Local Study Manager
Wilmington, DE
| Employer: | AstraZeneca |
| Job Type: | Full Time |
Description | |
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Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study start-up through study close-out activities and Clinical Study Report (CSR). Work with US local study team, with internal and external partners, on local studies across different phases of drug development and different therapy areas. What you will do Coordinate operational aspects of AZ Sponsored studies from Study start-up through CSR/Publication. • Lead and/or participate in activities that ensure quality, consistency and integration of study data to agreed time, cost and quality objectives • Interface with field monitoring CRAs, Local Study Associate Director (LSAD) and global study team (GST) • Establish and maintain interactions with key stakeholders including the facilitation of communications with GST, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget and quality objectives • Implement globally agreed Development Operations strategies including processes and use of technical systems related to Operations • Contribute to the development of Operations documents as appropriate as well as any updates/amendments to those documents • Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools (e.g., VCV) • Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate • Contribute to the planning and conduct of any local internal and external meetings (e.g. Investigator/Monitors meeting) • Monitor study conduct and progress, proactively identifying and resolving with the LSAD issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives • Contribute to steering committees, submission assembly teams, regulatory defense teams, and Advisory Boards as necessary Educational and Experience Requirements
• Experience working on clinical studies, across different phases of drug development • Relevant industry or health care experience • Proven organizational and analytical skills • Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities • Computer proficiency • Excellent knowledge of spoken and written English • Demonstrates ability and willingness to work and lead cross-functionally, e.g., with internal and external partners, on global studies, across different phases of drug development or different therapy areas • Good understanding of clinical data flow • The ability to develop advanced computer skills to increase efficiency in day to day tasks • Demonstrated Project Management skills (e.g. leading delivery team) • Excellent mentoring skills and ability to develop others
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