Summittherapeutics
Senior Clinical Trial Manager
Summittherapeutics, Miami, Florida, us, 33222
Job Title: Senior Clinical Trial Manager
Department: Clinical Operations
Location: Miami, US
Overview of Role:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.Role and Responsibilities:Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are metInitiates and builds solid professional relationships with key opinion leaders and clinical site staffPartners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on timePartners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality dataProactive identification and management of study related risksResponsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreementsResponsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoringResponsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be metReviews and approves essential document packages to enable timely site activationsReviews pre-study, study initiation, interim monitoring visit and at study closeout visit reportProvides close oversight on the findings on the monitoring reports and loops back with broader team to provide updatesDirects investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessaryResponsible for oversight on the maintenance of the TMF and completeness at the end of the studyPerform periodic QC of the TMFOversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPsEnsures the study is “inspection ready” alwaysResponsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the projectExperience, Education and Specialized Knowledge and Skills:Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred8+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizationPrior phase II and III experience requiredA solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial processExperience with budget forecasting and managementExperience with clinical studies in oncologyAbility to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)Proven proficiency in overseeing large complex studies being managed in house and by a CRODemonstrated ability to lead teams and work in a fast-paced team environmentExperienced and enjoys building relationships with KOLs and site personnelAbility to successfully engage and work collaboratively with overseas clinical operations team members/colleaguesDemonstrated ability to build and deliver on patient enrollment strategiesExcellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectivesDemonstrated ability to comprehend complex scientific concepts and dataProficient in reviewing and assessing clinical dataPossesses excellent planning, time management & coordination skillsDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programsExperience in working in a small organizationExcellent written and oral communication skillsProficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirableStrong computer and database skillsAttention to detail, accuracy and confidentialityClear and concise oral and written communication skillsExcellent organizational skillsCritical thinking, problem solving, ability to work independently.Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.Communicate effectively and articulate complex ideas in an easily understandable wayWork in a fast-paced, demanding and collaborative environment
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Department: Clinical Operations
Location: Miami, US
Overview of Role:Highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.Role and Responsibilities:Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are metInitiates and builds solid professional relationships with key opinion leaders and clinical site staffPartners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on timePartners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality dataProactive identification and management of study related risksResponsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreementsResponsible for reviewing and managing study related plans, processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoringResponsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be metReviews and approves essential document packages to enable timely site activationsReviews pre-study, study initiation, interim monitoring visit and at study closeout visit reportProvides close oversight on the findings on the monitoring reports and loops back with broader team to provide updatesDirects investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessaryResponsible for oversight on the maintenance of the TMF and completeness at the end of the studyPerform periodic QC of the TMFOversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPsEnsures the study is “inspection ready” alwaysResponsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the projectExperience, Education and Specialized Knowledge and Skills:Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred8+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organizationPrior phase II and III experience requiredA solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial processExperience with budget forecasting and managementExperience with clinical studies in oncologyAbility to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)Proven proficiency in overseeing large complex studies being managed in house and by a CRODemonstrated ability to lead teams and work in a fast-paced team environmentExperienced and enjoys building relationships with KOLs and site personnelAbility to successfully engage and work collaboratively with overseas clinical operations team members/colleaguesDemonstrated ability to build and deliver on patient enrollment strategiesExcellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectivesDemonstrated ability to comprehend complex scientific concepts and dataProficient in reviewing and assessing clinical dataPossesses excellent planning, time management & coordination skillsDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programsExperience in working in a small organizationExcellent written and oral communication skillsProficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirableStrong computer and database skillsAttention to detail, accuracy and confidentialityClear and concise oral and written communication skillsExcellent organizational skillsCritical thinking, problem solving, ability to work independently.Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.Communicate effectively and articulate complex ideas in an easily understandable wayWork in a fast-paced, demanding and collaborative environment
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