Clinical Database Programmer-EDC

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:

Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

We are searching for the best talent for a Lead Clinical Database Programmer with EDC to join our DePuy Synthes team located in Warsaw, IN; Raynham, MA; or West Chester, PA;

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

Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

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

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. 

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Purpose: The Lead Clinical Data Analyst will coordinate 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.  

You will:

• 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 deliverables and facilitate appropriate quality review where applicable
• Mentor peers through review of deliverables to minimize delays during the quality review process
• Interface 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 go live 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
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Qualifications: 

• A Bachelor’s degree (or equivalent) in Statistics, Computer Science or related discipline (required), with at least 6 years of system support in clinical research within Medical Device or Pharmaceuticals
• Experience with at least one clinical system (EDC, CTMS, eTMF and IxRS) is required; Strong proficiency in more than one Clinical system preferred. Advanced certification preferred
• Demonstrated ability to manage a project in a team environment to deliver critical milestones required
• Must have proven experience with Medidata or Veeva systems   
• Excellent verbal and written communication skills required
• Previous experience in Clinical Operations preferred
• Experience with CDISC STDM preferred
• Knowledge of GCP and SDLC preferred
• Travel up to 10%

#LI-AM2

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

Required Skills:

 

 

Preferred Skills:

Advanced Analytics, Clinical Data Management, Clinical Operations, Collaboration, Communication, Database Management, Data Quality, Data Savvy, Good Clinical Practice (GCP), Innovation, Interdisciplinary Work, Problem Solving, Process Improvements, Research Ethics, Resource Allocation, Training People

 

 

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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