Senior Clinical Data Manager

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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:

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

 

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

 

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

 

We are searching for the best talent for Senior Clinical Data Manager.

 

Purpose: The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. 

 

You will be responsible for:

 

• Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required; 
• Have the ability to support a number of moderate complexity / complex trials with minimal supervision; 
• Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight; 
• Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to  ensure all remain on target to project timelines; 
• Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects; 
• Be responsible for participating in 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 handling of non-CRF data, including lab data and image handling; 
• Be responsible for co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed; 
• Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed; 
• 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 our Chief Compliance Officer; 
• Performs other related duties as required. 

 

Functional and Technical Competencies: 

 

• Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery. 

• Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc). 

• Strong 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). 

• Desired a proficient-level skills in writing and optimizing SQL queries. 

• Familiar with Big Data technologies such as AWS services, Lambda, Glue, orchestration etc. 

• Desired a proficient-level data wrangling with R, Python and is experience with R Studio Connect app development. 

• Desired a proficiency in creating visualizations in Tableau. 

 

Leadership Competencies: 

 

• Connect  - Cultivate relationships with key internal  stakeholders to ensure projects remain on target to project timelines. 

• Shape – Develop knowledge of therapeutic areas within the Franchises. 

• Lead – Active participation as data management representative on project teams to ensure deliverables are met. 

• Deliver – ensure projects are delivered on time, within budget and in compliance to regulations and SOPs. 

 

 

Qualifications / Requirements:

• A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline
• 4 years of  clinical data management experience in Medical Device or Pharmaceuticals .
• Experience of supporting trials with minimal supervision. 

 

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

 

#LI-Hybrid

Required Skills:

 

 

Preferred Skills:

Advanced Analytics, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Communication, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Organizing, Problem Solving, Report Writing, Standard Operating Procedure (SOP), Systems Analysis

 

 

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).​

This position is eligible to participate in the Company’s long-term incentive program.​
​
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:​

Vacation –120 hours per calendar year​
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year​
Holiday pay, including Floating Holidays –13 days per calendar year​
Work, Personal and Family Time - up to 40 hours per calendar year​
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child​
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year​
Caregiver Leave – 80 hours in a 52-week rolling period10 days​
Volunteer Leave – 32 hours per calendar year​
Military Spouse Time-Off – 80 hours per calendar year​

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits​