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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:

Cincinnati, Ohio, United States of America, Remote (US)

Job Description:

Johnson & Johnson is recruiting for a **Lead Clinical Data Analyst​** to join our MedTech Surgery business.

This is a remote role available in all states/cities within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

OVERALL RESPONSIBILITIES:

Responsibilities include coordination of timelines and resources required to implement and maintain a variety of clinical systems as well as provide oversight and coordination of all aspects of the development and management of clinical study databases across a variety of platforms. Coordination of activities will require the development of strong, productive relationships with colleagues across the MD sector. This individual performs with little to no supervision.

POSITION DUTIES & 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;

+ Analyzes complex change requests to determine feasibility for incorporation within clinical studies;

+ Evaluates vendor supplied release documentation for implementation feasibility and collaborate with appropriate partners to define project parameters;

Functional and Technical Competencies** **:

+ Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required;

+ Previous experience in Clinical Operations preferred;

+ Demonstrated ability to manage a project in a team environment to deliver critical milestones;

+ Strong proficiency in more than one Clinical system. Advanced certification preferred;

+ Experience with CDISC STDM preferred;

+ Excellent verbal and written communication skills;

+ Knowledge of GCP and SDLC;

Leadership Competencies** **:

+ Connect – Support strategic partnerships with Clinical System and IT leaders at the Enterprise level to ensure MD sector needs are communicated and understood, and with franchise and clinical operations leaders to ensure effective implementation and utilization of systems within the Clinical R&D CoE

+ Shape – Develop knowledge of therapeutic areas within the Franchises and adapt ADaM and STDM standards for medical devices for use in the MD sector; participate in industry initiatives to define/refine STDM standards

+ Lead – Mentor team mates to ensure consistency in process execution and quality system execution

+ Deliver – ensure upgrades and maintenance of clinical systems are delivered on time, within budget and in compliance to regulations and SOPs, seamlessly across all Franchises

EDUCATION & EXPERIENCE REQUIREMENTS:

+ A Bachelor’s degree (or equivalent) in Statistics, Computer Science or related subject area (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals.

Benefits Summary:

+ 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 & 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._

Required Skills:

Preferred Skills:

Database Development