Global Sr CTM - Home Based in SPAIN.

Vendor experience requiredSyneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success.

We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.supportive and engaged line management; technical and therapeutic area training; Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesExperience as CTM in the management of global/multiple-countries studies and different types of vendors is required.Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative ChangesBudget: support Project Managers in the creation of overall study budget (working with the contract/budget analyst); support site contract amendments and negotiation; assist with Site Selection and Green Light Letters, if applicableSite/Country Contracts and Budgets: stay informed of progress with CDAs, CSA and site budgets; assist with negotiationfor site contractsFinancial/Payment Management: oversight of site payments and vendor payments, if applicableStudy Budget Financial Reconciliation: draft and facilitate the Clinical Study Budget reviewClinical Study Timelines: Support the planning for the clinical study timelines, finalization and update of clinical study timelines; and manage the study team to meet all timelinesStudy Team Training: Assist/support in the creation/finalization of Study Specific Training (TA training, Compound, Study Design, Vendors, Eligibility, etc); Facilitate training sessions; Assign training as appropriate; assist with creation/finalization of Study Monitor Training materialsSite Training:



Assist Project manager in planning for the Investigator Meeting; presenting at theIM, filing documentation of trainingData Management and Closeout: Review updates to Data Managemet Plan; Interim/Final Db Lock Preparation (drive study DBL completeness); Interim/Final Database Lock Preparation (Responsible for study DBL completeness)Plans: Site Selection Plan, Study-Specific Issue Management Plan, Vendor Oversight Plan, TMF Artifact Map and PlanClinical Supplies: Assess and review of materials by external vendors (lab kits, ePRO devices, eConsent tablets, etc); Investigational Product: responsible for overall study reconciliation of IPVendor Oversight: day to day oversight ofvendorsEstablish Review Committees: creating charter, assisting with member selection, contracting as needed, updating Annual PlanSite Closure Strategy: develop site closure planPatient Recruitment Strategy: assist Project Managers in development of patient recruitment strategy and plan; develop recruitment materials; oversight of TMF health; TMF reconciliation; quarterly TMF reviewRisk Management: initial Risk Assessment and Mitigation Plan (RAMP) and maintain throughout study; responsible for Issue Management throughout the study; quarterly Issues reviewICF and Study Specific Language: responsible for building the study specific ICF incorporating appropriate study specific language and safety languageCTA submissions and approvals: responsible for assisting with agency responsesMeetings: Clinical Study Team meetings,



conducting vendor meetings; responsible for agendasand meeting minutesClinical Trial Management System: Keep CTMS updated at study levelQualificationsBachelor's degree or RN in a related field or equivalent combination of education, training, and experience5 years or more of experience as CTM, managing multiple countries, for regional or general trialsProven vendor management experience.Global study management experience.Experience in Oncology clinical trials.Demonstrated ability to lead and align teams in the achievement of project milestonesDemonstrated capability of working in an international environment.Demonstrated expertise in site management and monitoring (clinical or central)Preferred experience with risk-based monitoringDemonstrates understanding of clinical trial management financial principles and budget managementKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirementsMust demonstrate good computer skillsStrong conflict resolution skillsDemonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.Learn more about Syneos Health. Further, nothing contained herein should be construed to create an employment contract.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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📌 Clinical Trial Manager (Home based) (Barcelona)
🏢 ONA Therapeutics
📍 Barcelona