Associate Director Clinical Lead

The Study Lead Country Operations (SLCO) is the primary point of contact for the Country Operations Management (COM) team at the global study level, partnering closely with the Clinical Project Lead (CPL) and other global functional stakeholders as required. The SLCO is the global representative for COM, acting as the conduit between the in-country COM teams and the global team.

The SLCO is accountable for coordinating and facilitating activities performed by the in-country COM teams that relate to site management and monitoring. The SLCO supports and drives tasks performed across the COM team globally for the assigned study, including:

• Work with global and country teams to determine appropriate country footprint for the study, including consolidation of information from country teams to support internal governance approvals for the study
• Lead Key External Expert (KEE) outreach activities, working with the sponsor Global Feasibility & Site Intelligence (GFSI), and across COM to assess study design suitability or identify opportunities for protocol improvement
• Work with GFSI on detailed site feasibility and coordinate with country teams to arrive at proposed final breakdown of countries/sites/patients for endorsement by Global Program Team (GPT)
• Coordinate and maintain global oversight of country and site start-up (SSU) activities performed by country teams and/or CRO partner
• Contributes to patient recruitment, retention and engagement strategy development and execution (inclusive of patient insight activity)
• Maintain global oversight of study deliverables, milestones and site monitoring (e.g., country/site selections, startup activities, enrolment, data metrics, close-out activities, etc.) throughout the study lifecycle
• Ensure a state of ‘Inspection Readiness’ 
• Work with global and country-level stakeholders to mitigate risks or issues related to site management and monitoring as they arise

You will be responsible for:

• Coordination of start-up and recruitment activities at the study level, across all countries
• Monitoring and site oversight globally on assigned study(ies), representing the monitoring function on the Global Study Team
• Aggregation and communication of deliverables for assigned study(ies), globally, to the global Clinical Trial Team (CTT) and country teams respectively
• Resourcing (with assistance of country teams) and training of CRAs for assigned study(ies)
• Developing and/or reviewing applicable study documents including, but not limited to, training materials, clinical monitoring and oversight plans
• Delivery of appropriate protocol and indication training to country teams
• Overseeing relevant study milestone management, study tracking and other assigned study tasks
• Coordinating country teams activities related to key study events, such as protocol amendments, interim database locks and Investigator Meetings
• Ensuring deployment of inspection readiness measures: including preparation of storyboard tools and required documentation
• Post final database lock, overseeing country activities related to site close out activities and post-trial access, as required
• Supporting the end-to-end feasibility process, including communications of country and site recommendations to the CTT and other stakeholders
• Acting as a liaison between country teams and the global CTT: act as the central point of contact for COM for assigned studies
• Supporting escalation of resourcing or vendor needs, as necessary, to support execution of the study(ies)
• Defining monitoring requirements including components of Risk Based Quality Monitoring (RBQM)
• Supporting risk management and signal detection at a study level, including appropriate communication to the SLCO team and other key stakeholders
• Together with the SLCO team, imputing into ongoing process initiatives across studies to improve efficiencies in COM activities
• Acting as a Subject Matter Expert for Sponsor Inspections by Regulatory Agencies or during audits
• Reviewing quality metrics and providing solutions for continuous improvement

Requirement:

• Masters or Doctoral degree or equivalent in a scientific or business discipline preferred.
• 8+ years of clinical research experience in biopharma or CRO
• Experience of managing multiple studies including extensive experience in the management and oversight of CROs
• Experience of ultra-rare disease clinical research is beneficial
• Ability to travel
• Local language required