Key Responsibilities and Major Duties
Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Monitors (CTMs) to ensure timely execution consistent with R&D and local research goals and priorities
Demonstrates the ability to effectively communicate with and influence individuals at all levels of the organization including situations of conflict resolution, problem solving and crisis management.
Anticipates resource needs and provides workload evaluations and task assignments
Allocates and assign study resources in alignment with R&D and local research goals and priorities.
Supervises clinical trial execution at country level including supervising study metrics, KPI and team performance
Approves study fee funds and payments based on grant of authority
May propose and/or validate country study targets
May support Health Authority inspection and pre-inspection activities
May support audit preparation & Corrective Action / Preventative Action preparation for local related issues
Develops goals that are consistent with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met
Together with the RCO management tracks and manages performance metrics for Clinical Operations staff
Anticipates and initiates action in response to multiple/changing demands and project priorities placed on Clinical Operations Unit
Point of Contact for FSP staff within the country
Managing the hiring, performance management and succession planning of staff
Performing general and human resource administrative functions
Participation in performance calibration and talent review meetings
Ensuring collaboration and information sharing with local country cross functional stakeholders (Medical, GRS, GPV, Market Access, Commercial, Human Resources)
Lead and contribute non study initiatives to optimized process and improve site management operation efficiency and productive.
When managing all RCO staff in a given country, will represent RCO in local leadership discussions at the affiliate level and may be member of the local affiliate leadership team managed by the General Manager
Ensure effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed
Manage partnerships with critical accounts / sites