INSPYR Solutions
Senior Global Clinical Operations Lead
INSPYR Solutions, Portland, Oregon, United States, 97229
Title: Senior Global Clinical Operations Lead
Please read the following job description thoroughly to ensure you are the right fit for this role before applying.Location: RemoteDuration: 6+ monthsCompensation: $85.00 – 87.00/hrWork Requirements: US Citizen, GC Holders or Authorized to Work in the U.S.
Senior Global Clinical Operations Lead
The Senior Global Clinical Operations Lead is responsible for the delivery of a clinical study or studies in accordance with the agreed timelines and budget and in good quality (as highlighted in ICH-GCP, SOPs and local regulations). The Senior Lead is responsible for leading the clinical operational planning and study execution for a study/studies with minimal oversight, including complex and/ or bigger size studies. The Senior Lead will study execution team (SET), oversees study level outsourcing, risk and issue identification, takes preventive/corrective action(s) to address these risks and issues. The Senior Lead works closely with the Global Clinical Program Manager (GCPM) and is responsible for timely reporting of study progress, study status and escalations of issues and risks to the GCPM or Head Study Management.
Specific Tasks (including but not limited to): Perform project management for a clinical study and oversee and support planning, execution and closure of the studies/ study from protocol development up to Clinical Study Report completion and Trial Master File (TMF) filing.Contribute to vendor selection and review of vendor budgets and contractsResponsible for vendor management, including issue escalation and oversight of all study level outsourcing activities.Lead the study execution team (SET)Assigns and documents study specific roles and responsibilities to internal and external team membersDevelop, drive and oversee study timelines and study budgetsDevelop study specific documents and plans (such as Study Management Plan) and provide operational input in study documents such as protocol and master ICF.Review country ICFs and site ICFsSupport EC/ IRB submissions and regulatory submissionsProvide input in the proposed feasibility concept, country and site strategy and enrollment planCollaborate with SET team to plan and coordinate all study related activities, including activities related to IMP and supplies and lab.Ensure regulatory and GCP complianceSupports in study level risk identification and takes preventive/ corrective action(s) to address study level risks in collaboration with SETContribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SETResponsible for oversight of TMF, including periodic audits and correct and timely filing to ensure inspection readiness at all timesEnsure SET team and external partners receive study specific trainingDevelop investigator meetings and align with site man group for CRA training devResponsible for reviewing data and data listingsFacilitate study close out activitiesEnsure standard processes, tools and procedures are used consistently for a studyReport key study performance information and metrics, including study start-up metrics, enrollment, data collection timeliness, quality measuresSupport in the development of new SOPs, guidelines etc and/ or participate in working groups about new processesMaintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerationsSupport audits/inspections and resolution of findings
Our benefits package includes: Comprehensive medical benefitsCompetitive pay401(k) retirement plan...and much more!
About INSPYR SolutionsTechnology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.
INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilitiesRemote working/work at home options are available for this role.
Please read the following job description thoroughly to ensure you are the right fit for this role before applying.Location: RemoteDuration: 6+ monthsCompensation: $85.00 – 87.00/hrWork Requirements: US Citizen, GC Holders or Authorized to Work in the U.S.
Senior Global Clinical Operations Lead
The Senior Global Clinical Operations Lead is responsible for the delivery of a clinical study or studies in accordance with the agreed timelines and budget and in good quality (as highlighted in ICH-GCP, SOPs and local regulations). The Senior Lead is responsible for leading the clinical operational planning and study execution for a study/studies with minimal oversight, including complex and/ or bigger size studies. The Senior Lead will study execution team (SET), oversees study level outsourcing, risk and issue identification, takes preventive/corrective action(s) to address these risks and issues. The Senior Lead works closely with the Global Clinical Program Manager (GCPM) and is responsible for timely reporting of study progress, study status and escalations of issues and risks to the GCPM or Head Study Management.
Specific Tasks (including but not limited to): Perform project management for a clinical study and oversee and support planning, execution and closure of the studies/ study from protocol development up to Clinical Study Report completion and Trial Master File (TMF) filing.Contribute to vendor selection and review of vendor budgets and contractsResponsible for vendor management, including issue escalation and oversight of all study level outsourcing activities.Lead the study execution team (SET)Assigns and documents study specific roles and responsibilities to internal and external team membersDevelop, drive and oversee study timelines and study budgetsDevelop study specific documents and plans (such as Study Management Plan) and provide operational input in study documents such as protocol and master ICF.Review country ICFs and site ICFsSupport EC/ IRB submissions and regulatory submissionsProvide input in the proposed feasibility concept, country and site strategy and enrollment planCollaborate with SET team to plan and coordinate all study related activities, including activities related to IMP and supplies and lab.Ensure regulatory and GCP complianceSupports in study level risk identification and takes preventive/ corrective action(s) to address study level risks in collaboration with SETContribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SETResponsible for oversight of TMF, including periodic audits and correct and timely filing to ensure inspection readiness at all timesEnsure SET team and external partners receive study specific trainingDevelop investigator meetings and align with site man group for CRA training devResponsible for reviewing data and data listingsFacilitate study close out activitiesEnsure standard processes, tools and procedures are used consistently for a studyReport key study performance information and metrics, including study start-up metrics, enrollment, data collection timeliness, quality measuresSupport in the development of new SOPs, guidelines etc and/ or participate in working groups about new processesMaintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerationsSupport audits/inspections and resolution of findings
Our benefits package includes: Comprehensive medical benefitsCompetitive pay401(k) retirement plan...and much more!
About INSPYR SolutionsTechnology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.
INSPYR Solutions provides Equal Employment Opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, INSPYR Solutions complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilitiesRemote working/work at home options are available for this role.