Work Schedule

Environmental Conditions

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