Description:
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
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- Acting as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits
- Reviewing quality metrics and provide solutions for continuous improvement
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- 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