Director, Country Operations Management

AstraZeneca•Boston, MA

20h•$162,566 - $243,850•Hybrid

About The Position

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. Focus is on high quality delivery in a timely and cost-effective manner, in accordance with local regulations and ICH/GCP guidelines, and as aligned with country level ways of working. The DCOM is a key contributor in the overall deliverables for the country, including early planning, feasibility, site selection, study start-up, enrollment, data deliverables, and close-out, and works in partnership with global study team, SDHCO, Dir SSU and Site Partnership, and RHCO to define those deliverables. DCOM is accountable for leading, managing, training, and developing a dedicated team of direct reports, and is responsible for planning and optimization of reporting resources including objective setting, performance follow-up, and contributes to shaping processes to standardize ways of working country level and managing change . The DCOM will play a central role in maintaining oversight and effective management of vendors including CROs and will create an effective communication pathway with other stakeholders within their country e.g. Local Medical Affairs and Legal (where applicable).

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
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 on progress of programs
Bachelor’s level degree required.

Nice To Haves

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

Responsibilities

Leads local execution team for assigned programs consistent with country level ways of working
Utilize available technology proficiently to manage local study delivery and identify opportunity for operational optimization
Directing country execution team to achieve quality and timeliness of all study deliverables (site identification, feasibility, start up, recruitment, data deliverables).
Ensuring resource optimization of assigned team to deliver to committed clinical program targets.
Development and performance management of direct reports and ensuring 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
Participate 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.
Contributing to transformation initiatives, shaping processes to standardize ways of working country level, and manages change to ensure contribution to effective COM organization
Accountable for monitoring metrics and Key Performance Indicators (KPIs) across all studies
Ensuring 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) to raise and resolve study specific blockers quickly
Partnering 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.
Overseeing local team member interactions with IRB/Ethics Committees
Approving site selections for each study
Ensure timely completeness a of the eTMF
Ensuring that a post-trial access plan is in place as part of study completion
Compliance of local study team and contract workers (including FSP) with Alexion SOPs
Proactively connecting with other Country leaders to share issues and learnings to ensure overall success of COM organization
Managing internal and external stakeholders, and supporting 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
Developing expertise in analyzing and resolving issues relating to study execution and compliance in fast evolving clinical trial landscape
Ensuring that respective execution teams are appropriately qualified and trained for the roles they undertake
Driving continuous improvement and team performance monitored via global, regional and country performance metrics ensuring high quality delivery
Identifying performance issues and/or areas of opportunity for continuous improvement