Country Trials Manager, Fsp

Country Trials Manager (CTM)

The Country Trials Manager (CTM) is responsible for study startup deliverables for assigned studies at a country level of limited or moderate complexity. The Country Trials Manager partners with the Study Start Up Project Manager (SUPM), Study Manager (SM), Site Intelligence Lead, Site Relationship Partner (SRP), Site Activation Partner (SAP), Contracts Lead, Regulatory Affairs, CRO representatives and others as required. The Country Trials Manager provides leadership and country strategic planning and organization skills to ensure the delivery of operational Start up aspects of one or more studies, in accordance with the appropriate quality standards including ICH/GCP standards, SOPs, local operating guidelines and local regulatory requirements, as applicable.

Accountable For The Execution Of

• Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level
• Country level implementation of Startup and Site Activation Plans
• Timely and quality Ethics Committee (EC)/Regulatory Authority (RA) Submissions
• Country level Recruitment Strategy

Responsible for Study and Site Start Up on a Country level:

• Attendance at SSU meetings. Ad-hoc member of the Operational Study Team Meetings
• Leader of the Local Study Team (core members: Country Trials Manager, Site Relationship Partner, Site Activation Partner, ad hoc members: Contracting, Regulatory, Medical Affairs colleagues and other key stakeholders as required)
• 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
• Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
• Supports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirements
• Manages country level Significant Quality Events occurring during Site and Study Startup
• Liaise with Global Site and Study Operations (GSSO) and Regulatory colleagues and country colleagues to agree on submission strategy to Health Authorities and Ethic Committees
• Provides input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures Client Trial Master File (PTMF) completeness and oversight of all relevant compliance activities for allocated studies
• May act as a Subject Matter Expert on Client systems and processes
• Ensures compliance to relevant Global and Local, internal and external processes
• Ability to successfully liaise with global roles in support of successful CT (clinical trial) implementation at a country level
• Highlights deviations and risks in startup and site activation plans to relevant parties, develops and implements mitigation strategies as required. Is also accountable for resolution of Site Activation escalations to Study Teams including offering options for mitigation (both at the study and site level.
• Provides country level input on Startup and Recruitment milestones to Global Study Team during planning
• Leads effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
• Manages the study start up (SSU) process in countries assigned
• Is accountable for delivery of startup and site activation 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)
• Ensures audit/Inspection readiness during start-up
• Provides Global Teams with local intelligence. Acts as the main point of contact for all study-level questions for the Local Study Team, liaising with and escalating to appropriate global roles/teams Follows up on country level issue status to ensure resolution. Identifies start up country level trends to improve start up processes as needed

Responsible for Study and Site Start Up Country Operational aspects:

• Country and site level PTMF setup
• Country level investigational product (IP)/equipment/ancillary supplies management including Import/Export License management
• Support to Ethics Committee/Regulatory Authority (EC/RA) and other relevant (e.g., identification of National coordinators, radiation, biobanking) submissions and deficiency/query responses for initial and subsequent Clinical Study Agreement (CSA) submissions
• Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) report review
• Provides support for the Investigator Initiation Package (IIP) process to Site Activation Partner
• Supports Clinical Study Agreement and budget negotiations and setup of site payment tools
• Country level informed consent document (ICD) creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable
• Provides country level documents to PTMF and Investigator Site File (ISF) and ensures country level PTMF completeness during study startup
• Collects Country level documents [e.g., Insurance documents, Letter of Agreement (LOA) if required] required for submission/SIVs
• Supports implementation of new tools and technologies (e.g., eConsent, eISF, Remote Source Access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options, etc.)
• Investigator Meeting support
• Identify/contract/Manage/Oversee local vendors or facilities as per protocol
• Supports with implementation of Client's Site Technology Experience systems [e.g., Shared Investigator Platform (SIP), Centralized Account Management (CAM)]