Blue Bell, PA30+ days ago
timelines, budget, risk and quality plans) • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required • Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation Leader of the Local Study Team (core members: (Lead) Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required) Ensures compliance to relevant Global and Local, internal and external requirements and regulations Ensures timely communication bidirectionally between the global and local study team Provides protocol level guidance and support to responsible Local Study Team members as applicable Liaise with Site Care Partner, Lead Site Care Partner, Site Activation Partners and Regulatory colleagues in country to agree on submission strategy to Health Authorities and Ethic Committees Utilize roles in countries such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams Follows up on region/country level issue status to ensure resolution Identifies country level trends to improve deliverables processes as needed Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies Ensures audit/Inspection readiness during start-up and conduct Manages applicable Quality Events with pCRO and local team as applicable and required Coordinates effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets Responsible to drive and ensure delivery of data cleaning deliverables for pCRO and sites as applicable Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable May act as a Subject Matter Expert May lead operational effectiveness initiatives at country or regional level Responsible for PTA and SIV report review for reports completed by the Site Care Partner Supports implementation of client's Site Technology Experience systems (e.g. What You Will Be Doing:
• Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close • May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee pCRO responsible for these activities as applicable • Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements • Provides country level input on Startup and Recruitment milestones as provided by pCRO and/or Country Trial Manager/Site Care Partner to Global Study Manager during planning • Is accountable for overseeing pCRO and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g.