Director, Study Lead, Country Operations



Managing a global team of therapeutically aligned Study Leads Country Operations (SLCOs) to support the delivery of programs, based on organizational needs

  • Developing appropriately qualified and trained direct reports for their respective roles
  • Staff management, people development, succession planning and team leadership
  • Appropriate application of monitoring and site oversight strategies for Alexion studies
  • With HSLCO, providing oversight of key study milestones and recruitment progress globally to drive delivery of high quality trials across the portfolio
  • Tracking and trending of monitoring metrics and related Key Performance Indicators (KPIs) across studies
  • Acting as a point of escalation for internal and external senior level stakeholders for global issues related to study monitoring and site oversight
  • Input into functional area budgets and resource forecasting, reporting necessary updates to the HSLCO
  • Contributing to the design and maintenance of processes and systems to enable cost and time effective execution of high-quality clinical studies in accordance with applicable reguluations
  • Implementation of clinical infrastructure including SOPs, policies and cross-functional communication and interaction
  • Supporting HSLCO to deliver a consistent operational approach across Alexion clinical studies
  • Where DSLCO has study responsibility:
  • Acting as a point of escalation for internal and external senior level stakeholders for global issues related to study monitoring and oversight on Alexion studies
  • Monitoring and site oversight globally for assigned study(ies), representing COM on the Clinical Trial Team
  • Aggregation and communication of deliverables for assigned study(ies), globally, to the Clinical Project Lead (CPL)
  • Validating local CRO resources, as necessary, to support execution of the study(ies)
  • Developing and/or reviewing applicable study documents and training materials
  • Facilitating appropriate protocol and indication training of COM/ CRAs for assigned study(ies)
  • Coordination of start up and recruitment activities at the study level, across all countries
  • Ensuring deployment of inspection readiness measures: including preparation of tools and required documentation

Responsible For

  • Managing SLCOs, including supporting the development of objectives and allocation of resource across studies
  • Providing guidance to SLCOs in analyzing and resolving issues relating to study execution and compliance
  • Leading, motivating, setting objectives and managing performance of assigned SLCOs to ensure completion of goals
  • Developing staff to improve individual performance and that of the team as a whole
  • Partnering with appropriate internal stakeholders, including quality and compliance ,data management and Operational Excellence groups to ensure compliance and inspection readiness
  • Supporting the standardization of study conduct and clinical monitoring proceses across study(ies)
  • Defining monitoring requirements including components of Risk Based Monitoring (RBM)
  • Interacting with Regulatory Authorities when appropriate; adhering to regulatory requirements whilst maintaining compliance and delivering against company objectives
  • Building and maintaining effective relationship across internal stakeholder groups
  • Where DSLCO has study responsibility:
    • Acting as a liaison between COM and the Clinical Trial Team, acting as the central point of contact for the COM team for assigned studies
    • Collection of site nominations and communications thereof to the CPL
    • Tracking trends occurring within the study that may impact other studies and communicating to the SLCO team and other key stakeholderes
    • Supporting risk management and signal detection at a study level
    • Acting as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits
    • Reviewing quality metrics and provide solutions for continuous improvement
    • Maintaining a thorough knowledge of disease area and protocols

You Will Need To Have

  • Ten plus years of clinical research experience with experience in the development & management of a clinical operations function and staff management in a pharmaceutical and/or biotechnology environment
  • Proven excellence in operational strategy, project management and delivery of global clinical operations activities across multiple projects in highly complex disease areas
  • Demonstrated ability to build, coach, mentor, motivate and supervise a high performing teams
  • Thorough knowledge of global regulatory requirements and ICH/GCP guidelines
  • 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 interpersonal skills across countries, cultures and organizational functions
  • Well developed problem solving, organizational, and negotiating skills
  • Solid knowledge of clinical development processes with strong emphasis on monitoring
  • Track record of establishing effective relationships with investigator sites
  • Ability to lead, troubleshoot and influence for quality and delivery
  • A track record of ensuring GCP compliance and successful risk management of complex clinical studies is expected
  • Ability to travel as required internationally and domestically. Demonstrates flexibility in schedule and willingness to travel up to 25%.
  • Bachelor's Degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences or drug development is required. A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD) is preferred.

We Would Prefer For You To Have

  • 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
  • Demonstrated capability of effective CRA and site oversight
  • Previous line management experience
  • Demonstrated project management skills across multiple highly complex clinical studies
  • Experience of managing multiple studies including extensive experience in the management and oversight of CROs

Organization Alexion Pharmaceuticals, Inc
Industry Operations Jobs
Occupational Category Director
Job Location London,UK
Shift Type Morning
Job Type Full Time
Gender No Preference
Career Level Department Head
Experience 10 Years
Posted at 2022-01-11 2:09 am
Expires on 2022-06-22