Clinical Trial Manager

vor 3 Monaten

Melbourne, Österreich Precision Medicine Group, Llc. Vollzeit

Clinical Trial Manager (Australia) - Clinical Trial ServicesLocation: Remote AustraliaJob Type: Regular Full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4734
We have a current opportunity for an experienced Clinical Trial Manager in Australia
Join our growing team.
Precision for Medicine is a precision medicine CRO.
Precision's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and a passion for rare diseases and oncology, in addition to working across other therapeutic areas.
You will be the hub of central intelligence for the studies you will be managing, leading CRAs and overseeing all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope while ensuring quality delivery.
We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details, and flourish in dynamic environments to explore this opportunity.
We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world.
If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us.
About You:You love having responsibility and a say in how clinical trials are runYou plan ahead, but have alternative options and a flexible approachYou are client-focusedYou are well-organized and able to manage timelines and shifting priorities, without sacrificing qualityYou communicate clearly, often, and concisely, knowing that your role is crucial in keeping the trial running smoothlyYou are a master at identifying any risks that threaten projects and handle them resolutelyYou thrive and work with autonomy and ownership to deliver successful outcomesThe day-to-day role, and how we will support your continued growth: Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning activities, and close-outSuccessful execution of assigned trials and ensuring completion of trial deliverablesEnsure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team membersMentoring and training of team membersIdentify challenges to study timelines/deliverables and offer creative action plans to the team/sponsorLead CRAs as they establish relationships with their sites for high-quality oversight of monitoring, regulatory, IP, site payment, and overall site correspondence activitiesMaintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfactionQualificationsBachelor's degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncologyOther Required:
Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO/Pharma or Biotech company (in a dedicated 'clinical lead' role)Working knowledge of GCP/ICH guidelines and the clinical development processAvailability for domestic and international travel including overnight staysSkills:
Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)Demonstrated ability to develop positive working relationships with internal and external organizationsDemonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development planDemonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implementPrecision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power.
We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments.
We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials.
Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway.
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