The Senior Project Manager will lead the cross functional project teams including clinical operations, data management, biostatistics, medical writing and clinical QA, to ensure quality, on-time and within budget deliverables for primarily Phase II-IV clinical trials.
In this role, you will managing the clinical study timelines, deliverables and risks, working with the client and Business Services to finalize the project budget and scope, serving as primary contact with client to ensure appropriate communication, managing project budget, and participate in internal and external meetings.
This position will be critical to managing the
imperative that CHRISTUS prioritize, anticipate and address overlapping initiatives and
subsequent concerns related to resource allocation, budgeting, and attestation timelines.
In this role, the selected candidate will be responsible to work with team leaders to help create detail project plans that the team leaders can revise as appropriate to meet changing needs and requirements.
Responsible for supporting and driving FMS quality standards through meeting all ESRD regulatory requirements and the practice of Quality Assessment and Improvement (QAI), including use of FMS QAI tools.
In this role, the selected candidate will manage successful execution of assigned global clinical studies in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs) as applicable to United States Food and Drug Administration (FDA) regulations, Health Canada, International Conference on Harmonization (ICH) guidelines and any other applicable guidelines and regulations.