Job Description

This is what you will do:

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 Alexion 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 \xe2\x80\x98Inspection Readiness\xe2\x80\x99
• 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:

Accountable 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

Responsible For:

• 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
• Maintaining a thorough knowledge of disease area and protocols

You will need to have:

• Bachelor\xe2\x80\x99s level degree required.
• Demonstrated project leadership and strong communication 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
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• 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

#LI-Hybrid

Date Posted 18-Jul-2023

Closing Date 17-Sep-2023

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

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