Senior Clinical Operations Manager

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Position Summary

To lead and manage a cross functional Clinical Operations Unit, ensuring delivery of clinical operations effectiveness in RCO-US.

Key Responsibilities

• Supervises and coordinates the work assignments and performance of Clinical Operations staff inclusive of Clinical Trial Managers (CT Mgrs), Clinical Trial

• Monitors (CTMs), Clinical Trial Associates (CTAs), Site Relationship Managers, Study Start-up Specialists and/or Site Contract Leads 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 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 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)

• 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

Qualifications & Experience

• Bachelors required preferably within life sciences or equivalent

• Minimum of 5 years Pharmaceutical industry experience in Clinical Research or Medical Affairs

• For CT Monitor Line Managers – 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

Competencies