Senior Project Specialist
Emmes Global
- Bangalore, Karnataka
- Permanent
- Full-time
- Supports Global Project Manager (GPM) responsibilities to ensure the contracted services are in accordance with the executed contract and Client/Study expectations.
- Acts as a secondary point of contact in with study vendor(s). Supports vendor management to ensure effective oversight of third-party vendors.
- Contributes to project milestone tracking and schedule management. \
- Supports GPM in project resource requests and study FTE allocation and tracking.
- Supports GPM in risk management activities.
- Schedules and attends internal and external team meetings. Leads and/or assists GPM in internal team meetings and portions of external team meetings as applicable. Supports agenda preparation and prepares and distributes meeting minutes for internal and external meetings. \
- Assists GPM in Facilitating communication between staff and client regarding project development and project processes.
- Extracts information from designated clinical trial management system (CTMS) and other systems/tools to track/analyze study progress for the GPM (e.g., regulatory documents, enrollment, SAE/AEs, protocol deviations, supplies, ethics approvals, data queries) along with coordinating and drafting status reports for internal and external stakeholders.
- Supports project administrative activities for internal and external audits.
- Oversees TMF activities to ensure the TMF is maintained in inspection ready state. Tasks include but are not limited to: tracking of quality and status of document filing, timeliness of document filing, collaborate with TMF group to ensure contemporaneous TMF maintenance.
- Assists the GPM with project financial management activities including monthly projections and budget tracking.
- Develops study documents and plans, using project-specific knowledge.
- Establishes and maintains procedures and processes (e.g., SOPs, work practices) in conjunction with departments and broader Company. May also contribute to corporate SOP development.
- Performs periodic review of allocated project specific internal business records and associated project TMF as needed.
- Serves as administrator of shared workspace and Emmes Systems for assigned projects.
- Assists with onboarding, offboarding, and training records for project staff.
- Manages document retention and archive of project.
- Provides oversight of Project Specialists and Clinical Project Coordinators.
- Performs other duties as assigned.
- Bachelor’s Degree or equivalent qualification.
- Minimum 6 years of relevant project or administrative support experience. Required Skills/Abilities
- Strong familiarity and working knowledge of Microsoft Office applications, particularly MS Word, Excel, SharePoint, Teams and Emmes systems.
- Strong analytical skills.
- Must be able to organize and manage workload efficiently and prioritize projects with minimal supervision.
- Must be able to work with minimal supervision to perform work that is varied and should be able to work to tight timelines.