Northwestern University
Senior Clinical Research Project Manager
Northwestern University, Chicago, Illinois, United States, 60290
Department:
MED-Cancer CenterSalary/Grade:
EXS/8Job Summary:Manages activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Lead and support studies with high complexity including early phase studies, National trials, investigator initiated studies where our PIs hold the IND and have multiple affiliates. Study Project Manager must apply scientific expertise, strategic thinking, analytical skills, global mindset, and innovative solutions to proactively manage study risks and anticipate challenges. This role is fundamental to the future success of the study and requires you to take overall responsibility for and co-ordination of the risk management analysis, mitigations and reporting during the Start Up phase.Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.Specific Responsibilities:TechnicalPlans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.Serve as the main start up point of contact for both internal and external stakeholders.Take oversight of development and implementation of the start-up strategy with cross functional teams.Provides support to the other project managers around feasibility and financial resourcing tasks during the start up phase.Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.Plan, conduct and close out of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).Lead cross functional study team, Disease Team Meetings, actively manage and track study milestones and critical path activities.Provide regular updates on study status and progress to cross functional teams, stakeholders, and governance bodies.Development of the clinical study design and associated systems and documents; ICF, eCRF, IRT, CSR, etc.Proactively anticipate, identify, and address study related issues and opportunities for innovative solutions and best practices.Single point of contact and decision maker for operational aspects of the study.Point of escalation for any study activation feasibility issues.Initiate and actively participate in creation of innovative solutions and process improvement initiatives beyond his/her studies.Responsible for quality control and inspection readiness at all times.Responsible for risk assessment, mitigation planning and execution.AdministrativePrepare, oversee, and review documents that are related to assigned clinical study (NDA, etc.).Arrange or help in organizing clinical study meetings, as necessary.Ensure the availability of necessary resources for the execution of clinical projects.Answerable to questions and issues brought up by vendors and external consultants.Oversee the pattern and manner in which clinical research study is being conducted.Fully involved in resolving issues; take part in procedure improvement initiatives.Track logistics of samples and communicate those results effectively with the data analysts, etc.Attain clinical study's goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process.Work hand-in-hand with clinical trial managers and document control personnel to manage documents that are related to the clinical study.Analyzes, evaluates & interprets data to determine relevance to research.Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.DataManages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.FinanceMonitor and report on the progress of delegated clinical trials, which includes budgets and timelines.Ensures appropriate allocation & compliance.Coordinates & participates in budgetary negotiations with industry sponsors.SupervisionActs as a mentor in regard to education of junior coordinators and project managers.MiscellaneousPerforms other duties as assigned.Minimum Qualifications:Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; ORSuccessful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience.Supervisory or project management experience required.Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.Minimum Competencies: (Skills, knowledge, and abilities.)Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).2-3 years relevant leadership/management experience.Minimum 2 years of relevant experience with successful delivery of project study start-up.
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MED-Cancer CenterSalary/Grade:
EXS/8Job Summary:Manages activities associated with biomedical &/or social-behavioral research studies considered very complex by the inclusion of several of the following: multiple investigators, teams, sites, sub-contracts, participants, longitudinal assessments/interventions; &/or multi-million dollar budgets. Ensures completion of contract requirements & client specifications. Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Lead and support studies with high complexity including early phase studies, National trials, investigator initiated studies where our PIs hold the IND and have multiple affiliates. Study Project Manager must apply scientific expertise, strategic thinking, analytical skills, global mindset, and innovative solutions to proactively manage study risks and anticipate challenges. This role is fundamental to the future success of the study and requires you to take overall responsibility for and co-ordination of the risk management analysis, mitigations and reporting during the Start Up phase.Please note: Supervisor provides objectives and deadlines. Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures. EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.Specific Responsibilities:TechnicalPlans, develops & implements new processes & protocols to support research studies & maximize/extend study capabilities.Serve as the main start up point of contact for both internal and external stakeholders.Take oversight of development and implementation of the start-up strategy with cross functional teams.Provides support to the other project managers around feasibility and financial resourcing tasks during the start up phase.Oversees completion of study activities per protocol. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patient's treatment and test schedules.Ensures that study protocols are in compliance with appropriate rules & regulations & reviews study progress and recommends revisions, amendments, and/or other study changes as necessary to better meet needs of sponsors.Manages conduct of experimental tests & procedures. Closely monitors & documents patient's adverse events; partners with nursing staff in modifying dosages, tests & treatment schedule.Plan, conduct and close out of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).Lead cross functional study team, Disease Team Meetings, actively manage and track study milestones and critical path activities.Provide regular updates on study status and progress to cross functional teams, stakeholders, and governance bodies.Development of the clinical study design and associated systems and documents; ICF, eCRF, IRT, CSR, etc.Proactively anticipate, identify, and address study related issues and opportunities for innovative solutions and best practices.Single point of contact and decision maker for operational aspects of the study.Point of escalation for any study activation feasibility issues.Initiate and actively participate in creation of innovative solutions and process improvement initiatives beyond his/her studies.Responsible for quality control and inspection readiness at all times.Responsible for risk assessment, mitigation planning and execution.AdministrativePrepare, oversee, and review documents that are related to assigned clinical study (NDA, etc.).Arrange or help in organizing clinical study meetings, as necessary.Ensure the availability of necessary resources for the execution of clinical projects.Answerable to questions and issues brought up by vendors and external consultants.Oversee the pattern and manner in which clinical research study is being conducted.Fully involved in resolving issues; take part in procedure improvement initiatives.Track logistics of samples and communicate those results effectively with the data analysts, etc.Attain clinical study's goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process.Work hand-in-hand with clinical trial managers and document control personnel to manage documents that are related to the clinical study.Analyzes, evaluates & interprets data to determine relevance to research.Prepares results & may co-author scientific papers for presentation & publication & disseminates information via seminars, lectures, etc.Acts as liaison between sponsoring agencies, collaborating organizations &/or other research &/or educational institutions.Ensures that all study documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols are completed in a timely manner.DataManages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Partners with internal/external project and IT staff to create, review, analyze, interpret, summarize and prepare progress & final reports.Provides consultation to internal/external project staff on appropriate data management, methodological issues and analysis of data.FinanceMonitor and report on the progress of delegated clinical trials, which includes budgets and timelines.Ensures appropriate allocation & compliance.Coordinates & participates in budgetary negotiations with industry sponsors.SupervisionActs as a mentor in regard to education of junior coordinators and project managers.MiscellaneousPerforms other duties as assigned.Minimum Qualifications:Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience required; ORSuccessful completion of a full course of study in an accredited college or university leading to a master's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience and 5 years' research study or other relevant experience.Supervisory or project management experience required.Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years.Minimum Competencies: (Skills, knowledge, and abilities.)Competent in application of standard business procedures (Standard Operating Procedures, International Conference on Harmonization (ICH), Global Regulations, Ethics and Compliance).2-3 years relevant leadership/management experience.Minimum 2 years of relevant experience with successful delivery of project study start-up.
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