Director Country Operations Management
Director Country Operations Management
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Job Description
The Director Country Operations Management (DCOM) will lead a local team fully accountable for all study deliverables and quality for programs in their country for their aligned Therapy Areas (TA). The DCOM is accountable for 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 costeffective 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 startup enrollment data deliverables and closeout 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 Project Managers Country Operations (PMCO) and Clinical Study Assistants (CSA) and is responsible for planning and optimization of reporting resources including objective setting performance followup and contributes to shaping processes to standardize ways of working country level and managing change.
For their assigned TA 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).
You will be responsible for:
Leads local team for programs in aligned TA(s) consistent with country level ways of working
Utilize available technology proficiently to manage local study delivery and identify opportunity for operational optimization
Directing country team to achieve quality and timeliness of all study deliverables (site identification feasibility start up recruitment data deliverables) for aligned TA.
Ensuring resource optimization of assigned team to deliver to committed clinical program targets for aligned TAs
Development and performance management of direct reports and ensuring each direct report has development and training plans according to company policy and people plans. Handson 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 in aligned TAs
Ensuring crossfunctional 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 Startup 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 TA team member interactions with IRB/Ethics Committees
Approving site selections for each study for aligned TA
Ensure timely completeness a of the eTMF
Ensuring that a posttrial 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 TAlevel 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 TA and local study level; escalates to SD HCO appropriately
Developing expertise in analyzing and resolving issues relating to study and compliance in fast evolving clinical trial landscape
Ensuring that respective 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
Qualifications:
Bachelors level degree required plus 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 crossfunctional 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. Welldeveloped problem solving organizational and negotiating skills.
Available for domestic and international travel up to 25 dependent on progress of programs
Preferred Qualifications:
Previous field CRA experience
Experience running clinical studies for ultrarare diseases and capability to develop and implement innovative solutions for optimizing the conduct of ultrarare 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
Date Posted
14Feb2025Closing Date
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.Required Experience:
Director
Employment Type
Full-Time
