Senior Manager – Clinical Data Management – R&D

Xplore Pharma
We are recruiting for a Senior Clinical Data Manager for work with a leading American Professional Services Company within the Clinical Domain. Location will be based out of offices in New Jersey, however remote working will be possible working out of EST timezone. The role will lead & support projects involving the implementation of Clinical data standards, Clinical Analytics capability, Clinical Trial Management processes & systems. Experience & Skills: Expertise within the Clinical domain – data standards, business processes, systems & technology Good experience with patient data in clinical R&D space Experience in CDISC standards: CDASH, SDTM, ADaM Experience in working in patient data warehouse Strong communication skills and ability to lead conversations with business/IT stakeholders and related vendors Project management skill is a plus Communicates & collaborates effectively with different groups both on the business & IT side, including senior stakeholders – ability to articulate complex scenarios succinctly and targeted to the group Ensure customer success throughout the engagement Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines Expert in life sciences compliance and computer systems validation requirements Desired Platform knowledge: • Oracle Life Sciences Data Hub (patient data repository), Oracle BI for patient data analytics, JReview for patient data reports, SAS Grid (ADaM and TLF generation), CONFORM (SDTM generation), Axway ST (external vendor data integration), Pinnacle 21 for generating metadata (define.xml) and Eclipse Coding Tool for medical coding, Veeva Vault CTMS, eTMF