform other related duties as required.

Functional and Technical Competencies :

• 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).
• Excellent verbal and written communication skills.
• 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.
• Proficient-level data wrangling with R, Python and is experience with R Studio Connect app development.
• Proficiency in creating visualizations in Tableau.

EDUCATION & EXPERIENCE REQUIREMENTS:

• 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.

The anticipated base pay range for this position is $124,950 to $169,050.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• Employees are eligible for the following time off benefits:

  • Vacation – up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

  • Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below.

• The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.