Clinical Project Manager at ARTBIO

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 documents • Supports the collection of regulatory documents • Support site selection, start-up, and set up of drug supply and manufacturing • Support site and vendor training in Australia for ARTBIO-sponsored clinical studies • Participate 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 secured • Ensures appropriate country/site insurance • Supports data review meetings • Participates in SAE reconciliation • Provides regular status reports to stakeholders • Performs clinical monitoring to ensure quality data • Writes monitoring trip reports • Follows up on outstanding eCRFs and data queries • Oversees the resolution of study conduct issues • Addresses site issues found during audits • Assist clinical development colleagues in compiling materials and data to support safety meetings • Supports recruitment and retention • Supports 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 required • Minimum 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 requirements • Cross-functional understanding and knowledge of drug development • Strong written, verbal communication, and presentation skills • Disease/therapeutic area knowledge in the oncology and RLT space • Project management/organisational skills to manage timelines and budgets • Solid 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 abilities • Takes initiative • Detail oriented • Ability to adapt and contribute in a fast-changing environment • Executes responsibilities independently • Effectively interacts with internal and external parties • Encourages and supports innovation • Contributes to maintaining a positive company culture • Acts as a role model for others in driving the company’s vision About Us ARTBIO is redefining cancer care by developing a new class of radioligand therapies (RLT) which harness the power of 212Pb and deliver it directly to the tumor. Targeted RLT is one of the fastest growing areas of oncology research and investment.  The foundational technology, termed AlphaDirect™, was born out of elegant research by our scientific founders, Roy Larsen and Øyvind Bruland, inventors of XofigoTM.  ARTBIO is leveraging this groundbreaking science and expediting novel Drug Discovery targets which broadly exploit the unmet medical need and opportunity in revolutionising cancer care.  Supported by a committed investment board including Omega Funds, F-Prime Capital, Radforsk and Third Rock Ventures, ARTBIO has built a highly experienced, multi-disciplinary team of drug-hunters and developers. For more information on our strategy and emerging pipeline, please visit www.artbio.com and follow-us on LinkedIn. As an emerging, global biotech with locations in Cambridge, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work.  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.  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 [Upgrade to PRO to see contact]; 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.