Clinical Trial Manager I
Clinical Trial Manager I
This is what you will do:
Supports the CPLs and CTMs for business administrative tasks, especially for trial master file creation, maintenance, closure, and transfer for a single product and multiple studies per company or CRO SOPs. Handles centralized business process tasks, e.g., CDA generation, submission of insurance documentation, safety letter tracking, CSR appendix generation, patient safety cards procurement to support the study.
You will be responsible for:
- Create, maintain, index and scan documents/files for all site related paper or electronic documents required in the TMF.
- Assists with ongoing review of the TMF and checks document compliance for active and archived projects.
- Ensure that project documents are maintained per relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs).
- User of systems and business technologies to document and track study and user progress.
- Serve as a content manager for study-specific SharePoint sites
- Procure, print and distribute patient safety cards in multiple languages for use across studies.
- Serve as CIOMS coordinator to track and update log of investigator letters against Investigator Brochure.
- Manage all Safety Reports in TMF and Investigator portal systems, including: QC, distribution and tracking.
- Coordinate delivery of documents to support registration of a protocol in ClinTrials.gov/EUdract and monitor its update throughout a study.
- Act as central point of contact for vendor providing this service.
- Enter, track and route contracts for legal input and approval using business systems and SharePoint.
- Submit ereqs in the system for approval.
- Provide administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required.
- Secure documents from the TMF that will be used in CSR appendices for CSR at study close-out.
- Upon site closure, prepares subject files, inventories documents, reconciles document discrepancies, and organizes study files for electronic archive and off-site storage.
- May attend cross functional meetings for initiatives in conjunction with the CoE.
You will need to have:
- 2-year clinical research experience or course-work equivalent in clinical research.
- Strong verbal, written, and organizational skills with a team-oriented approach.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
- Proficiency in Microsoft Office Suite and email.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Bachelor’s degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development is desirable.
- Experience working in clinical research / medical environment, including exposure to medical or regulatory records highly desired.
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 authorisation and employment eligibility verification requirements.