Clinical Project Manager

About the company

A local Australian sponsor managing the clinical trials for a leading pharmaceutical company based overseas focusing on research, development, manufacturing and commercialisation of innovative and high-quality healthcare products.

About the opportunity

The Clinical Project Manager will oversee and manage CROs to ensure the deliverables are met in accordance with Good Clinical Practice guidelines (GCP) and appropriate local regulations.

Responsibilities

• Lead planning and communication with cross-functional teams to ensure proper execution and conduct of the trial
• Serve as Sponsor local primary contact for CRO and vendor personnel
• Provide oversight and management of CROs and vendors during the conduct of the clinical trials to achieve high quality of the study within the timeline
• Track and report on the progress of assigned clinical trials including issues resolving, milestone, budget and timelines
• In coordination with the internal line functions and CRO, ensure effective project plans are in place and operational for each trial
• Provide study updates to internal line functions and management team
• Perform oversight and review of study related documents prepared by CROs and Vendors
• Track and assess CRO's performance according to the contract and study associated documents and plans
• Assist in central lab and IP management for each trial
• Organize (or assists with organizing) and participates in meetings - i.e. Study Team Meetings, Investigator Meetings, and CRO Training, etc
• Review and approve invoices in collaboration with the CRO to ensure investigator payments occur in a timely manner
• Engage and liaise with local investigators as the representative of local Sponsor
• Provide support and mentorship to Clinical Project Assistant
• Perform site visit /travel as needed

Skills and Experience

• Minimum University degree and / or equivalent, preferred in biological science or healthcare-related field.
• Minimum 3 years experience in Clinical Operations or other related fields
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.

How to Apply

Click apply or contact Christine Bristol, Executive Consultant on 02 8877 8766 for a confidential discussion.