Ref #: 33508
Employment type: Permanent - Full-Time
Location: Poland
Posted: 31-May-2022
Description
Contract & Compliance Services (CCS)
Global or Regional Applicability:
Global
Services Overview:
Develop and populate template that relates to clinical trial payments in the Clinical Trial Management System
(CTMS). Provide support to Contract & Compliance Services (CCS), business partners, and stakeholders in the
use of CTMS in clinical trial payments.
Deliverables:
• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory
requirements, etc.
• Ensure proper study setup and cross functional alignment for integrated payments, deliver services
including attend meetings with Data Management, Pricing, Integrated Data Services, Business
Support Team, and other business partners as needed.
• Support training of study teams in regard to CTMS payment support and processes.
• Facilitate the collection of data in order to provide metrics on a designated basis to management.
• Support training and onboarding for new CTMS (Payment Analyst) users.
• Assist CCS and study team colleagues with complex CTMS issue resolution and/or guidance, as
needed.
• Assist with UAT for new CTMS enhancements.
• Populate country-specific and site-specific visit templates in CTMS for applicable countries including
collecting site-specific fully negotiated financial exhibits for all sites participating in each country.
• Support resolution of failed payments, as appropriate, for US purchase requisitions and other
countries, 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 business partners 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.
• Other deliverables related to the function may be assigned.
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP)
document.
----------------------------------------------------------------------------------------------------------------------------------------------------
Version 1.1 dated 14 JUL 2020
1-supply/JJEDS: Role = Technical Lead; Possible Position titles: Technical Lead
Page 1 of 2
Interfaces – Primary/Other:
• Primary interfaces: Interface with internal Business Partners (CCS, TA, MAF, MAO, GCDO, JRP, HCC,
Risk Management, Legal, etc.) outside parties such as Clinical Investigator Sites, Commercial
Suppliers, and Clinical Research Organizations (when applicable).
Education and Experience Requirements:
• Bachelor’s degree, or equivalent, in appropriate scientific or business disciplines.
• 3-5 years’ experience and/or equivalent competencies in pharmaceutical/clinical research industry.
• Working knowledge of the clinical development process with at least 2 years of
payments/pricing/budgeting experience.
• Experience working with Medidata CTMS and Medidata RAVE.
• Excellent communication skills (both oral and written).
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbour,
etc.).
• Ability to work effectively in cross-functional teams and various levels of the organization.
• Strong analytical and problem resolution skills.
• Working knowledge of PCs (MS Office suite at a minimum) and database management.
• Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish
substantial tasks with minimal supervision.
• Fluency in English.
• Previous experience working in virtual teams.
#technical lead
Global or Regional Applicability:
Global
Services Overview:
Develop and populate template that relates to clinical trial payments in the Clinical Trial Management System
(CTMS). Provide support to Contract & Compliance Services (CCS), business partners, and stakeholders in the
use of CTMS in clinical trial payments.
Deliverables:
• Services rendered will adhere to applicable Johnson & Johnson SOPs, WIs, policies, local regulatory
requirements, etc.
• Ensure proper study setup and cross functional alignment for integrated payments, deliver services
including attend meetings with Data Management, Pricing, Integrated Data Services, Business
Support Team, and other business partners as needed.
• Support training of study teams in regard to CTMS payment support and processes.
• Facilitate the collection of data in order to provide metrics on a designated basis to management.
• Support training and onboarding for new CTMS (Payment Analyst) users.
• Assist CCS and study team colleagues with complex CTMS issue resolution and/or guidance, as
needed.
• Assist with UAT for new CTMS enhancements.
• Populate country-specific and site-specific visit templates in CTMS for applicable countries including
collecting site-specific fully negotiated financial exhibits for all sites participating in each country.
• Support resolution of failed payments, as appropriate, for US purchase requisitions and other
countries, 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 business partners 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.
• Other deliverables related to the function may be assigned.
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP)
document.
----------------------------------------------------------------------------------------------------------------------------------------------------
Version 1.1 dated 14 JUL 2020
1-supply/JJEDS: Role = Technical Lead; Possible Position titles: Technical Lead
Page 1 of 2
Interfaces – Primary/Other:
• Primary interfaces: Interface with internal Business Partners (CCS, TA, MAF, MAO, GCDO, JRP, HCC,
Risk Management, Legal, etc.) outside parties such as Clinical Investigator Sites, Commercial
Suppliers, and Clinical Research Organizations (when applicable).
Education and Experience Requirements:
• Bachelor’s degree, or equivalent, in appropriate scientific or business disciplines.
• 3-5 years’ experience and/or equivalent competencies in pharmaceutical/clinical research industry.
• Working knowledge of the clinical development process with at least 2 years of
payments/pricing/budgeting experience.
• Experience working with Medidata CTMS and Medidata RAVE.
• Excellent communication skills (both oral and written).
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbour,
etc.).
• Ability to work effectively in cross-functional teams and various levels of the organization.
• Strong analytical and problem resolution skills.
• Working knowledge of PCs (MS Office suite at a minimum) and database management.
• Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish
substantial tasks with minimal supervision.
• Fluency in English.
• Previous experience working in virtual teams.
#technical lead