Responsible for themCTMS template development and population as it relates to clinical trial site and related payments. Provide support to Contracts and Grants, business partners, and stakeholders in the use of mCTMS in clinical trial payments.
Support training of study teams in regards to mCTMS payment support that can be provided and the specific processes.
Facilitates the collection of data in order to provide metrics on a designated basis to management.
Support training new Contracts & Grants mCTMS Analysts
Support training and on-boarding for new mCTMS (clinical trial payments) users
Assist Contracts and Grants and study team colleagues with complex mCTMS issue resolution and / or guidance, as needed.
Responsible for the population of country-specific or site-specific visit templates in mCTMS for applicable countries.
Answer queries, questions and issue resolution with sites and study team, as needed.
Support resolution of failed payments, as appropriate, for US purchase requisitions.
Collect site-specific fully negotiated financial exhibits for all sites participating in each country to apply / populate site-
specific CTMS visit schedule where appropriate
Track and maintain status of country-specific and site-specific financial exhibits in designated tracking system, as needed.
Attend weekly support meetings : Data Management, Pricing, Integrated Data Services, Business Support Team, and to ensure study setup and cross functional alignment is as expected for each team.
Attend ad hoc meeting with contract and grants analysts to review and confirm current issues; discussion includes new issues, issue status, possible resolutions, and required on-
going efforts for issue resolution.
Confirm and initiate user access requests and additional modules for CTMS users as necessary.
Collaborate with clinical operations group once Tagging / Integration file is complete for protocol
Create and / or revise templates for CTMS users to support any necessary protocol revision that may need to be developed for current complex protocols.
Bachelor’s degree, or equivalent, in appropriate scientific or business disciplines
3- 5 years experience and / or equivalent competencies in pharmaceutical industry / clinical research
Must have a working knowledge of the clinical development process with 2 years of pricing / budgeting or negotiation and contract experience
Experience working with IMS GrantPlan system or Medidata Grants Manager system is preferred
Excellent communication skills (both oral and written)
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.
Ability to work effectively in cross function teams in various levels of the organization
Strong and proven negotiation and problem resolution skills
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 preferred