Johnson & Johnson Careers
Contracts & Grants, Clinical Trials Management Systems – Senior Technical Lead
Requisition ID: 1479180911
Janssen Research & Development LLC, part of the Johnson and Johnson family of companies, is currently recruiting for a Contracts & Grants, Clinical Trials Management Systems – Senior Technical Lead to be located in New Jersey, Pennsylvania or North Carolina.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologic (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
The Senior Technical Lead will be responsible for the Clinical Trials Management Systems (CTMS) template development and population as it relates to clinical trial payments. This individual will provide support to Contracts and Grants, business partners, and stakeholders in the use of CTMS in clinical trial payments.
- Attend weekly support meetings with Data Management, Pricing, Integrated Data Services, Business Support Team, and other business partners as needed to ensure proper study setup and cross functional alignment for integrated payments.
- Support training of study teams in regard to CTMS payment support and processes.
- Facilitate the collection of data to provide metrics on a designated basis to management.
- Support training of new Contracts & Grants CTMS Analysts.
- Support training and on-boarding for new CTMS (Payment Analyst) users.
- Assist Contracts and Grants and study team colleagues with complex CTMS issue resolution and/or guidance, as needed.
- Acts as lead point of contact for CTMS issues related to payments.
- Assist with UAT for new CTMS enhancements.
- Responsible for the population of country-specific and site-specific visit templates in CTMS for applicable countries.
- Support resolution of failed payments, as appropriate, for US purchase requisitions and other countries, as applicable.
- Collect site-specific fully negotiated financial exhibits for all sites participating in each country to apply/populate site-specific CTMS visit templates, as applicable.
- Track and maintain status of issues, study alignments, and country and site-specific financial exhibits in designated tracking system, as applicable.
- Attend ad hoc meetings with Contract and Grants Analysts to review and confirm current issues, status of ongoing issues, possible resolutions, and on-going efforts required for issue resolution.
- Confirm and initiate CTMS new user access requests and requests for additional modules, as necessary.
- Collaborate with business partners once Tagging/Integration files are complete to ensure proper setup of subject visit/activity templates in CTMS.
- Create and/or revise CTMS templates to support any necessary protocol revisions that may be required to support complex protocols.
- A minimum of a Bachelor’s degree is required, preferably in appropriate scientific or business disciplines
- A minimum of 3 years’ experience is required.
- Prior experience in the pharmaceutical/clinical research industry is highly preferred.
- Knowledge of the clinical development process is required
- A minimum of 2 years of payments/pricing/budgeting experience is required
- Experience working with Medidata CTMS and Medidata RAVE is required
- Excellent communication skills (both oral and written)
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is required
- Ability to work effectively in cross functional teams and various levels of the organization is required
- Strong analytical and problem resolution skills are required
- Working knowledge of PCs (MS Office suite at a minimum) and database management
- Must demonstrate ability to work in a fast-paced environment and to work independently
- Fluency in English is required
- Previous experience working in virtual teams is preferred
United States-New Jersey-Titusville
North America-United States-North Carolina, North America-United States-Pennsylvania
Janssen Research & Development, LLC. (6084)