h3Work Schedule /h3pStandard (Mon-Fri) /ph3Environmental Conditions /h3pOffice /ph3Job Description /h3pJoin Us as a Senior Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation /ppWe have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. /ppAs part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Senior Clinical Trial Coordinator, you'll coordinate and facilitate project activities . You will act as a buddy during the onboarding phase and provide training to new staff as needed. Additionally, you will support departmental and cross-functional initiatives for process improvements and enhancements. /ph3What You’ll Do: /h3ulliAccording to the specific role (Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. /liliPerforms department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. /liliEnsures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate. /liliSupports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system. /liliProvides system support (i.e. GoBalto eTMF). /liliSupports RBM activities.



/liliPerforms administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. /liliSupports scheduling and organization of client and/or internal meetings with completion of related meeting minutes. /liliReviews and tracks local regulatory documents. /liliTransmits documents to client and centralized IRB/IEC. /liliAnalyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. /liliMaintains vendor trackers. /liliAssists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. /liliAssists with study-specific translation materials and translation QC upon request. /liliMay attend Kick off meeting and take notes when required. /li /ulh3Education and Experience Requirements: /h3ulliHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. /liliBachelor's degree preferred. /liliPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years). /li /ulpIn some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience,



will be considered sufficient for an individual to meet the requirements of the role. /ph3Knowledge, Skills and Abilities: /h3ulliAbility to work in a team or independently as required /liliStrong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively /liliProven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency /liliStrong customer focus /liliDemonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines /liliDemonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout /liliExcellent English language and grammar skills and proficient local language skills as needed /liliGood presentation skills /liliExcellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems /liliAbility to successfully complete PPD clinical training program /liliSelf-motivated, positive attitude with effective strong interpersonal skills /li /ulh3Working Conditions and Environment: /h3ulliWork is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. /liliOccasional drives to site locations. Potential Occasional travel required /li /ulpThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p #J-18808-Ljbffr

📌 Clin Ops Delivery Associate III (Roma)
🏢 Thermofisher Scientific
📍 Roma