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Country Trials Manager, FSP Clinical Operations

Parexel International Corporation

Multiple Locations

In Parexel we are currently looking for a Country Trials Manager based in France.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 PlansCountry level Recruitment StrategyTimely 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 assignedSupports the Country/investigator outreach process, site identification and feasibility ensuring countries/sites can meet all study protocol requirementsProvides country level input on Startup and Recruitment milestones to Global Study Team during planningIs 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.Liaise with Global Site and Study Operations (GSSO) and Regulatory colleagues and country colleagues to agree on submission strategy to Health Authorities and Ethic CommitteesProvides 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 neededEnsures compliance to relevant Global and Local, internal and external processesAbility to successfully liaise with global roles in support of successful CT (clinical trial) implementation at a country level

Responsible for Study and Site Start Up Country Operational aspects:Pre-Trial Assessment (PTA) and Site Initiation Visit (SIV) report reviewSupports 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/SIVsSupport 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) submissionsSupports Clinical Study Agreement and budget negotiations and setup of site payment toolsCountry and site level PTMF setupProvides country level documents to PTMF and Investigator Site File (ISF) and ensures country level PTMF completeness during study startupCountry level informed consent document (ICD) creation and Global Review and Approval Form (GRAF) completion and site level ICD creation and GRAF completion, if applicable

The Individual:A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodologyOperational clinical trial experienceWorking knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibilityFluency in English and region/country local language are required+ 5 years of clinical research experience and/or study management/startup project manager experienceExpertise in the use of Site Activation toolsDetail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)Strategic Planning, Analytical and Problem-Solving SkillsCritical Path AnalysisExcellent communication skills, both written and verbalAbility to adapt to changing technologies and processes

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Job posted: 2022-08-27

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