Location:Wilmington, Delaware, United StatesJob reference:
Jan. 19, 2017
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, in Wilmington, DE, 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 Requirements and Preferred Background
- Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
- Minimum 3 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.