Global Study Associate, Oncology R&D, Early Oncology Clinical

Location: Hybrid (Gaithersburg, MD or Waltham MA). This is NOT a fully remote position Summary: The Global Study Associate is responsible for supporting the delivery of clinical studies by providing administrative and system support. The Global Study Associate will work across several studies, so a high degree of flexibility is required. The exact accountabilities will differ depending on the exact nature of the clinical program. Responsibilities: Collect, review and track relevant study documents. Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF). Coordinate regular Quality Checks (QC) and review of the TMF, ensuring continual inspection readiness. Support production of study documents, ensuring template and version compliance and that relevant documents are ready for publishing in the regulatory document management system. Set-up, populate and accurately maintain information in tracking systems and communication tools. Support other study team members in the use of these systems. Manage and contribute to the coordination and tracking of study materials and equipment. Assist in the tracking and reconciliation of invoices. Support study team and provide study metrics / reports during the study, audits and regulatory inspections. Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, investigator meetings and advisory boards. Liaise with internal and external participants and/or vendors. Track approvals and completion of required documents. Prepare and distribute study-related correspondence. Contribute to and distribute material for meetings, newsletters and websites. Requirement: Bachelor's Degree and 1 years of experience, Associate's degree plus 6 years of experience or High School plus 10 years of experience Knowledge of ICH-GCP principles Team orientated Ability to coordinate and prioritize multiple tasks and deliverables Proactive approach High degree of flexibility Demonstrated verbal and written communication skills Date Posted 13-Oct-2023 Closing Date 19-Oct-2023 When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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. AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law. AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process. You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.