pNouscom 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.
/ppbr / /ppWe are looking for a strongClinical Trial Manger for a maternity cover.
/strong /ppbr / /ppThe Clinical Trial Manager: /ppDirects and/or supports the planning and conduct of a clinical trial phase I to III, in-house and outsourced to a Contract Research Organization (CRO) in compliance with company processes, ICH-GCP and regulatory requirements; br / /ppParticipates/directs CRO management and vendor oversight of outsourced activities; br / /ppCoordinates and participates in co-monitoring of clinical trials; br / /ppPerforms assignedresponsibilities to ensure timely achievement of departmental goals and objectives related to clinical trials.
/ppbr / /ppstrongResponsibilities /strong /pulliParticipates in the CRO selection process and periodic CRO/vendor performance assessment /liliContributes to development of clinical study protocols, trial budgets and project plans /liliContributes to country and site selection for clinical trials /liliAssists in planning and operational execution of clinical trial supply needs /liliTakes responsibility in maintenance of clinical trial registries and related databases /liliServes as point of contact to CRO and vendors /liliMaintains a strong knowledge of the protocoland study procedures /liliReviews 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.)



/liliApproves country/site PIS/ICF prepared by CRO and oversees timely PIS/ICF implementation on site level /liliDevelops and implements Vendor Oversight Management Plan (VOMP) /liliLeads and/or supports preparation and conduct of bid-defense, kick-off, SMB and investigator meetings /liliEnsures that essential documents are in place prior to site initiation and releaseof Investigational MedicinalProducts (IMP) to sites /liliConducts co-monitoring visits and reviews monitoring visit reports /liliDevelops study status trackers and reports /liliProvides updates of study status to supervisor and senior management /liliEnsures CRO and vendor oversight in compliance with VOMP /liliPerforms periodic review of protocol deviations, risks and issues to identifytrends, 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 Assurance /liliParticipates in performance assessments, audits and Health Authority inspections /liliFacilitates resolution of trial related issues through communication with site personnel and/or clinical trial vendors, including central labs, monitoring CROs /liliInteract with internal functions to ensure appropriate performance in execution of delegated activities /liliSet-up, maintenance and quality check of eTMF /liliSupport set-up of relevant systems for clinical trials such as EDC, IRT, eTMF, RACT, etc.
/liliSet-up and maintenance of trial related Share Points /liliMaintains knowledge of regulations, guidelines,



policies and practices for clinical trials /liliParticipates in periodic review and development of corporate/departmental SOPs and policies /liliActs as Subject Matter Expert within Clinical Team as required /liliResponds to stakeholder requests /li /ulpbr / /ppstrongJob Requirements /strong /ppbr / /ppProfessionalExperience /pulliBachelor's degree or equivalent qualification in life science/healthcare (Master's degree is preferred) /lili br /5 years of progressivelyincreasing clinical research experience within the pharmaceutical/CRO industry preferably in clinical operations in oncology /liliMonitoring experience in oncology clinical trials /liliExperience in management of clinical trials /liliExperience with health authority inspections (FDA and/or EMA) preferred /li /ulpbr / /ppCompetencies Personal Skills /pulliThorough knowledge of drug development regulations (ICH-GCP, FDA, EMA and local regulations) /liliWorking experience in a global team, team player /liliStrong interpersonal and leadership skills /liliExcellent problem solving and team building skills /liliAbility to work independently and in a team environment /liliGood organizational and time management skills /liliAbility to work under pressure and meet deadlines /liliGood communication skills /liliAbility to write in a clear, focused and concise manner /liliFluent in spoken and written English /li /ulpbr / /ppAs 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.
/ppbr / /ppemNouscom is an equal opportunity employer.
We welcome applications from all individuals.
We are committed to treating all applicants fairly and avoiding discrimination.
/em /ppbr / /p

📌 Clinical Trial Manager - Maternity Cover (Lazio)
🏢 NOUSCOM
📍 Lazio