Supervises and coordinates the work assignments and performance of Clinical Trial Monitors (CTMos), to ensure timely execution consistent with RD 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 RD and local research goals and priorities.
Supervises clinical trial execution at country level including supervising study metrics 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
Ensure Study Corrective Action / Preventative Action (CAPA) implementation and ensure the necessary resources / tools are available
Develops goals that are consistent with RD 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)
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
Qualification and experience:
Bachelors required preferably within life sciences or equivalent
Minimum of 5 years Pharmaceutical industry experience in Clinical Research
Prior monitoring experience required
Significant experience in the planning, conduct and management of clinical programs (Phase I-IV)
Demonstrated ability to drive project related activities
Previous supervisory and/or leadership experience (i.e. participation in task force, initiative or cross functional team)
Previous resource allocation experience preferred
Experience mentoring and providing feedback to others
