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 skill
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