Clinical Trials Assistant - FSP at Parexel

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

24 Jun, 26

Salary

0.0

Posted On

26 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Management, SharePoint Online, Veeva Clinical, TMF Documentation, Regulatory Submissions, Clinical Trial Management System (CTMS), Investigational Drug Coordination, Audit Support, Meeting Administration, Regulatory Reporting, Payment Management, Investigator Database Management (IDM), Data Entry, Quality Control, Archiving Process

Industry

Pharmaceutical Manufacturing

Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Work arrangement: 2-3 times a week at the office/ 2-3 times a week working from home This role requires to come into office in Macquarie Park, Sydney. Clinical trial related general tasks as required throughout the trial life cycle ◼ Communicate internally with clinical trial team (e.g., CTM, CRA) and externally with clinical sites, vendors and other departments ◼ Set up and maintenance of trial related sharing platforms e.g., Sharepoint Online ◼ Support trial document management processes for Clinical Documentation System (Veeva Clinical, Clinergize etc) including TDS communication of document event date, document submission, quality check/resolution and set up & maintenance of paper TMF documentation/filing and arrangement of long-term archiving process if required ◼ Coordinate clinical trial related document translation process ◼ Support trial related documents verification ◼ Support trial document creation & filing process e.g., local clinical trial protocol amendment, local signature page etc. ◼ Support CTM for the site ISF archival, if locally required to use external archiving vendor ◼ Support RA/EC submission e.g., CTR relevant as applicable ◼ Support updates of clinical trial related information into Clinical Trial Management System (e.g., Veeva Clinical) ◼ Coordinate/Support investigational drug, clinical supplies, equipment preparation, maintenance e.g., calibration, and distribution/return to/from sites if applicable ◼ Support access request and maintenance for trial related systems of external vendors, if applicable ◼ Support activities for Audits, Inspections and CAPAs, if any support required ◼ Support arrangement and administrations for clinical trial related meetings e.g., Investigators meeting, if required the local OPU’s arrangement ◼ Take study team meeting minutes and subsequent distribution to relevant stakeholders ◼ Support regulatory/ethics reporting and internal tracking (e.g., Medsafe for New Zealand, CTN for Australia, Annual Ethics reporting for AU/NZ) ◼ Support trial/trial country related tracker maintenance and update ◼ Support label review process handling (for AU/NZ) ◼ OPU’s PSPV query mailbox back-up maintenance, for paper SAE reporting trials, as applicable Clinical trial system related roles and tasks as required throughout the trial life cycle ◼ Act as Payment Manager to handle trial related payment process via Veeva Clinical including Investigator fee set up, payment report generation, PO creation (if applicable) & approval, IVT approval and if required relevant communication to CRO, Sites, GBS etc., as applicable ◼ Act as (back-up) Investigator Database Manager (IDM) to manage sites/investigators/site staffs’ information update into Veeva Clinical by adhering global/local regulatory requirements (e.g., Sending Global Privacy Notice Notification mail to site staffs, Filing of Acknowledgement from site staffs, Consent status check, Maintenance of relevant local tracker (e.g., PIPA tracker) etc.), maintain investigators’ quality included in the quality report for IDM., if locally applicable General activities ◼ Coordinate organization and arrangement of CDO meetings/gathering/workshop related activities Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

This role involves supporting clinical trial documentation, including setup, maintenance, filing, and coordination of translations across the trial lifecycle. Key tasks also include acting as a Payment Manager and supporting the Investigator Database Manager within clinical trial systems like Veeva Clinical.