Innova Solutions Inc.
Clinical Trial Manager - Research
Innova Solutions Inc., San Francisco, California, United States, 94199
Job ID: 981991 South San Francisco, California Job Type: Contract Added - 08/28/24Job Description
Innova Solutions is immediately hiring for a
Clinical Trial Manager .Position type: Full-time ContractDuration: 6 months with possibility to extendLocation: Hybrid role in South San Francisco, CAAs a
Clinical Trial Manager
you will:The Clinical Trial Manager (CTM) is responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The CTM will focus on the management and support of multinational, multicenter, Phase II studies and may assume responsibility for additional studies/indications as they become available. The CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and determines how to use resources to meet schedules and goals.This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. This role works on issues of diverse scope where the analysis of situation or data requires evaluation of variety of factors including an understanding of current business trends. The CTM will be responsible for managing various project goals and supporting delivery of a quality study on time and within budget.Responsibilities and Duties
Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).Provides oversight and direction to the CRO and service providers providing regional and/or global study services.Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.Participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.Identifies potential study issues/risks, escalates as needed and recommends/implements solutions.Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data clean up.Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization.May have some responsibility for the oversight and management of the study budget including site and service provider budgets.Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.Ensures oversight of data and information in study specific systems e.g., EDC, CTMS, eTMF is current and accurate.May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.Other supportive duties as assigned to achieve operational objectives.Core Competencies, Knowledge and Skill Requirements
In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.Remote based position with occasional travel to the South San Francisco office (flexible).Requirements
Education
Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).Experience
Minimum of 7 years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope.Minimum of 3 years study management experience in clinical and drug development.Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.Experience in supporting SOP development and implementation is desired.Experience working on global teams is desired, Asia-Pacific and EU highly preferred.Qualified candidates should
APPLY NOW
for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
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Innova Solutions is immediately hiring for a
Clinical Trial Manager .Position type: Full-time ContractDuration: 6 months with possibility to extendLocation: Hybrid role in South San Francisco, CAAs a
Clinical Trial Manager
you will:The Clinical Trial Manager (CTM) is responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites. The CTM will focus on the management and support of multinational, multicenter, Phase II studies and may assume responsibility for additional studies/indications as they become available. The CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and determines how to use resources to meet schedules and goals.This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH/GCP, Country specific regulatory guidelines, company goals, and budgets. This role works on issues of diverse scope where the analysis of situation or data requires evaluation of variety of factors including an understanding of current business trends. The CTM will be responsible for managing various project goals and supporting delivery of a quality study on time and within budget.Responsibilities and Duties
Leads and coordinates global cross-functional study teams through all study stages (start-up, conduct, close-out).In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers, budgets and proposals, conduct bid defense meetings, award services, negotiate and execute complex agreements (i.e., CRO, study related collaboration agreements).Provides oversight and direction to the CRO and service providers providing regional and/or global study services.Assists with Inspection Readiness activities which may require the development, modification and/or implementation of policies as needed to ensure high quality and integrity in all study activities.Participates in the development and review of study documents including, but not limited to, CRF design, project plans, Service Provider Oversight plans, TMF plan.Follows processes and procedures and recommend changes to SOP’s and policies to ensure comprehensive and compliant processes in the clinical operations organization.Identifies potential study issues/risks, escalates as needed and recommends/implements solutions.Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data clean up.Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization.May have some responsibility for the oversight and management of the study budget including site and service provider budgets.Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.Ensures oversight of data and information in study specific systems e.g., EDC, CTMS, eTMF is current and accurate.May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.Other supportive duties as assigned to achieve operational objectives.Core Competencies, Knowledge and Skill Requirements
In-depth understanding of FDA and EU regulations, ICH Guidelines and GCP requirements governing the conduct of clinical trials.Remote based position with occasional travel to the South San Francisco office (flexible).Requirements
Education
Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).Experience
Minimum of 7 years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope.Minimum of 3 years study management experience in clinical and drug development.Experience in selecting, managing, and overseeing sites, CROs, specialty labs and other service providers in global, multinational studies or programs.Experience in supporting SOP development and implementation is desired.Experience working on global teams is desired, Asia-Pacific and EU highly preferred.Qualified candidates should
APPLY NOW
for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
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