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- Country Trials Manager (FSP)
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Country Trials Manager (FSP)
Parexel International Corporation
Hungary, Remote
Position Purpose:
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:
Country level implementation of Startup and Site Activation Plans
Country level Recruitment Strategy
Timely and quality Ethics Committee (EC)/Regulatory Authority (RA) Submissions • Communication with internal stakeholders as listed above to ensure efficient and timely study startup delivery at a country level
Primary Duties:
Responsible for Study and Site Start Up on a Country level:
Manages the study start up (SSU) process in countries assigned
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 to Global Study Team during planning
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)
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.
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
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 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
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
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
Ensures audit/Inspection readiness during start-up
May act as a Subject Matter Expert on Client systems and processes • Manages country level Significant Quality Events occurring during Site and Study Startup
Leads effective site recruitment planning to allow for implementation of plans at the country and site level, consistent with global plan and local targets
Provides input on Country level Per Subject Costs, local vendor costs and other fees where applicable
Responsible for Study and Site Start Up Country Operational aspects:
Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) report review
Supports with implementation of Client's Site Technology Experience systems [e.g., Shared Investigator Platform (SIP), Centralized Account Management (CAM)]
Collects Country level documents [e.g., Insurance documents, Letter of Agreement (LOA) if required] required for submission/SIVs
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
Supports Clinical Study Agreement and budget negotiations and setup of site payment tools
Country and site level PTMF setup • Provides country level documents to PTMF and Investigator Site File (ISF) and ensures country level PTMF completeness during study startup
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
Country level investigational product (IP)/equipment/ancillary supplies management including Import/Export License management
Provides support for the Investigator Initiation Package (IIP) process to Site Activation Partner • 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.)
Identify/contract/Manage/Oversee local vendors or facilities as per protocol
Investigator Meeting support
The Individual:
A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology. In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc; a nursing diploma or associate degree in nursing may also be considered with extensive clinical trial experience
Operational clinical trial experience
Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
Prior Experience Preferred:
+ 5 years of clinical research experience and/or study management/startup project manager experienceo Demonstrated knowledge of site selection, site activation, site readiness interdependencieso Demonstrated knowledge of clinical trial methodology and the drug development processo Demonstrated experience leading cross functional teamso Demonstrated experience in Project Management and Quality managemento Demonstrated experience in a matrix management environment
Expertise in the use of Site Activation tools
Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)
Ability to manage complex processes
Ability to manage in a matrix environment
Risk Identification and Mitigation
Strategic Planning, Analytical and Problem-Solving Skills
Critical Path Analysis
Excellent communication skills, both written and verbal
Ability to adapt to changing technologies and processes
Seeks to develop an integrated view of key issues to shape decisions and strategy development
Proactively manages change by identifying opportunities and coaching self and others through the change
Ability to introduce new ideas and implement them
Effectively overcoming barriers encountered during the implementation of new processes and systems
Builds effective relationships with customers and other stakeholders
Works well across country boundaries, respects communication and cultural differences in interpersonal relationship
Effective verbal and written communication skills in relating to colleagues and associates, both inside and outside of the organization
Job posted: 2023-05-16