ACCOUNTABILITIES

• Quality and timeliness of study deliverables: site identification, feasibility, start-up, recruitment, data deliverables, filing of complete study documentation, and site closures for assigned studies.
• Conduct country feasibility assessments with local affiliate functions and global collaborators.
• Ensure site selection process is conducted by identifying potential sites/investigators and performing Site Quality Risk Assessments.
• Timely submission of application/documents to evaluating authorities in line with local regulations.
• Collaborate on negotiation of site study contracts and budgets at country level.
• Drive compliance with committed site activation and patient enrolment projections.
• Set up and maintain study in CTMS at country level as required by local laws and regulations.
• Manage monitoring activities from site activation through to study closure.
• Meet recruitment targets for assigned studies and drive Country/site recruitment action plans.
• Proactively report study-specific issues to the study team.
• Reporting to HCO and LM regarding local study team performance and providing regular updates on study achievements/key risks.
• Lead risk-based quality meetings and project performance reviews for assigned studies.
• Manage relationships with national key opinion leaders and external collaborators impacting the country’s rare disease strategy.

ESSENTIAL SKILLS/EXPERIENCE

• Bachelor’s Degree or equivalent in clinical practice/health care, life sciences or drug development required; clinical or advanced degree preferred.
• Relevant experience with a CRO or pharmaceutical company managing multinational clinical studies
• Proven ability for successful delivery of phase 2 - 3 internal clinical trials within budget, timelines, and enrolment metrics.
• Strong proven project management skills.
• Experience working collaboratively with medical affairs across a broad portfolio.
• Demonstrated capability in working with various teams to manage project achievements and recruitment goals.
• Strong leadership skills: decision-making, mentoring, coaching, troubleshooting, influencing quality and delivery.
• Strong communication skills: establish trustworthy relationships with collaborators; acknowledged as dependable support by the global study team.
• Proven ability to communicate complex scientific, medical, and organisational concepts internally and externally.
• Initiates ongoing efforts to review standard methodologies within study teams.
• Good independent management of tense situations; effective communication with site staff including KOLs.
• Excellent organizational skills: independently plan/manage projects including budget management.
• Ability to work cross-functionally; timely risk identification and mitigation plan development.
• Solid knowledge of clinical development processes; track record of ensuring GCP compliance and risk management.
• Advocate for what we value.
• Flexibility in schedule; willingness to travel up to 20% during busy periods.
• Proficient with MS Office Suite (Excel, Word, PowerPoint).
• Excellent knowledge of spoken/written English.

DESIRABLE SKILLS/EXPERIENCE

• Proven experience managing high priority/complex studies through phases 1 – 4 in rare medical conditions preferred.
• Previous oversight and regulatory inspection experience preferred.
• Excellent understanding of the end-to-end Clinical Study Process including monitoring.
  When we put experienced individuals 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 foster a culture where diversity is valued and inclusion is championed. Our commitment to innovation drives us to explore new ideas that profoundly impact patients’ lives. We celebrate achievements and reward each other while maintaining kindness as a core value. Our dedication to giving back to communities ensures that our work is meaningful beyond the workplace.
  Ready to make a difference? Apply now to join our team!

Please refer the Job description for details