The Manager, Supply Chain Oversight (GCO) serves as a key resource and expert for Global Clinical Operations to interface between internal lines and external partners/customers as it relates to clinical drug supply and non-clinical supply (Supplies) for the portfolio of clinical studies managed by GCO.
In this role, the selected candidate oversees data validation efforts, including plan and report generation, staff training, validation oversight and corrections, manages DSMB/CECs, including member identification/qualification, SOP and Plan development, meeting preparation, management and follow-up.
The Senior Clinical Operations Manager (Sr. COM) is responsible for the day-to-day leadership and management of clinical monitoring services for a portfolio of projects, including direct communication and interaction with monitors/investigative sites and the Sponsor.
In this role, the selected candidate will provide oversight of delegation of the assessment and reassessment of patients, including updating of care plans and interpreting patient needs, while adhering to Company, physician, and/or health facility procedures/policies.
In this role, you will be responsible for supporting and driving quality standards through meeting all ESRD regulatory requirements and the practice of Quality Assessment and Improvement (QAI), including use of QAI tools.
In this role, you will lead in performance improvement activities, maintains ongoing clinical knowledge through internal/external training programs, provide interpretation of knowledge and direction to staff.
In this role, you will be responsible for the successful planning, implementation and execution of contracted clinical monitoring activities. Functionally responsible for all clinical monitoring team members throughout the duration of each clinical trial.
As a clinical supervisor of our hemodialysis team, the natural leader we select will provide direction, inspiration, and counseling to staff members, and coordinate all aspects of care, from admission to discharge.