The Head of Country Operations (HCO) will build and lead a local team fully accountable for all study deliverables and quality within their country. The HCO is accountable for all assigned operational trial deliverables across programs are completed according to timelines, operational procedures, quality standards, SOPs and guidelines. Focus is on high quality delivery in a time and cost effective manner, in accordance with local regulations and ICH/GCP guidelines.
The Head Country Operations is a key contributor in the overall deliverables for the country, including enrollment numbers, site numbers, site selection, etc. and will be in equal partnership with the global study team to define those deliverables.
The Head of Country Operations will play a central role in establishing and maintaining
oversight and effective management of vendors inlcuding CROs and will create an effective communication pathway with other stakeholders within their country e.g. Local Medical Affairs and Legal (where applicable).
Job Accountabilities & Responsibilities
Reporting to the Regional Head Country Operations (RHCO) the HCO is
- Building a scalable local country operations group to deliver on clinical programs from Phase I to III
- Quality and timeliness of all study deliverables (site identification, feasibility, start up, recruitment , data deliverables) in assigned country. Meeting recruitment targets for all studies in assigned country.
- Quality of monitoring oversight, completeness of CDA coverage, creating accurate study budgets across all studies
- Monitoring metrics and Key Performance Indicators (KPIs) across all studies in assigned country
- Ensuring Project Managers Country Operations (PMCOs) are proactively communicating with Study Leads Country Operations (SLCOs) to report study specific issues
- Staff management, people development, resource management, succession planning and team leadership
- Approving ICF adaptations made by the CRO or PMCO
- Approving Ethics Committee submissions and approvals
- Approving site selections for each study in assigned country
- Management of site relationships
- Ensuring that a post trial acess plan is in place at the country level
- Compliance of local employees and contract workers (under FSP) with Alexion SOPs
- Proactively connecting with other country heads to share issues and learnings to ensure coordination
- Liaise and coordination with in-country / regional Medical Affairs
- Escalation of changes to work orders /budget to Centre of Operating Excellence (COE)
- Once CTMS is implemented, escalating changes to country work orders / country budgets to the appropriate party
- Develops expertise in analyzing and resolving issues relating to study execution and compliance
- Ensure that country operations teams are appropriately qualified and trained for the roles they undertake
- Drive continuous improvement and organizational performance via global performance metrics ensuring high quality delivery
- Identify performance issues and/or areas of opportunity for continuous improvement
- Ten plus 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 global clinical trials. Proven excellence in operational strategy and delivery of clinical operations activities across multiple projects.
- Experience leading, developing and implementing functional and cross-functional teams, SOPs and processes
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines
- Demonstrated proficiency in the implementation, monitoring and management of clinical trials
- 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
- Ability to establish excellent internal and external relationships, including alliance partners and vendors
- Strong planning and budgeting skills
- Superior written, oral and presentation skills
- Ability to lead in a matrix environment
- 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 upon progress of programs
- Previous field CRA experience
- Experience with partnering and managing CRO relationships
- Experience in 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.
- Masters or Doctoral degree or equivalent in a scientific discipline