Associate Director, Study Lead Country Operations

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 as Sponsor Dedicated with a Key Pharmaceutical Company, 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 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 oversight of study deliverables and site monitoring throughout 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

**Principal Responsibilities**
- Coordination of star
- 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)
- 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
- Ensuring deployment of inspection readiness measures: including preparation of storyboard tools and required documentation
- Supports the end-to-end feasibility process, including communications of country and site recommendations to the CTT and other stakeholders
- Liaison between country teams and the global CTT: act as the central point of contact for COM for assigned studies
- Support escalation of resourcing or vendor needs, as necessary, to support execution of the study(ies)
- Define monitoring requirements including components of Risk Based Quality Monitoring (RBQM)
- Support 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, input into ongoing process improvement initiatives across studies to improve efficiencies in COM activities
- 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

**Qualifications**:

- Demonstrated project leadership skills
- Extensive clinical trial experience across a range of complex disease areas
- Demonstrated capability of effective monitoring oversight
- Ability to operate effectively in a highly matrixed team environment
- Ability to work autonomously and within a team structure and able to demonstrate initiative
- 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
- Demonstrates flexibility in schedule and ability to travel as required internationally and domestically
- 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

Education
- Bachelor’s level degree required. Masters or Doctoral degree or equivalent in a scientific or business discipline preferred

What we offer
- Focus on quality, not quantity We invest in keeping our teams stable, so workload is consistent.
- The chance to work on cutting edge medicines right at the forefront of drug deve