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Clinical Trial Manager

Company: Fusion Pharmaceuticals
Location: Cambridge
Posted on: September 23, 2022

Job Description:

Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Employing a proprietary Fast-Clear--- linker technology, and leveraging the Company's actinium supply and manufacturing expertise, Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966 targeting the fibroblast growth factor receptor 3 (FGFR3) and FPI-2059, a small molecule acquired from Ipsen, targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop up to three novel targeted alpha therapies (TATs), the first of which is currently in IND enabling studies, and explore up to five combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion also recently entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA-- (pembrolizumab) in patients with solid tumors expressing IGF-1R.The Clinical Trial Manager is accountable for providing sponsor oversight to the site management activities of phase I-II clinical trials outsourced to a Contract Research Organization (CRO) from trial planning through study closeout, in compliance with Fusion processes, ICH GCP and regulatory requirements.Key Responsibilities include but are not limited to:Contributes to trial planning and designs site management processes from study start-up to closure in collaboration with CRO and Clinical Trial Team (CTT) meeting the requirements of the protocol and Fusion standardsSet-up of performance metrics to oversee and monitor the performance of CRO and site activitiesParticipates in trial risk assessment and management activities; recognizes potential challenges within the protocol and operational aspects of the trialParticipates in the CRO selection process and approves key CRO site management staffMaintains a strong knowledge of the protocol and study procedures to be able to answer operational questions from CROContributes to and reviews study plans and documents (e.g., Drug Handling Manual, trial-level Informed Consent Forms (ICFs))Approves country/site ICF customizations prepared by CRO and oversees timely ICF implementation on site levelReviews and approves CRO monitoring plan, monitoring visit report annotations and Investigator Site File templates prepared by CRODevelops and implements Site Management Oversight PlanSupports operational trial feasibility and approves sites recommended by CRO for trial participationProvides training on the protocol and key trial elements together with the Clinical Trial Manager (CTM) to the CRO site management team as needed and drives any other activities that support site selection and recruitmentEnsures that all essential documents are in place for approval of site initiation and release of Investigational Medicinal Products (IMP) to the sitesPerforms periodic review of protocol deviations, site issues and monitoring visit reports to identify trends, quality/compliance concerns or any other areas for improvement and initiates appropriate actions with CRO site management team and as required with CTL and/or Quality AssurancePerforms co-monitoring visits with the CRO CRA in compliance with annual co-monitoring planProvides governance on site-specific TMFs maintained by the CROCommunicates with CRO site management team on a regular basis to assure proper adherence to protocol, study plans, timelines, and other trial related topicsParticipates in CTT meetings as a core memberParticipates in internal audits and HA inspections as requiredCoaches new CTMs during their onboarding as assignedActively contributes or leads process improvement or acts as Subject Matter Experts Qualifications > 4 years pharmaceutical industry experience with 3-5 years strong experience in clinical research in a field monitor role or a role overseeing clinical trialsthorough knowledge of Good Clinical Practice, regulatory processes, and clinical trial processExperience with health authority inspections (FDA and/or EMA) preferredStrong Project Management and leadership skillsStrong interpersonal skillsHighly proficient in negotiation skillsWorking experience in a global team, team playerAbility to work in a matrix environmentAbility to work under pressureHighly effective in influencing othersDisplays innovative ideas and solutions All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual, gender identity, national origin, disability, or status as a protected veteran.Fusion requires all employees to be current with their COVID vaccination requirements. PDN-9746a119-1c85-4cb3-ba06-5ab41f59ff71

Keywords: Fusion Pharmaceuticals, Cambridge , Clinical Trial Manager, Executive , Cambridge, Massachusetts

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