Clinical Trial Manager
Precision For Medicine - Sydney, Australia
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Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.We are looking for a Clinical Trial Manager (based in Australia/Singapore)Position SummaryServes as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.Essential functions of the job include but are not limited to: Primary clinical point of contact with the clientCollaborate with PM on monthly invoicing and variance management of clinical budgetDevelop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetingsGenerate potential site list from key stakeholders and drive site feasibility processIdentify potential risks to the enrollment targets based on feasibility analysis and site''s contracted commitmentDevelop and finalize the country recruitment/retention strategyDevelop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out proceduresLead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAsAddress all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriateSupport in planning and conducting investigator meetingsReview and/or approve of IP release packagesOversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicableDevelop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverablesGenerate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriateResponsible for eTMF implementation and managementCollaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closureAccountable to assist sites, internal staff and CRAs with the preparation for GCP auditsWork closely with PM for project-specific resourcing issuesEscalate pertinent CRA performance and site compliance issues when necessaryCollaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelinesManage processes for investigational product (IP) including drug accountability and reconciliationWhen a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as neededSupports business development and marketing activities as appropriateMay negotiate site budget and investigator contract with support from the legal department and/or site contracts groupMay review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring planMay be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PMMay perform clinical data review of patient profiles, data listings and summary tables, including query generationMay have line management responsibilitiesMay manages workload of supervised staff with continued assessment and adjustment as neededPerform other duties as assigned by managementQualificationsMinimum Required :Bachelor''s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferredMinimum of 5 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Oncology (Phase I) trial experience in Australia preferredOther RequiredExperience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)Excellent communication and interpersonal skills to effectively interface with others in a team settingExcellent organizational skills, attention to detail, and a customer service demeanorAbility to travel domestically and internationally including overnight staysAny data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Created: 2026-02-20