Job description
Title: Clinical Trial Manager
Location: Remote
Status: Contract through end of year
Hourly rate: $100
JOB DESCRIPTION
The Clinical Trial Manager (CTM) is responsible for leading one or more Study Management Teams (SMTs). The CTM is responsible for the day-to-day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites. The CTM is also accountable for ensuring high quality deliverables are within timelines and budget.
• Responsible for the day to day management and oversight of assigned operational aspects, such as CRO/vendor management, drug supply management, clinical sites, etc.
• Lead cross-functional SMT meetings
• Support the Program Lead during the Protocol Development process
• Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
• Conduct protocol and site feasibility assessments
• Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
• In collaboration with Clinical Procurement and Outsourcing, provide leadership in the selection of vendors, including CRO, central lab, imaging, etc.
• Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, Vendor Management Plan, Risk Management Plan, eCRF Completion Guidelines, etc.)
• Provide drug supply assumptions to the clinical planning team • Develop and maintain study timelines, enrollment dashboards, and budgets
• Serve as a liaison and resource for clinical trial sites
• Oversee the creation and maintenance of the Trial Master File
• Perform site initiation, routine monitoring and close-out visits, as well as co-monitoring with CRAs as needed
• Review site visit reports
• Participate in the development, review and implementation of departmental SOPs and processes
Qualifications
Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
• Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams • Working knowledge of ICH Good Clinical Practice guidelines
• Experience with international trials is preferred
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Highly effective verbal and written communication skills
• Must have the ability to build and maintain positive relationships with management, peers and clinical sites
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
• Willing to travel domestically and internationally
Title: Clinical Trial Manager
Location: Remote
Status: Contract through end of year
Hourly rate: $100
JOB DESCRIPTION
The Clinical Trial Manager (CTM) is responsible for leading one or more Study Management Teams (SMTs). The CTM is responsible for the day-to-day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites. The CTM is also accountable for ensuring high quality deliverables are within timelines and budget.
• Responsible for the day to day management and oversight of assigned operational aspects, such as CRO/vendor management, drug supply management, clinical sites, etc.
• Lead cross-functional SMT meetings
• Support the Program Lead during the Protocol Development process
• Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
• Conduct protocol and site feasibility assessments
• Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
• In collaboration with Clinical Procurement and Outsourcing, provide leadership in the selection of vendors, including CRO, central lab, imaging, etc.
• Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, Vendor Management Plan, Risk Management Plan, eCRF Completion Guidelines, etc.)
• Provide drug supply assumptions to the clinical planning team • Develop and maintain study timelines, enrollment dashboards, and budgets
• Serve as a liaison and resource for clinical trial sites
• Oversee the creation and maintenance of the Trial Master File
• Perform site initiation, routine monitoring and close-out visits, as well as co-monitoring with CRAs as needed
• Review site visit reports
• Participate in the development, review and implementation of departmental SOPs and processes
Qualifications
Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
• Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams • Working knowledge of ICH Good Clinical Practice guidelines
• Experience with international trials is preferred
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Highly effective verbal and written communication skills
• Must have the ability to build and maintain positive relationships with management, peers and clinical sites
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
• Willing to travel domestically and internationally
Location: Remote
Status: Contract through end of year
Hourly rate: $100
JOB DESCRIPTION
The Clinical Trial Manager (CTM) is responsible for leading one or more Study Management Teams (SMTs). The CTM is responsible for the day-to-day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites. The CTM is also accountable for ensuring high quality deliverables are within timelines and budget.
• Responsible for the day to day management and oversight of assigned operational aspects, such as CRO/vendor management, drug supply management, clinical sites, etc.
• Lead cross-functional SMT meetings
• Support the Program Lead during the Protocol Development process
• Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
• Conduct protocol and site feasibility assessments
• Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
• In collaboration with Clinical Procurement and Outsourcing, provide leadership in the selection of vendors, including CRO, central lab, imaging, etc.
• Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, Vendor Management Plan, Risk Management Plan, eCRF Completion Guidelines, etc.)
• Provide drug supply assumptions to the clinical planning team • Develop and maintain study timelines, enrollment dashboards, and budgets
• Serve as a liaison and resource for clinical trial sites
• Oversee the creation and maintenance of the Trial Master File
• Perform site initiation, routine monitoring and close-out visits, as well as co-monitoring with CRAs as needed
• Review site visit reports
• Participate in the development, review and implementation of departmental SOPs and processes
Qualifications
Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
• Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams • Working knowledge of ICH Good Clinical Practice guidelines
• Experience with international trials is preferred
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Highly effective verbal and written communication skills
• Must have the ability to build and maintain positive relationships with management, peers and clinical sites
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
• Willing to travel domestically and internationally
Title: Clinical Trial Manager
Location: Remote
Status: Contract through end of year
Hourly rate: $100
JOB DESCRIPTION
The Clinical Trial Manager (CTM) is responsible for leading one or more Study Management Teams (SMTs). The CTM is responsible for the day-to-day management of a clinical trial and oversight of vendors, clinical monitors and clinical trial sites. The CTM is also accountable for ensuring high quality deliverables are within timelines and budget.
• Responsible for the day to day management and oversight of assigned operational aspects, such as CRO/vendor management, drug supply management, clinical sites, etc.
• Lead cross-functional SMT meetings
• Support the Program Lead during the Protocol Development process
• Participate in protocol, eCRF development, and Clinical Study Report preparation, as appropriate
• Conduct protocol and site feasibility assessments
• Identify study risks, develop and implement mitigation strategies; proactively manage the study and associated risks through key risk and performance indicators.
• In collaboration with Clinical Procurement and Outsourcing, provide leadership in the selection of vendors, including CRO, central lab, imaging, etc.
• Oversee the development and review of study-related documents (e.g., eCRFs, Study Reference Binder, Study Management Plan, Vendor Management Plan, Risk Management Plan, eCRF Completion Guidelines, etc.)
• Provide drug supply assumptions to the clinical planning team • Develop and maintain study timelines, enrollment dashboards, and budgets
• Serve as a liaison and resource for clinical trial sites
• Oversee the creation and maintenance of the Trial Master File
• Perform site initiation, routine monitoring and close-out visits, as well as co-monitoring with CRAs as needed
• Review site visit reports
• Participate in the development, review and implementation of departmental SOPs and processes
Qualifications
Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)
• Minimum 4-6 years clinical trial experience with demonstrated ability to lead study teams • Working knowledge of ICH Good Clinical Practice guidelines
• Experience with international trials is preferred
• Able to handle multiple tasks and deadlines
• Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors
• Highly effective verbal and written communication skills
• Must have the ability to build and maintain positive relationships with management, peers and clinical sites
• Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
• Willing to travel domestically and internationally