Country Study Manager (Alexion)

Country Study Manager

Location: Pancras Square

Competitive Salary and Benefit Package

Are you ready to make a profound impact on patients' lives? As a Country Study Manager (CSM), you will be responsible for the successful execution of study deliverables and quality execution through adherence to good clinical practices (GCP) and evolving regulatory requirements. You will ensure quality and consistency of monitoring activities, drive adherence to timelines and achievements, and identify and communicate risks to the study team. Your role will also involve the delivery of site start-up activities for assigned studies/projects, active participation in clinical study teams, and interaction with Regulatory Authorities/Ethics Committees in the UK.

Accountabilities

• Quality and timeliness of study deliverables (site identification, feasibility, start-up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies).
• Coordination and administration of start-up activities of clinical studies from site identification through site activation, including the development and management of study-specific documents.
• Proactive reporting of study-specific issues (including monitoring metrics) to the global study team.
• Oversee and conduct quality monitoring oversight in the country for assigned study(ies).
• Meeting recruitment targets for assigned study(ies).
• CDA delivery and negotiation (based on pre-approved parameters and regardless of executory party).
• Negotiation of site study budgets and contracts.
• Oversight of CRAs (FSP and/or in-house) on assigned study(ies).
• Conduct of monitoring activities at assigned sites, if required for the project as per HCO assessment.
• Review of local regulatory documentation and oversight of local regulatory activities.
• Manage the relationship with the national coordinating investigator as applicable.
• Timely and accurate responses to queries from the study team.
• Working with Medical Affairs to coordinate site feasibility and engagement activities.
• Scheduling and leading effective country calls with local study team and/or CRO.
• Resolving ICF issues in-country.
• Oversight of EC submissions and facilitate resolution of queries.
• Proposing potential investigator sites (HCO accountable for selection).
• Ensure training of CRAs for study operational requirements.
• Review Clinical Monitoring Documentation.
• Inspection readiness activities.
• Manage the relationship with sites.
• Provide feedback to Internal and External Stakeholders as appropriate.
• Develop and maintain tracking tools.
• Drive quality efforts to proactively identify and manage risks to study quality.

Essential Skills/Experience

• Bachelor's Degree or equivalent experience in one of the fields related to clinical practice/health care, life sciences or drug development is required
• Proven experience in the oversight and delivery of operational aspects of all stages of clinical trial process
• Solid knowledge of clinical development processes
• 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
• Proven experience in effectively communicating with site staff including leaders with a point of view
• Comprehensive and current regulatory knowledge, including GCP
• Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 20% during busy periods)
• Good organizational skills and ability to deal with competing priorities
• Effective communication skills (written, verbal and presentation)
• Creative thinker, curious and unafraid to ask questions
• Innovator, willing to initiate changes, introduce new ideas, and creatively problem solve
• Conduct of monitoring activities at assigned sites, if required for the project as per HCO assessment
• Employees must be able, with or without an accommodation to: travel by public transportation, automobile, train, or plane; work comfortably in a clinical setting; use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

Desirable Skills/Experience

• A clinical or advanced degree (RN, MPH, MS, MA, MBA, PharmD)
• 8+ years of relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies
• Experience conducting GCP or other training is a plus
• Previous lead CRA experience
• Proven experience in managing high priority/complex studies through phases 1 – 4 and in rare medical conditions

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we cultivate a culture that values diversity, champions inclusion, and celebrates new ideas. Our commitment to innovation drives us to create life-changing medicines that make a real difference. We believe in supporting our employees through tailored development programs that align personal growth with our mission. Join us in making an impact on patients' lives while being part of a supportive community that values integrity, diversity, and connection.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.