12 feb
Thermo Fisher Scientific
Xico
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/clienst,
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).
- SupportsRBM activities.
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documentssent 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.
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 skills
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