At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Local Study Leader, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
In this position, your main responsibility will be to lead the Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
In addition to leading LST(s), you will be expected to perform site monitoring if needed. As part of the flexible capacity model it is expected that this position manages both roles. You will be held responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
• Assist Line Managers (SMM Director/CRM) in efficient functioning of the department at country level.
• Prepare and maintain study budget at country level in ACCORD.
• Liaise with Local Compliance Officer regarding payments to Investigators to ensure these are in accordance with local requirements.
• Timely preparation and support to process of registration of applicable clinical studies in country-specific or regional websites.
• Ensure that clinical and operational feasibility assessment of Study Design Concept and Clinical Study Protocol is performed to highest quality.
• Keep track on research intelligence in local markets.
• Support SMM region in initiatives/activities as agreed with Line Manager (SMM Director/CRM).
• Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
• Minimum 2 years of experience in Clinical Operations or other related fields (Medical Affairs-led studies or Academic-led studies)
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law . AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.