Associate Director, Clinical Operations - Southeast Region

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Position Summary

The Associate Director, Regional Clinical Operations (RCO) -Southeast Region is a senior leadership role within the RCO organization providing functional, strategic or country level leadership.

Key Responsibilities

• Provides functional, strategic or country leadership

• Supervises and coordinates work assignments and performance of RCO staff inclusive of Clinical Trial Managers (CTMs), Clinical Research Associates (CRAs), Country Coordinators (CCs), Site Contract Leads (SCLs) and/ or Trial Managers – Late Development (TM-LD) and Trial Specialists – Late Development (TS-LD) to ensure timely execution consistent with R&D and local research goals and priorities

• Effectively communicates with and influences 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 assigns study resources at the cross functional/functional unit level 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 and may approve site contracts

• May propose and/or validate country study targets

• May support Health Authority inspection and re-inspection activities  

• May support audit readiness activities, and the development and implementation of Corrective and Preventative Actions (CAPAs) for identified issues, also ensuring the necessary resources / tools are available  

• Develops goals aligned with R&D and local research goals and priorities and takes necessary actions to ensure that goals are met

• Manages performance metrics for Clinical Operations staff  

• Anticipates and initiates action in response to multiple/changing demands and project priorities placed on RCO organization and team  

• May act as a Point of Contact for FSP staff within the country  

• Manages the hiring, performance management and succession planning of staff

• Performs general and human resource administrative functions  

• Participates in performance calibration and talent review meetings

• Ensures collaboration and information sharing with local country cross functional stakeholders (Medical, GSR, GPV, Market Access, Commercial, Human Resources)

• May represent RCO in local leadership discussions at the Affiliate level 

• Ensures effective external partnerships with Study Sites, Investigators, Pharma Trade Associations, Ministry of Health and /or Heath Authorities as needed  

• May manage partnerships with critical accounts / sites and supervise other line manager(s) within Regional Clinical Operations

Qualifications & Experience

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

• Approximately 10 years’ experience in pharmaceutical or relevant industry, including extensive experience in people management

• Previous experience leading, managing, coaching and developing people and teams

• Strong understanding of Clinical Research

• Demonstrated experience in the planning, conduct and management of clinical programs (Phase I-IV)

• Demonstrated ability to drive project related activities  

Competencies

• In depth understanding of GCP, ICH Guidelines and other local guidance, regulation and codes o