Job
Description
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 Overview Sr Project Specialist India Bengaluru/hybrid Emmes Group: Building a better future for us all Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience We believe the work we do will have a direct impact on patients lives and act accordingly We strive to build a collaborative culture at the intersection of being a performance and people driven company We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company If you share our motivations and passion in research, come join us! Primary Purpose The Senior Project Specialist provides support to Emmes Global Project Management teams, determining workflows, providing logistics support for conference calls, meetings, supplies, documentation, problem solving, and client/sponsor reporting needs and interactions as required by the statement of work or other corporate/client/sponsor requirements This position provides oversight to Project Specialists and Clinical Project Coordinators This role supports BioPharma portfolio projects Responsibilities 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 Qualifications 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 CONNECT WITH US! 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