Summary
The Clinical Project Manager plays a crucial role in facilitating the delivery of the sponsor's assets into the clinic. This position requires a blend of adeptness in clinical project management, site monitoring, and external stakeholder management. The ideal candidate must be flexible, possess a willingness to problem-solve under time constraints, and express an enthusiasm for learning new tasks outside the traditional clinical PM/CRA role. The role will collaborate closely with the Australian Clinical Operations manager, cross-functional teams, vendors, and investigative sites to support the efficient conduct of clinical trials.
Main Duties and Responsibilities
Execute on the clinical development strategy in Australia.Work in partnership with the local CRO and the ARTBIO in-house clinical operations, quality, technical operations, and regulatory team to provide oversight, training, and management of Australian clinical sites performing ARTBIO-sponsored clinical studies.Work as the local representative for submissions to regulators and for the identification of clinical sites.Work in partnership with the management team to build out the local network of KOLs, radiopharmacy, and theranostic centers who can recruit, administer RLTs, and conduct studies in Australia.Work with the business development and management team to keep abreast of the local environment and competitive landscape.Will serve as the second employee for the newly established legal entity in Australia (early 2025).Flexibility with working hours to accommodate meetings and timelines when needed due to global business needs.Clinical Project Management and Monitoring
Contributes to the development of study-related documentsSupports the collection of regulatory documentsSupport site selection, start-up, and set up of drug supply and manufacturingSupport site and vendor training in Australia for ARTBIO-sponsored clinical studiesParticipate in the preparation of regulatory and ethical submissions at both country and site levels, compiling responses to authorities' inquiries, and providing support throughout the entire process until approval is securedEnsures appropriate country/site insuranceSupports data review meetingsParticipates in SAE reconciliationProvides regular status reports to stakeholdersPerforms clinical monitoring to ensure quality dataWrites monitoring trip reports Follows up on outstanding eCRFs and data queriesOversees the resolution of study conduct issuesAddresses site issues found during auditsAssist clinical development colleagues in compiling materials and data to support safety meetingsSupports recruitment and retentionSupports data quality, including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected non-compliance by site
Qualifications
A university degree (Bachelor's/Master's or higher qualification) in life sciences or nursing is requiredMinimum of 2 years’ experience in clinical operations (project management) is required (in oncology/radiopharmaceutical clinical trials)
Knowledge, Skills & Abilities Required
Knowledge and understanding of Good Clinical Practices and ICH Guidelines, and other relevant regulatory requirementsCross-functional understanding and knowledge of drug developmentStrong written, verbal communication, and presentation skillsDisease/therapeutic area knowledge in the oncology and RLT spaceProject management/organisational skills to manage timelines and budgetsSolid computer skills of MS applications (e.g., Word, Excel, PowerPoint)Study tools, including electronic system skills (e.g., eTMF, EDC, etc.)Strong interpersonal skills & conflict resolution abilitiesTakes initiativeDetail orientedAbility to adapt and contribute in a fast-changing environmentExecutes responsibilities independentlyEffectively interacts with internal and external partiesEncourages and supports innovationContributes to maintaining a positive company cultureActs as a role model for others in driving the company’s vision
About Us
Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.
The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital.
Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work.
EEO Statement
ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Questions and Application Process
If interested, please apply and send your CV to
HR@artbio.com. All inquiries are treated confidentially.
ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.
