Clinical Trails Manager
Katalyst Healthcares & Life Sciences | Boston | www.resume-library.com |
Responsibilities:
5+ years CTM experience CNS/Neuro experience (must have) End to end clinical trial experience needed some travel involved 30% Vendor management experience CRO oversight.
The postholder will be responsible for the overall management and oversight of the study, in compliance with the study protocol and international standards of Good Clinical Practice (GCP).
They will work closely with the Chief Investigator(s) and wider multidisciplinary team.
Understanding the requirements of the various ethical and regulatory bodies, agencies and frameworks, guiding the study in conforming to those requirements and co-ordinating any necessary audit processes.
Preparing study materials and establishing procedures to ensure adherence to study protocols and administrative requirements.
Leading on the creation and maintenance of all study files, including the study master file, and oversight of site files.
Leading with the recruitment, training, appraisal, retention and supervision of study team members.
Coordinating applications, and subsequent amendments as applicable, to ethical and regulatory bodies.
Performing site visits to facilitate study set up and initiation, regular monitoring visits during patient recruitment, and close out visits on study completion.
Leading study oversight groups (such as study Management Group, study Steering Committee, Data Monitoring Committee) by organizing and facilitating meetings, providing reports and documentation to committees and following upon agreed actions.
Requirements:
Regularly liaising with study sites and other members of the core team (data managers, statisticians, epidemiologists) to ensure follow-up visits data are kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
Ensuring the timely recruitment of study participants with secure randomization processes and subsequent efficient and effective data management.
Ensuring that all study adverse events are appropriately investigated by the study staff and accurately reported to the investigators and regulatory bodies as required.
Monitoring study progress to ensure compliance with and adherence to the study plan and to identify, evaluate and rectify problems.
Supporting investigators in the collection and monitoring of study data and to liaise with collaborators, study doctors and the data manager to ensure that follow-up information is kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
Preparing research progress and monitoring reports for, organize and minute regular meetings with the appropriate Steering Committee and Data Monitoring Committees, as applicable, ensuring compliance with Research Governance, Good Clinical Practice, Data Protection and ethical requirements, as applicable.
Provision of regular and ad-hoc information, both written and verbal, to all the study participants and sponsors, to include reports, updates, guidance, performed commitments and possibly a newsletter, or similar, as appropriate.
Co-ordinating the preparation and publication of data, reports and information, ensuring compliance with applicable contractual and ethical requirements.
Ensuring the inclusion of patients and public involvement and engagement group representatives at the appropriate levels and times.
Acting as the first point of contact for all external and internal agencies.
Any other ad-hoc tasks as requested by the Chief investigator
5+ years CTM experience CNS/Neuro experience (must have) End to end clinical trial experience needed some travel involved 30% Vendor management experience CRO oversight.
The postholder will be responsible for the overall management and oversight of the study, in compliance with the study protocol and international standards of Good Clinical Practice (GCP).
They will work closely with the Chief Investigator(s) and wider multidisciplinary team.
Understanding the requirements of the various ethical and regulatory bodies, agencies and frameworks, guiding the study in conforming to those requirements and co-ordinating any necessary audit processes.
Preparing study materials and establishing procedures to ensure adherence to study protocols and administrative requirements.
Leading on the creation and maintenance of all study files, including the study master file, and oversight of site files.
Leading with the recruitment, training, appraisal, retention and supervision of study team members.
Coordinating applications, and subsequent amendments as applicable, to ethical and regulatory bodies.
Performing site visits to facilitate study set up and initiation, regular monitoring visits during patient recruitment, and close out visits on study completion.
Leading study oversight groups (such as study Management Group, study Steering Committee, Data Monitoring Committee) by organizing and facilitating meetings, providing reports and documentation to committees and following upon agreed actions.
Requirements:
Regularly liaising with study sites and other members of the core team (data managers, statisticians, epidemiologists) to ensure follow-up visits data are kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
Ensuring the timely recruitment of study participants with secure randomization processes and subsequent efficient and effective data management.
Ensuring that all study adverse events are appropriately investigated by the study staff and accurately reported to the investigators and regulatory bodies as required.
Monitoring study progress to ensure compliance with and adherence to the study plan and to identify, evaluate and rectify problems.
Supporting investigators in the collection and monitoring of study data and to liaise with collaborators, study doctors and the data manager to ensure that follow-up information is kept up-to-date, accurately completed and that loss of patient data is kept to a minimum.
Preparing research progress and monitoring reports for, organize and minute regular meetings with the appropriate Steering Committee and Data Monitoring Committees, as applicable, ensuring compliance with Research Governance, Good Clinical Practice, Data Protection and ethical requirements, as applicable.
Provision of regular and ad-hoc information, both written and verbal, to all the study participants and sponsors, to include reports, updates, guidance, performed commitments and possibly a newsletter, or similar, as appropriate.
Co-ordinating the preparation and publication of data, reports and information, ensuring compliance with applicable contractual and ethical requirements.
Ensuring the inclusion of patients and public involvement and engagement group representatives at the appropriate levels and times.
Acting as the first point of contact for all external and internal agencies.
Any other ad-hoc tasks as requested by the Chief investigator
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