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
