Senior Clinical Data Analyst

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 ;br>
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 Senior Clinical Data Analyst to join our MedTech 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

We are searching for the best talent for a Senior Clinical Data Analyst to join our MedTech 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 ;br>
Purpose:

Responsibilities include coordination of timelines and resources required to maintain a variety of clinical systems as well as coordinating all aspects of the development and management of clinical study databases across a variety of platforms. Coordination of activities will require the individual to leverage productive relationships with colleagues across the MD sector.

You will:

• Work with Data Management leadership to define and document data and process standards
• Create system deliverables for clinical trials
• Support the development and maintenance of global harmonized processes and procedures for system support
• Support vendor evaluation and selection for clinical systems (as needed)
• Work with BSDM partners, and leadership in Clinical Operations and Franchise to execute 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 change control of Interactive Voice/Web Response Systems (IxRS), Electronic Data Capture (EDC) Systems, CTMS, eTMF and other relevant systems for assigned studies
• Create, review and facilitate the approval system deliverables,
• Interface between Clinical R&D, IT and Quality including CSV regarding clinical systems, UAT, processes and other tools (as needed)
• Identify and escalate support requests associated with clinical systems
• Identify and escalate support requests for assigned clinical studies. Systems may include: CTMS, eTMF, IxRS, EDCs
• Assist with the implementation of system and study metrics
• Assist with the analyses and documentation of moderately complex change requests to determine feasibility for incorporation
• Escalates the review of vendor releases that address issues with current impacts
• 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 4 years of system support in clinical research within Medical Device or Pharmaceuticals
• Experience with at least one clinical system (Rave EDC, CTMS, or eTMF ) is preferred
• Previous experience in Clinical Operations preferred
• Medidata Rave EDC Developer Certification preferred
• Demonstrated ability to work in a team environment to deliver critical milestones
• Experience with CDISC STDM preferred
• Excellent verbal and written communication skills
• Knowledge of Google Cloud Platform and SDLC

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 () or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
$89,000-$140,000

Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below.