Clinical Trial Coordinator - Fsp - Spain (Madrid)

Clinical Trial Coordinator - Fsp - Spain (Madrid)

27 oct
|
Thermo Fisher Scientific
|
Madrid

27 oct

Thermo Fisher Scientific

Madrid

Work ScheduleStandard (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 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 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 integral 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. - Occasional drives to site locations. Potential Occasional travel required

📌 Clinical Trial Coordinator - Fsp - Spain (Madrid)
🏢 Thermo Fisher Scientific
📍 Madrid

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