15 feb
Thermo Fisher Scientific
Xico
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.
Escalates in cases of variances (overburn/underburn).
- Supports the maintenance of study specific documentation and systems including, but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
- Provides system (i.E.
CTMS, Oracle Activate & eTMF)
support by managing the access requests, tracking study level documents and maintaining audit readiness.
- Performs administrative tasks on assigned trials including, but not limited to: timely processing of documents sent to CRG's/Client eTMF as required, performing CRG's/Client eTMF 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 and distribution of related meeting minutes.
- Exports and prepares study metrics reports.
- Maintains vendor trackers.
- Assists with coordination and compilation of Investigator Site File (ISF) template and pharmacy binder, with instruction from the Clinical Team Manager.
- When required attends Kick off and Project Launch meetings and takes notes, supports initial study set-up.
- Ability to work in a team or independently as required - Good organizational skills and strong attention to detail,
with proven ability to handle multiple tasks efficiently and effectively - Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency - Strong customer focus - Good time management skills.
Flexibility to reprioritize workload to meet changing project timelines - Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout - Good English language and grammar skills and proficient local language skills (if required).
Effective oral and written communication skills - Good computer skills, proficient in MS Office (Word, Excel,
and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems - Ability to successfully complete CRG training program - Self-motivated, positive attitude and good interpersonal skills
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.