Clinical Project Assistant

Job Description1. To provide general administrative support to the Clinical Operations Department and assistance to Clinical Project Manager(s) and Therapeutic Area Head(s).2. To assists clinical study team (CST) with selective aspects of trial management from start-up to close Role & Responsibilities3. Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.4. Provides support in creating the Trial Master File (TMF/eTMF); with oversight, assists with maintenance tasks such as tracking and filing for the duration of the study, and with preparation for audits/ inspections and archiving.5. Co-ordination for set-up, access requests, and maintenance for project systems (e.g. eTMF, EDC, Shared Drive). 6. To assist with maintaining and updating trial related data in an existing database, (e.g. eTMF) which may require contacting internal team members to gather information.7. Generates and formats study-related data in reports and compiles data as requested.8. Supports with the preparation and distribution of study-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets and presentations).9. Facilitates in the receipt, collection, tracking and review of trial related documents.10. Facilitates with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings etc).11. To process data collection forms (i.e. log in, tracking, quality control) as appropriate for the study.12. Responsible for maintaining of clinical study team lists.13. Supports with completion of relevant clinical study team training tracking.14. Provide other study support to functional teams as directed by Line Management.15. Ensures all required training is completed and documented.16. Review of trial documents for accuracy and completeness before placing in TMF/ eTMF.17. Review of invoices received for the study and track / monitor the trial budget for each vendors for the assigned study

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