Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
- Responsible for handling the metrics in various systems.
- 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 inquisitive 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, interpersonal/customers processes and procedures accurately applied at all levels.
- Provide 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, metrics, status and possible challenges with systems
- Act as oversight on eTMF-specific activities, with a preference for team members with current experience as lead on eTMF activities.
- Possess a high level of experience in all eTMF-oriented activities, including filing, file review, running reports to investigate gaps, and preparing eTMF for audits.
- Have experience with eTMF and one or more client eTMF platforms.
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (more than 5 years).
- Extensive expert level Lead PSC experience.
- Experience with clarity including activities like Team tab review, ‘Under Forecast Value change’ column review, reconciliation of clarity to analyse variance with the budget etc..
- Experience with Client Coordination
- Preparing client compliance reports and creating slides for CRA meetings.
- Hands on experience with Audit preparation
- Assisting the Global Project Leader with preparation of Study Plans
