- 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
