Global Study Associate , Waltham, MA or Gaithersburg, MD
Are you ready to join our Early Oncology Study Management Team at AstraZeneca and make a difference for patients living with cancer?
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 passionate about the potential of science to address the unmet needs of patients around the world. We commit to those areas where we believe we can really bring big new ideas to life and change the course of medicine.
AstraZeneca's vision in Oncology is to push the boundaries of science to change the practice of medicine, transform the lives of patients living with cancer, and to ultimately eliminate cancer as a cause of death. Our broad pipeline of next-generation oncology medicines has nearly 100 clinical trials ongoing and a robust pipeline of preclinical therapies!
Come and join our AZ team where you will play a pivotal role in this exciting period of development.
The Early Oncology Clinical Programs & Study Operations group are accountable for delivering high quality, cost efficient early phase clinical studies (phase 1 to phase 2b) that support drug development within Oncology.
We are looking to recruit experienced Global Study Associates to join our Early Oncology Clinical group. 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.
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.
Required Experience, Skills, and Qualifications
Have a university degree / Bachelor's degree or equivalent experience
Possess a basic understanding of the drug development process as well as a basic knowledge of ICH-GCP principles
Minimum of 1-2 years' experience of administrative / operational support of clinical studies
Demonstrate the following behaviors;
Ability to coordinate and prioritize multiple tasks and deliverables
Proactive approach, high degree of flexibility, demonstrated verbal and written communication skills
Making a difference every day by delivering life-changing medicines to millions of people globally, our purpose is ambitious and so is our approach. Becoming a more agile and creative company means building a culture that inspires innovation and collaboration. If this sounds like the place for you - don't hesitate to apply and Join us to become part of a Great Place to Work!!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender 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. These roles will be in our 2 major R&D hubs and not remote.
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. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization 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.