If you’re inspired by the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Clinical Trial Management System (CTMS) AnalystI in Gaithersburg, MD, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and Responsibilities
As CTMS Analyst I, you will provide clinical study teams and IS/IT with central business support of the Clinical Trial Management System (CTMS), data analytics and the Clinical Dashboard to ensure a high level of compliance and data quality for Clinical Biologics. Additionally, you will review and update all study site contact information in CTMS as requested, support study site creation and key trial updates in the CTMS system as needed, and provide regular CTMS status information to CTMS support team members and CTMS users.
Additional duties and responsibilities will include the following: Assist as requested the study team in review of data for study setup in CTMS; Assist with CTMS set-up for trial tracking and clinical site monitoring; Maintain CTMS reference data information; Initiate and facilitate creation and maintenance of CTMS user accounts; Review and address CTMS site level data compliance issues; Generate, maintain, and distribute standard CTMS reports for performance excellence and data quality; Assist with training needs as requested; Complete full review of business process steps in support of CTMS and review/ update as necessary; Provide recommendations on best use of CTMS to support study management; Assess Business As Usual processes and investigating improvements to processes.
- BS/BA or equivalent experience
- Computer literate and proficient in Microsoft Office, Business Objects and SharePoint.
- Experience in using or supporting CTMS or other clinical systems.
- A working knowledge of ICH GCP and relevant regulatory requirements.
- Able to build positive relationships with CTMS users, peers, and management.
- Detailed oriented and can follow through to get issues properly addressed or resolved.
- Customer service attitude.
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