Job Description :

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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:

Bachelors 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

Project Support Specialist