Job Description

Work Schedule Second Shift (Afternoons)Environmental Conditions Office

• Coordinates, oversees and completes functions on assigned trial activities detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Follows up for resolution of findings and escalates whenever necessary.
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Escalates in cases of variances (overburn/underburn) for self and junior PSCs, reviews and re-distributes the tasks based on junior PSCs free capacity (in case involved in a Lead role).
• Supports the maintenance and oversight 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.
• Provides system (i.e. CTMS, Oracle Activate & eTMF) support by managing the access requests, tracking study level documents, maintaining audit readiness and communicating the non-compliance to the study team and suggesting resolution.
• 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 and coordinating and proposing issue resolution, 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 and follow up for closure of action items, if required.
• Exports and reconciles study metrics reports, and if required analyzes and identifies issues (if involved in a Lead role.
• Maintains and regularly checks for correctness of vendor trackers.
• Drives and coordinates the compilation of Investigator Site File (ISF) template, pharmacy binder with instruction from the Clinical Team Manager.
• Attends Kick off and Project Launch meetings and takes notes when required, supports initial study set-up.

Education and Experience:High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).Knowledge, Skills and Abilities:\xc2\xb7 Ability to work in a team or independently as required\xc2\xb7 Strong organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively\xc2\xb7 Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency\xc2\xb7 Strong customer focus\xc2\xb7 Excellent time management skills. Demonstrated flexibility to reprioritize workload to meet changing project timelines\xc2\xb7 Demonstrated ability to attain and maintain a good working knowledge of applicable CountryRegulations (if required), ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout\xc2\xb7 Excellent English language and grammar skills and proficient local language skills (if required).Effective oral and written communication skills with the ability to communicate effectively with project team members\xc2\xb7 Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and learn the required clinical trial systems. Good presentation skills.\xc2\xb7 Ability to successfully complete CRG training program\xc2\xb7 Self-motivated, positive attitude and good interpersonal skills

Thermo Fisher Scientific