Clinical Trial Manager - maternity cover

Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Our proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and is clinically demonstrated to safely and potently harness the power of the immune system.Job titleClinical Trial Manager for a maternity cover.OverviewThe Clinical Trial Manager directs and/or supports the planning and conduct of clinical trials (phase I to III), in-house and outsourced to a Contract Research Organization (CRO), in compliance with company processes, ICH-GCP and regulatory requirements. Responsibilities include CRO management and vendor oversight of outsourced activities, coordination and participation in co-monitoring of clinical trials, and performing assigned responsibilities to ensure timely achievement of departmental goals and objectives related to clinical trials.ResponsibilitiesParticipates in the CRO selection process and periodic CRO/vendor performance assessmentContributes to development of clinical study protocols, trial budgets and project plansContributes to country and site selection for clinical trialsAssists in planning and operational execution of clinical trial supply needsTakes responsibility in maintenance of clinical trial registries and related databasesServes as point of contact to CRO and vendorsMaintains a strong knowledge of the protocol and study proceduresReviews and prepares study plans and manuals (Patient Information Sheet and Informed Consent Form, Project Plan, Monitoring Plan, Communication Plan, Pharmacy Manual, Investigator Site File, etc.)Approves country/site PIS/ICF prepared by CRO and oversees timely PIS/ICF implementation on site levelDevelops and implements Vendor Oversight Management Plan (VOMP)Leads and/or supports preparation and conduct of bid-defense, kick-off, SMB and investigator meetingsEnsures that essential documents are in place prior to site initiation and release of Investigational Medicinal Products (IMP) to sitesConducts co-monitoring visits and reviews monitoring visit reportsDevelops study status trackers and reportsProvides updates of study status to supervisor and senior managementEnsures CRO and vendor oversight in compliance with VOMPPerforms periodic review of protocol deviations, risks and issues to identify trends, quality/compliance concerns or any other areas for improvement and initiates appropriate actions with CRO/vendor and as required in cooperation with CTL and/or Quality AssuranceParticipates in performance assessments, audits and Health Authority inspectionsFacilitates resolution of trial related issues through communication with site personnel and/or clinical trial vendors, including central labs, monitoring CROsInteract with internal functions to ensure appropriate performance in execution of delegated activitiesSet-up, maintenance and quality check of eTMFSupport set-up of relevant systems for clinical trials such as EDC, IRT, eTMF, RACT, etc.Set-up and maintenance of trial related Share PointsMaintains knowledge of regulations, guidelines, policies and practices for clinical trialsParticipates in periodic review and development of corporate/departmental SOPs and policiesActs as Subject Matter Expert within Clinical Team as requiredResponds to stakeholder requestsJob RequirementsBachelor’s degree or equivalent qualification in life science/healthcare (Master’s degree is preferred)>5 years of progressively increasing clinical research experience within the pharmaceutical/CRO industry preferably in clinical operations in oncologyMonitoring experience in oncology clinical trialsExperience in management of clinical trialsExperience with health authority inspections (FDA and/or EMA) preferredThorough knowledge of drug development regulations (ICH-GCP, FDA, EMA and local regulations)Working experience in a global team, team playerStrong interpersonal and leadership skillsExcellent problem solving and team building skillsAbility to work independently and in a team environmentGood organizational and time management skillsAbility to work under pressure and meet deadlinesAbility to write in a clear, focused and concise mannerFluent in spoken and written EnglishAs part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us.Nouscom is an equal opportunity employer. We welcome applications from all individuals. We are committed to treating all applicants fairly and avoiding discrimination. #J-18808-Ljbffr