Senior Clinical Data Manager - JJMT Neurovascular

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 https://www.jnj.com

Job Function:

Data Analytics & Computational Sciences

Job Sub Function:

Clinical Data Management

Job Category:

Professional

All Job Posting Locations:

Albuquerque, New Mexico, United States of America, Albuquerque, New Mexico, United States of America, Anchorage, Alaska, United States, Atlanta, Georgia, United States, Austin, Texas, United States, Birmingham, Alabama, United States, Boise, Idaho, United States, Boulder, Colorado, United States, Burlington, Vermont, United States, Charleston, South Carolina, United States, Chicago, Illinois, United States, Concord, New Hampshire, United States, Detroit, Michigan, United States, Fargo, North Dakota, United States, Gulfport, Mississippi, United States, Honolulu, Hawaii, United States, Irvine, California, United States of America, Kansas City, Kansas, United States, Kansas City, Missouri, United States, Knoxville, Tennessee, United States, Las Vegas, Nevada, United States, Lexington, Kentucky, United States, Lincoln, Nebraska, United States, Little Rock, Arkansas, United States, Minneapolis, Minnesota, United States of America {+ 9 more}

Job Description:

Johnson & Johnson MedTech – Neurovascular division is currently seeking a Sr. Clinical Data Manager. This position is a remote position.

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.

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/

SUMMARY:

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.

POSITION DUTIES & RESPONSIBILITIES:

Reporting to the Manager, Data Management this individual will:

• 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 coordinating 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).

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.

REQUIREMENTS:

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

he anticipated base pay range for this position is $89,000 - $143,750

• The Company maintains a highly competitive sales incentive compensation program.  Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan.    
• This position is eligible for a car allowance through the Company’s Fleet program.
• 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)). 

·       This position is eligible to participate in the Company’s long-term incentive program.  

·       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 

·       Work, Personal and Family Time - up to 40 hours per calendar year 

Additional information can be found through the link below. 

 https://www.careers.jnj.com/employee-benefits

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 and 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, please email the Employee Health Support Center  (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$89,000 - $143,750

Additional Description for Pay Transparency:

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)). This position is eligible to participate in the Company’s long-term incentive program. 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. http://www.careers.jnj.com/employee-benefits