About this role
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