KE Select are proud to support and encourage the presence and success of phase I-phase III Clinical Trials within the Australian bio-ecosystem.
An opportunity exists for an experienced Clinical Trial Manager to join a successful US-based biopharmaceutical company.
About The Company KE Select has partnered with Mozart Therapeutics, a successful clinical-stage biopharmaceutical company committed to developing disease-modifying therapies that restore healthy immune system function in patients with autoimmune and inflammatory diseases.
The company, founded in 2020 and headquartered in Seattle, has a highly respected board of directors and a proven industry veteran CEO.
Mozart Therapeutics is unique in its approach to developing the treatment paradigm for patients with autoimmune and inflammatory diseases. Their objective is to reset and restore the immune system balance by leveraging a novel pathway to develop first-in-class CD8 Treg modulators as disease-modifying therapeutics to address an unmet need across a spectrum of diseases.
About The Role Based in either Melbourne or Brisbane, the Clinical Trial Manager will become part of the Clinical Operations team at Mozart Therapeutics. The role reports directly to the Director of Clinical Operations and is significantly independent within the Australian territory. However, the Clinical Trial Manager will also have the support of an Executive Board member based in Australia. You will be required to work from a home office and will be willing to work outside of standard hours at times, communicating with international colleagues. You will also be willing to travel to clinic sites when needed (travel expenses reimbursed).
The Clinical Trial Manager will serve as the Australian Clinical Operations Project Lead for clinical trials resource management and oversee the Contract Research Organization(s) and project vendors across assigned project(s). As the clinical site-facing ambassador, the Clinical Trial Manager will build impactful and sustainable relationships, supporting the clinical sites in proper delivery and removing execution barriers. This position will be a key enabler of clinical sites’ success with respect to study enrollment, site relationships, data integrity and overall quality. Responsibilities will focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety reporting. The Clinical Trial Manager will oversee 1-2 programs at various sites throughout Melbourne and Brisbane. You will have the flexibility to assume additional project assignment(s).
KEY DUTIES & RESPONSIBILITIES:
- Oversee the conduct and execution of one or more assigned clinical trials and associated activities in compliance with GCP and relevant national and international regulations.
- Assist in reviewing and selecting suitable investigational sites and vendors to ensure optimal study performance.
- Coordinate and manage various tasks in collaboration with other sponsor roles to prepare and maintain essential study documents, including manuals, forms, and plans.
- Collaborate with cross-functional teams to review study-related documents, including protocols, case report forms, and informed consent forms.
- Participate actively in cross-functional study team meetings to ensure project goal and timeline alignment.
- Ensure adherence to GCP and global regulatory guidelines throughout the lifecycle of clinical trials.
- Assist in identifying and managing protocol deviations and risks.
- Collaborate with Contract Research Organizations (CRO) and sponsor team members to ensure data integrity and timely data entry including timely resolution of queries in the Electronic Data Capture (EDC) systems.
- Perform periodic reviews of the CRO electronic Trial Master File (eTMF) to confirm compliance with standards and regulations.
- Support audit and inspection activities as needed, ensuring readiness and compliance.
- Liaise with clinical site personnel to address study-related needs and concerns effectively.
- Liaise with US personnel, including Clinical Operations, CMC, and Clinical leadership.
- Oversee and/or perform external data reconciliation against clinical databases to ensure accuracy, including laboratory sample reconciliation.
- Manage timelines and expectations for external data reconciliation and deliverables.
- Compile and review data listings for both ad hoc and scheduled reviews to meet the sponsor's needs.
- May help manage additional supplies in the country if necessary.
About You EDUCATION AND EXPERIENCE:
- Minimum of 5 years of clinical trial experience including clinical trial management, in pharmaceutical, biotech or CRO setting
- Experience in Phase I-III clinical trials. Global experience preferred.
- A bachelor’s degree (or equivalent) in a relevant scientific field is preferred.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Thorough knowledge of drug development, clinical operations processes, and procedures according to FDA GCP/ICH regulatory guidelines.
- Proficiency with MS Office products Word, Excel, SharePoint, and PowerPoint.
- Expertise in clinical trial management systems, specifically Veeva, and electronic data capture (EDC) platforms, such as Medidata.
- Able to recognise need(s), find solutions, and take the initiative to address them proactively.
- Strong organizational and time management skills.
- Excellent communication skills, both oral and written.
- Strong team player with a demonstrated track record of success in a cross-functional team and fast-moving environment.
- Proven ability to effectively collaborate with internal teams and external collaborators
