Clinical Trial Manager
vor 1 Monat
Clinical Trial Manager (Australia) - Clinical Trial Services Location: Remote Australia Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition 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 run You plan ahead, but have alternative options and a flexible approach You are client-focused You are well-organized and able to manage timelines and shifting priorities, without sacrificing quality You communicate clearly, often, and concisely, knowing that your role is crucial in keeping the trial running smoothly You are a master at identifying any risks that threaten projects and handle them resolutely You thrive and work with autonomy and ownership to deliver successful outcomes The 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-out Successful execution of assigned trials and ensuring completion of trial deliverables Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members Mentoring and training of team members Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor Lead CRAs as they establish relationships with their sites for high-quality oversight of monitoring, regulatory, IP, site payment, and overall site correspondence activities Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction Qualifications Bachelor's degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology Other 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 process Availability for domestic and international travel including overnight stays Skills:
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 organizations Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement Precision 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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