Clinical Operations Senior Manager

To lead and manage Clinical Research Associate function.

Key Responsibilities

• Supervises and coordinates the work assignments and performance of Clinical Research Associates (CRAs)

• 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 including supervising study metrics and team performance

• May approve 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 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

• Point of Contact for FSP staff within the country

• Managing the hiring, performance management and succession planning of employees

• Performing general and human resource administrative functions

• Participation in performance calibration and talent review meetings

• Ensuring collaboration and information sharing with cross functional stakeholders

• 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 / site

Minimum Requirements

• Bachelor’s degree required preferably within life sciences or equivalent.

• Minimum of 10 years pharmaceutical industry experience in clinical research

• Prior monitoring experience required

• • 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