Job Description

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:

US180 CA Irvine - 29A Technology Dr

Job Description:

There is an internal pre-identified candidate for consideration. However, all applications will still be reviewed.

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

We are searching for the best talent for a Clinical Data Manager to be in Irvine, CA .

Benefits you will enjoy starting your first day:

• Competitive pay based on experience, night shift differential, plus an annual performance bonus.
• Full medical, dental and vision coverage, competitive 401k, HSA/FSA, and company paid Pension plan.
• 120 hours paid vacation, plus 40 hours paid sick leave and an additional 40 hours paid personal leave.
• Tuition Reimbursement for eligible degree programs.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting role!

As a Clinical Data Manager, you will:

OVERALL RESPONSIBILITIES:

The 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 / Lead Data Manager 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 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 including executive administration tasks such as supporting or assisting with PO creation, vendor management, coordinating task related to key opinion leader conference participation etc.

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.

EDUCATION & EXPERIENCE REQUIREMENTS:

• A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 2 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, please email the Employee Health Support Center ([email protected]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$74,000.00 - $119,600.00 USD Annually

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 For additional general information on Company benefits, please go to:

Job Tags

Holiday work, Permanent employment, Temporary work, Local area, Night shift,

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