26 oct
|
Thermo Fisher Scientific
|
Madrid
26 oct
Thermo Fisher Scientific
Madrid
Work Schedule¿Es este el puesto que está buscando? Si es así, siga leyendo para obtener más detalles y no olvide enviar su solicitud hoy mismo.Standard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJoin Us as a Senior Clinical Trial Coordinator – Make an Impact at the Forefront of InnovationWe 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.As part of our general 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 and may serve as a study lead, acting as a cross-functional liaison for the project team. 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.What You'll Do:- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.- Ensures 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.- Supports 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.- Provides system support (i.E. GoBalto & eTMF).- Supports RBM activities.- Performs 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.- Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.- Reviews and tracks local regulatory documents.- Transmits documents to client and centralized IRB/IEC.- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.- Maintains vendor trackers.- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.- Assists with study-specific translation materials and translation QC upon request.- May attend Kick off meeting and take notes when required.Education and Experience Requirements:- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.- Bachelor's degree preferred.- Previous experience that provides the knowledge, skills,
and abilities to perform the job (comparable to at least 4 years). In 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.Knowledge, Skills and Abilities:- Ability to work in a team or independently as required- Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively- Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency- Strong customer focus- Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines- Demonstrated 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- Excellent English language and grammar skills and proficient local language skills as needed- Good presentation skills- Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems- Ability to successfully complete PPD clinical training program- Self-motivated, positive attitude with effective strong interpersonal skillsWorking Conditions and Environment:- Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. xohynlm- Occasional drives to site locations. Potential Occasional travel required
📌 Clinical trial coordinator - fsp - spain (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid