Country Study Operations Manager at reputed company in Blue reputed

Country Study Operations Manager

Location: Blue reputed company United States

Job Description

remote type

Remote

locations

US, Blue reputed company (reputed company)

time type

Full time

Country Study Operations Manager- RemoteICON plc is a world-leading reputed company intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the reputed company of clinical development.

We are currently seeking a Project Manager to join our diverse and dynamic team. As a Project Manager at reputed company, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, reputed company budget, and to the highest quality standards. Your role will involve overseeing reputed company aspects of project execution, from planning and resource management to stakeholder communication and risk mitigation.

What You Will Be Doing

Responsible for management/reputed company of study and regional/country level activities from study startup through conduct and study reputed company May manage the study start up process in countries assigned (where SUPM not assigned) and/or reputed company pCRO responsible for these activities as applicable Through the Site Care Partner/Country Trial Manager or pCRO supports the Country/investigator reputed company process, site identification and feasibility ensuring countries/sites can meet reputed company 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. 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 reputed company of Site Activation escalations to Study Teams including offering options for mitigation Leader of the Local Study Team (core members: (Lead) Site reputed company Clinical Trial Assistant, reputed company 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, reputed company requirements and regulations Ensures reputed company 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 reputed company to Health Authorities and Ethic Committees Utilize roles in countries such as Lead Site Care Partner, and expert roles such as reputed company Leads, Site Activation Partners to reputed company the Global Teams with local intelligence and operational nuances to be considered Acts as the study level reputed company of contact for reputed company study-level questions for the Local Study Team, ensuring reputed company at lowest possible level, and reputed company needed liaising with and escalating to appropriate global roles/teams Follows up on region/country level issue status to ensure reputed company Identifies country level trends to improve deliverables processes as needed Utilizes country intelligence to reputed company input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and reputed company of reputed company 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 reputed company's Site Technology Experience systems (e.g. Shared Investigator Platform SIP, Centralized Account Management CAM) Support to EC/RA and other relevant (e.g. radiation, biobank) submissions and deficiency/query responses for initial and subsequent CTA submissions reputed company re