Project Support Specialist

Work Schedule

Environmental Conditions

Job Description

• Responsiblefor handlingthemetrics in various systems.
• Coordinatesandsupportsassigned PSS staffandworkscloselywithfunctional leads toensure optimal operational performance.
• Helps studyteams to maintainaudit readinessby bringingforwardinnovative ideasand inquisitivenewways ofworking.
• Supportscreation, implementationandchangemanagementfor departmentaland cross-functional process improvements/enhancements initiatives.
• Supportswith riskassessmentandanalysis toavoidpossible deviationsandnoncompliancewithestablished processes.
• Providesendtoendoversightandfollowup on studylevelactivitiesaimingto minimizeanyinconsistencies intermsof compliancewith systems, interpersonal/customers processesand proceduresaccuratelyappliedatall levels.
• Provide reconciliation, oversightandfollowup on systemsandtrainingsforvarious FunctionalDepartments.Direct communicationwith FunctionalLeadstofollowupand increasetraining compliance>99%on study level.
• Attends(if required)externalmeetings &teleconferenceswith clients. Supportswith preparation of presentations including informationabout Key PerformanceIndicators, metrics, statusand possible challengeswith 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:

EducationandExperience:

Bachelor's degree orequivalentand relevantformalacademic /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