Description
* Direct management of Clinical Operations functional area team(s)* Represent Clinical Operations as lead team members to cross functional project teams in Development Sciences
* Oversight of CROs as Relationship Managers and/or Operational Owners of clinical operations activities
* Program-specific leadership, guidance, clinical trial management expertise, and direction to achieve results
* Lead career planning and development activities for direct reports
* Performance management and effective coaching and training to achieve results
* Maintain metrics for Clinical Operations tasks and skills including processes, monitoring, and best practices
* Track data and trends on direct report job satisfaction, retention and productivity
* Recruit top talent and staff appropriates
* Liase with GCP Compliance on audit issues and inspection readiness activities
* Provide input on compliance with [company] and Development Sciences policies and procedures
* Assess quality of work for direct reports including monitoring visits, co-monitoring or oversight visits with CROs, data quality, and data clarification form managements, protocol deviation management, and planning and coordination of investigator meetings
* Develop Clinical Operations budget including resource needs and other functional budgets)
* Contribute to improvement of processes, systems, and tools as well as infrastructure within Clinical Operations
* Contribute to project clinical team meetings to provide timely and accurate operational updates, plans and recommendations
* Contribute to the development and review of Clinical Operations SOPs
* Provide input on clinical documents including protocols for content and accuracy
* Participate in standardization of tools within and across Clinical Operations programs