Primary accountability:

• Quality and timeliness of study deliverables (site identification, feasibility, start up, recruitment, data deliverables, filing of complete study documentation) for assigned study(ies)
• Proactive reporting of study-specific issues (including monitoring metrics) to the study team via the Study Lead Country Operations (SLCO)
• Quality of 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
• Oversight of FSP and /or contingent workers on assigned study(ies)
• Review if local regulatory documentation and oversight of local regulatory activities
• Relationship management with the national coordinating investigator as applicable

Primary responsibility:

• 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)
• Conduct trainingof CRAs
• Review Clinical Monitoring Documentation
• Inspection readiness activities
• Relationship management with sites
• Provide feedback to Internal and External Stakeholders as appropriate
• Develop and maintain tracking tools
• Drives quality efforts to proactively identify and manage risks to study quality

Qualifications

• Proven experience in the oversight and delivery of operational aspects of all stages of 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 is expected
• Proven experience in effectively communicating with site staff including and including KOLs and thought leaders
• Comprehensive and current regulatory knowledge, including GCP
• Experience conducting GCP or other training is a plus
• 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
• Proficient with MS Office Suite (Excel, Word and PowerPoint).

Preferred Qualifications

• 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 relevant experience gained with a CRO or pharmaceutical company working on multinational clinical studies; Lead CRA/management experience preferred
• Proven experience in managing high priority / complex studies through phases 1 – 4 and in rare medical conditions preferred
• Previous oversight and regulatory inspection experience preferred

Date Posted

Closing Date

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 accommodations@Alexion.com. Alexion participates in E-Verify.