Clinical Trial Manager
vor 7 Stunden
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KE Select is 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 clinical-stage biopharmaceutical company committed to developing disease-modifying therapies that restore healthy immune system function in patients with autoimmune and inflammatory diseases.
Founded in 2020 and headquartered in Seattle, the company has a highly respected board of directors and a proven industry veteran CEO.
Mozart Therapeutics is unique in its approach to developing therapies for patients with autoimmune and inflammatory diseases.
Their objective is to reset and restore immune system balance by leveraging a novel pathway to develop first-in-class CD8 Treg modulators as disease-modifying therapeutics.
About The Role Based in either Melbourne or Brisbane, the Clinical Trial Manager will be part of the Clinical Operations team at Mozart Therapeutics.
The role reports directly to the Director of Clinical Operations and operates independently within the Australian territory, with support from an Executive Board member based in Australia.
The position requires working from a home office, willingness to work outside standard hours, and travel to clinic sites as 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 projects.
As the clinical site-facing ambassador, the Clinical Trial Manager will build impactful relationships, supporting clinical sites in delivery and removing execution barriers.
Responsibilities will focus on investigators, 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, with flexibility to assume additional project assignments.
KEY DUTIES & RESPONSIBILITIES: Oversee the conduct and execution of assigned clinical trials in compliance with GCP and relevant regulations.Assist in reviewing and selecting suitable investigational sites and vendors.Coordinate and manage tasks to prepare and maintain essential study documents.Collaborate with cross-functional teams to review study-related documents.Participate in cross-functional study team meetings to ensure project alignment.Ensure adherence to GCP and global regulatory guidelines throughout clinical trials.Assist in identifying and managing protocol deviations and risks.Collaborate with CROs to ensure data integrity and timely data entry.Perform periodic reviews of the CRO electronic Trial Master File.Support audit and inspection activities as needed.Liaise with clinical site personnel to address study-related needs.Liaise with US personnel, including Clinical Operations and Clinical leadership.Oversee and/or perform external data reconciliation against clinical databases.Manage timelines and expectations for external data reconciliation.Compile and review data listings for both ad hoc and scheduled reviews.May help manage additional supplies in the country if necessary.About You EDUCATION AND EXPERIENCE: Minimum of 5 years of clinical trial experience 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 and clinical operations processes according to FDA GCP/ICH guidelines.Proficiency with MS Office products and clinical trial management systems.Strong organizational and time management skills.Excellent communication skills, both oral and written.Strong team player with a proven track record in a cross-functional team environment.Ability to effectively collaborate with internal teams and external collaborators. #J-18808-Ljbffr
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Clinical Trial Manager
vor 6 Stunden
Brisbane, Österreich Ke Select VollzeitAdd expected salary to your profile for insights.KE Select is 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 CompanyKE Select has partnered with...
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