Job Description

　　Responsible for managing the metrics in various systems. • When assigned as Lead, coordinates and supports assigned PSS staff and works closely with functional leads to ensure optimal operational performance. • Helps study teams to maintain audit readiness by bringing forward innovative ideas and smart new ways of working. • Supports creation, implementation and change management for departmental and cross-functional process improvements/enhancements initiatives. • Supports with risk assessment and analysis to avoid possible deviations and noncompliance with established processes. • Provides end to end oversight and follow up on study level activities aiming to minimize any inconsistencies in terms of compliance with systems, organizational/customers processes and procedures accurately applied at all levels. • Provides reconciliation, oversight and follow up on systems and trainings for various Functional Departments. Direct communication with Functional Leads to follow up and increase training compliance >99% on study level. • Attends (if required) external meetings & teleconferences with clients. Supports with preparation of presentations including information about Key Performance Indicators (KPI), metrics, status and possible challenges with systems. • Provides oversight of metrics in CRG's VV eTMF and Client eTMFs; reconciliation of File Reviews. • Updates and maintains trackers and data repositories as required. Assesses/analyzes results and creates potential action plans suggested to Project Lead/CTM. • Provides Clarity support with review of actual hours coded each month to identify miscoding; evaluates spend compared to budget. • Identifies risks and communicates in advance to Functional Leads and Client representatives. • Additional duties may be assigned to provide support to the study teams based on business needs and/or to meet overall objectives of the department/company. - Very good understanding of PSC tasks, applicable PSCs' and other manuals, eTMF and File Review processes, client-specific manuals, procedures and requirements • Audit/inspection process awareness with relevant rules and guidance documents • Expert knowledge of an application (e.g. Excel), system or process • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Analytical skills, ability to comprehend and analyze data, tables, etc. • Strong customer focus • Flexibility to reprioritize workload to meet changing project timelines • Knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle • Advanced English (verbal & written) • Good computer skills, proficient in several MS Office (Word, Excel, Power Point) and ability to obtain knowledge and master all clinical trial database systems • Strong collaborators, very good communication skills, capable to shift prioritization according to project needs and timelines • Ability to work in a team or independently as required • Good negotiation skillThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.