Director, Country Operations Management

About the role

The Director Country Operations Management (DCOM) will lead a local execution team, fully accountable for all study deliverables and quality for programs in their country. The DCOM is accountable for execution of all assigned operational trial deliverables, for assigned programs completed according to timelines, operational procedures, quality standards, SOPs and guidelines.

Responsibilities

• Leads local execution team for assigned programs consistent with country level ways of working
• Utilizes available technology proficiently to manage local study delivery and identify opportunity for operational optimization
• Directs country execution team to achieve quality and timeliness of all study deliverables (site identification, feasibility, start up, recruitment, data deliverables)
• Ensures resource optimization of assigned team to deliver to committed clinical program targets
• Develops and performs management of direct reports and ensures each direct report has development and training plans according to company policy and people plans
• Hands-on support and coaching direct line reports on a regular basis to address challenges and needs
• Participates in succession planning and talent development discussions
• Prepares salary and bonus proposals for direct reports based on their performance, in close consultation with SDHCO and local HRBPs
• Contributes to transformation initiatives, shapes processes to standardize ways of working country level, and manages change to ensure contribution to effective COM organization
• Makes sure to monitor metrics and Key Performance Indicators (KPIs) across all studies
• Ensures cross-functional collaboration of team and PMCOs through proactive communication with global study team members (Global Study Directors, Global Study Associate Directors, Global Study Managers), and other local study team members (Study Start-up Managers, Site Contract Associate Directors, Site Alliance Lead, Site Solutions Manager, CRAs, and ADCOM)
• Partners with Development Country Quality and Medical Advisor Pipeline to ensure quality mindset, and Inspection Readiness, and management of site engagement, respectively
• Contributes to high quality re/feasibility work, using data driven approach balanced with local intelligence and site insights to develop credible plans and country commitments for assigned projects, and in accordance with country goals
• Oversees local team member interactions with IRB/Ethics Committees
• Affirms timely completeness of the eTMF
• Affirms that a post-trial access plan is in place as part of study completion
• Ensures compliance of local study team and contract workers (including FSP) with Alexion SOPs
• Proactively connects with other Country leaders to share issues and learnings to ensure overall success of COM organization
• Manages internal and external stakeholders, and supports local strategies within country and working in collaboration with local Medical Affairs, Regulatory, and AZ SMM colleagues
• Effectively manages risks, issues, decisions at the country and local study level; escalates to SD HCO appropriately
• Develops expertise in analyzing and resolving issues relating to study execution and compliance in fast evolving clinical trial landscape
• Ensures that respective execution teams are appropriately qualified and trained for the roles they undertake
• Drives continuous improvement and team performance monitored via global, regional and country performance metrics ensuring high quality delivery
• Identifies performance issues and/or areas of opportunity for continuous improvement

Requirements

• Minimum 7 years of clinical research experience with experience in the development & management of a clinical operations function and management of staff in a pharmaceutical and/or biotechnology environment
• Experience with internal delivery of global clinical trials
• Proven excellence in operational delivery of clinical operations activities across multiple projects
• Previous line management experience (direct lines)
• Experience leading, developing and implementing functional and cross-functional teams, SOPs and processes
• Deep knowledge of global regulatory requirements and ICH/GCP guidelines
• Demonstrated proficiency in the implementation, monitoring and management of clinical trials
• Deep knowledge of respective TA operational delivery, country environment for clinical trials, and rare disease landscape
• Demonstrated ability to prioritize, meet deadlines and manage competing priorities and changing demands
• Demonstrated ability to build, coach, mentor, motivate and supervise a high performing team in a dynamic company, including ability to clarify roles and responsibilities
• Established excellent internal and external relationships, including alliance partners and vendors
• Strong planning and budgeting skills
• Superior written, oral and presentation skills
• Excellent project management and administrative skills
• Excellent interpersonal skills across countries, cultures and organizational functions. Well-developed problem solving, organizational, and negotiating skills
• Available for domestic and international travel up to 25%, dependent on progress of programs

Qualifications

• Bachelor’s level degree required
• Preferred Qualifications: Previous field CRA experience, Experience running clinical studies for ultra-rare diseases and capability to develop and implement innovative solutions for optimizing the conduct of ultra-rare disease studies, Experience of adult and pediatric clinical research in various therapeutic areas in the US, Masters or Doctoral degree or equivalent in a scientific discipline