Position SummaryThe Study Lead Country Operations (SLCO) is the primary point of contact for the Country Operations (CO) team at the global study level and will act as a core study team member. The SLCO will be accountable for coordinating and driving activities performed by country operations including start up, monitoring, site oversight, quality and specific study deliverables. The SLCO will, therefore, be involved in study documentation review, coordinating CO activities globally, and will act as a liaison for other key stakeholders for relevant site and monitoring issues at country level.
The SLCO be responsible for liaising with Country Operations personnel to conduct the feasibility process, providing feedto the study team regarding potential site and patient numbers.
The SLCO is responsible for utilizing and interpreting data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
The SLCO may be required to visit sites with the CRAs (CRO, FSP or in-house as applicable), or with other Alexion personnel (e.g. CO, Global Medical Affairs, etc.) for Sponsor Oversight, Inspection Readiness or Engagement Visits.
Job Accountabilities & ResponsibilitiesAccountable for
- Monitoring and site oversight globally assigned study(ies), representing the monitoring function on the Global Study Team
- Aggregation and communication of deliverables for assigned study(ies), globally, to the Clinical Program Lead (CPL)
- Resourcing and training of Functional Service Provider (FSP) CRAs for assigned study(ies) Validating local CRO resources, as necessary, to support execution of the study(ies)
- Developing and/or reviewing applicable study documents including training materials and reports
- Delivery of appropriate protocol and indication training to Country Operations teams
- Coordinationof 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
- Liaison between Country Operations (CO) teams and the Global Study Team: act as the central point of contact for the CO team for assigned studies
- Standardization of study conduct and clinical monitoring proceses across study(ies)
- Collection of site nominations and communications thereof to the CPL
- Track trends occurring within the study that may impact other studies and communicate to the SLCO team and other key stakeholderes
- Together with the the SLCO team, standardize processes across the studies to improve efficiencies in CO activities
- Define monitoring requirements including components of Risk Based Monitoring (RBM)
- Support risk management and signal detection at a study level
- Act as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits
- Review quality metrics and provide solutions for continuous improvement
- Maintain a thorough knowledge of disease area and protocols
- Extensive clinical trial experience across a range of highly complex disease areas
- Demonstrated capability of effective CRA and site oversight
- 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.
- 8+ years of clinical research experience in biopharma or CRO
- 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
- Experience of ultra rare disease clinical research is beneficial