Core Project Team Members. Listed below are the members of the Project Team along with a brief description of their relevant experience and respective responsibilities. Curricula Vitae of this project team have been provided to Sponsor under an Appendix to the proposal for these studies, dated 15th September 2006. Knowing that the cooperation between **** and the Sponsor Project team on a previous study has been a success for both sides, we would like to propose to assign her to this trial, too. **** will be responsible for general project oversight and be the main contact for Sponsor for all project-related questions and issues. **** has **** years of clinical research experience having started at Omnicare Clinical Research (formerly Bio-Pharm/IBAH) as a Clinical Research Associate. **** has participated in many large, International trials for such complicated indications as sepsis, nosocomial pneumonia and oncology trials, as both a monitor and manager. She obtained a Bachelor of Science in **** from the State University of ****. **** has received her Masters of Science in **** from ****. Combined with her extensive clinical experience, **** education enables both a strong clinical and management approach to clinical research. **** will be the Clinical Trial Manager for the study. She will be managing the day-to-day clinical trial activities and be responsible for overseeing all site and CRA activity, developing case report forms and monitoring guidelines, overseeing regulatory document management for each investigational site, as well as reviewing and tracking CRA activities which include the scheduling of site visits, site visit reports, monitoring logs, and follow-up correspondence. **** has joined Omnicare in ****, bringing with her a wealth of experience in the pharmaceutical and CRO industry where she has held various positions of increasing responsibility. Her long track record of almost 20 studies includes projects from phase I to phase IV, and therapeutic areas such as cardiovascular diseases, endocrinology, neurology, and **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. respiratory disorders. She also has gained experience in oncology projects and has monitored a dermatology trial. **** is a registered nurse and has been involved in various trials as a nurse, which makes her especially qualified due to her knowledge of both the CRO and site staff side of the project.. As the Data Management Lead, **** will be based in the UK and coordinate all clinical data management activities from there. She will be supported by a Clinical Data Analyst on the study. **** has been with Omnicare for over **** years and has gained experience in a data management role since ****. Her previous therapeutic area experience includes a dermatology project in sun bxxxx, and oncology studies in lung cancer, breast cancer, and skin malignancies. **** will manage and coordinate all internal functional technical service activities, and also be available as a primary point of contact regarding brostatistics issues for Sponsor. He will be an integral member of the project management team within Omnicare and will ensure that consistent information is relayed between Sponsor and the Biometrics team in Australia and the US. **** is based in Sydney and will be available to discuss or provide immediate assistance on issues arising in relation to Statistics, and will also be available to attend teleconferences with Sponsor. **** has been working in the healthcare industry for eight years, and has held statistician and data management roles for the same period. Most notably, **** has worked in the CRO industry since 2001 both in the UK as well as Australia. He brings advanced skills in the data management and statistical analyses of clinical trials from study set-up to database close and reporting of results. **** is experienced in database design, build and management, data validation, medical coding, query resolution, statistical analyses and study design. He has been involved in planning; coordinating and execution of clinical data solutions for many local and global studies. **** is experienced in various database software packages including SAS and Oracle Clinical used in the budgets for the studies to be conducted. He received First Class honors for a Bachelor of Applied Science (****) from the University of **** in **** and also achieved a Bachelor of Applied Science (****) from the same university in ****. As Biostatistics services will be provided from the US and Australia for this project, we propose **** as the Senior Project Statistician in the US. She will cooperate closely with ****. **** has joined Omnicare in **** as a Statistician and has been involved in over ten projects. Her therapeutic experience relevant to the planned Project includes a phase II trial in skin **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. malignancies and a phase III trial in malignant melanoma. **** holds an M.S. degree in **** from the University of ****, ****. **** will be the Director of Clinical Writing for this project. **** will supervise, and direct the clinical writers who will be assigned to the completion of the clinical study report is responsible for approving the final report and ensuring that the clinical writing deliverable of the study are completed in an efficient and timely fashion. Before joining Omnicare CR, **** was a member of the research faculty in the **** and **** at another CRO involving oversight of the data management, biostatistics, and scientific writing departments. **** is a graduate of both the University of **** (B. S. ****) and **** University (M.S., ****, Ph.D., ****). He has a ****, and earned a **** degree from the University of ****.
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Core Project Team Members. Listed below are the members of the Project Team along with a brief description of their relevant experience and respective responsibilities. Curricula Vitae of this project team have been provided to Sponsor under an Appendix to the proposal for these studies, dated 15th September 2006. Knowing that the cooperation between **** and the Sponsor Project team on a previous study has been a success for both sides, we would like to propose to assign her to this trial, too. **** will be responsible for general project oversight and be the main contact for Sponsor for all project-related questions and issues. **** has **** years of clinical research experience having started at Omnicare Clinical Research (formerly Bio-Pharm/IBAH) as a Clinical Research Associate. **** has participated in many large, International trials for such complicated indications as sepsis, nosocomial pneumonia and oncology trials, as both a monitor and manager. She obtained a Bachelor of Science in **** from the State University of ****. **** has received her Masters of Science in **** from ****. Combined with her extensive clinical experience, **** education enables both a strong clinical and management approach to clinical research. **** will be the Clinical Trial Manager for the study. She will be managing the day-to-day clinical trial activities and be responsible for overseeing all site and CRA activity, developing case report forms and monitoring guidelines, overseeing regulatory document management for each investigational site, as well as reviewing and tracking CRA activities which include the scheduling of site visits, site visit reports, monitoring logs, and follow-up correspondence. **** has joined Omnicare in ****, bringing with her a wealth of experience in the pharmaceutical and CRO industry where she has held various positions of increasing responsibility. Her long track record of almost 20 studies includes projects from phase I to phase IV, and therapeutic areas such as cardiovascular diseases, endocrinology, neurology, and **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. respiratory disorders. She also has gained experience in oncology projects and has monitored a dermatology trial. **** is a registered nurse and has been involved in various trials as a nurse, which makes her especially qualified due to her knowledge of both the CRO and site staff side of the project.. . As the Data Management Lead, **** will be based in the UK and coordinate all clinical data management activities from there. She will be supported by a Clinical Data Analyst on the study. **** has been with Omnicare for over **** years and has gained experience in a data management role since ****. Her previous therapeutic area experience includes a dermatology project in sun bxxxxxxxxx, and oncology studies in lung cancer, breast cancer, and skin malignancies. **** will manage and coordinate all internal functional technical service activities, and also be available as a primary point of contact regarding brostatistics issues for Sponsor. He will be an integral member of the project management team within Omnicare and will ensure that consistent information is relayed between Sponsor and the Biometrics team in Australia and the US. **** is based in Sydney and will be available to discuss or provide immediate assistance on issues arising in relation to Statistics, and will also be available to attend teleconferences with Sponsor. **** has been working in the healthcare industry for eight years, and has held statistician and data management roles for the same period. Most notably, **** has worked in the CRO industry since 2001 both in the UK as well as Australia. He brings advanced skills in the data management and statistical analyses of clinical trials from study set-up to database close and reporting of results. **** is experienced in database design, build and management, data validation, medical coding, query resolution, statistical analyses and study design. He has been involved in planning; coordinating and execution of clinical data solutions for many local and global studies. **** is experienced in various database software packages including SAS and Oracle Clinical used in the budgets for the studies to be conducted. He received First Class honors for a Bachelor of Applied Science (****) from the University of **** in **** and also achieved a Bachelor of Applied Science (****) from the same university in ****. As Biostatistics services will be provided from the US and Australia for this project, we propose **** as the Senior Project Statistician in the US. She will cooperate closely with ****. **** has joined Omnicare in **** as a Statistician and has been involved in over ten projects. Her therapeutic experience relevant to the planned Project includes a phase II trial in skin **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. malignancies and a phase III trial in malignant melanoma. **** holds an M.S. degree in **** from the University of ****, ****. **** will be the Director of Clinical Writing for this project. **** will supervise, and direct the clinical writers who will be assigned to the completion of the clinical study report is responsible for approving the final report and ensuring that the clinical writing deliverable of the study are completed in an efficient and timely fashion. Before joining Omnicare CR, **** was a member of the research faculty in the **** and **** at another CRO involving oversight of the data management, biostatistics, and scientific writing departments. **** is a graduate of both the University of **** (B. S. ****) and **** University (M.S., ****, Ph.D., ****). He has a ****, and earned a **** degree from the University of ****.
Appears in 1 contract
Core Project Team Members. Listed below are the members of the Project Team along with a brief description of their relevant experience and respective responsibilities. Curricula Vitae of this project team have been provided to Sponsor under an Appendix to the proposal for these studies, dated 15th September 2006. Knowing that the cooperation between **** and the Sponsor Project team on a previous study has been a success for both sides, we would like to propose to assign her to this trial, too. **** will be responsible for general project oversight and be the main contact for Sponsor for all project-related questions and issues. **** has **** years of clinical research experience having started at Omnicare Clinical Research (formerly Bio-Pharm/IBAH) as a Clinical Research Associate. **** has participated in many large, International trials for such complicated indications as sepsis, nosocomial pneumonia and oncology trials, as both a monitor and manager. She obtained a Bachelor of Science in **** from the State University of ****. **** has received her Masters of Science in **** from ****. Combined with her extensive clinical experience, **** education enables both a strong clinical and management approach to clinical research. **** will be the Clinical Trial Manager for the study. She will be managing the day-to-day clinical trial activities and be responsible for overseeing all site and CRA activity, developing case report forms and monitoring guidelines, overseeing regulatory document management for each investigational site, as well as reviewing and tracking CRA activities which include the scheduling of site visits, site visit reports, monitoring logs, and follow-up correspondence. **** has joined Omnicare in ****, bringing with her a wealth of experience in the pharmaceutical and CRO industry where she has held various positions of increasing responsibility. Her long track record of almost 20 studies includes projects from phase I to phase IV, and therapeutic areas such as cardiovascular diseases, endocrinology, neurology, and **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. respiratory disorders. She also has gained experience in oncology projects and has monitored a dermatology trial. **** is a registered nurse and has been involved in various trials as a nurse, which makes her especially qualified due to her knowledge of both the CRO and site staff side of the project.. . As the Data Management Lead, **** will be based in the UK and coordinate all clinical data management activities from there. She will be supported by a Clinical Data Analyst on the study. **** has been with Omnicare for over **** years and has gained experience in a data management role since ****. Her previous therapeutic area experience includes a dermatology project in sun bxxxxxxxxx, and oncology studies in lung cancer, breast cancer, and skin malignancies. **** will manage and coordinate all internal functional technical service activities, and also be available as a primary point of contact regarding brostatistics issues for Sponsor. He will be an integral member of the project management team within Omnicare and will ensure that consistent information is relayed between Sponsor and the Biometrics team in Australia and the US. **** is based in Sydney and will be available to discuss or provide immediate assistance on issues arising in relation to Statistics, and will also be available to attend teleconferences with Sponsor. **** has been working in the healthcare industry for eight years, and has held statistician and data management roles for the same period. Most notably, **** has worked in the CRO industry since 2001 both in the UK as well as Australia. He brings advanced skills in the data management and statistical analyses of clinical trials from study set-up to database close and reporting of results. **** is experienced in database design, build and management, data validation, medical coding, query resolution, statistical analyses and study design. He has been involved in planning; coordinating and execution of clinical data solutions for many local and global studies. **** is experienced in various database software packages including SAS and Oracle Clinical used in the budgets for the studies to be conducted. He received First Class honors for a Bachelor of Applied Science (****) from the University of **** in **** and also achieved a Bachelor of Applied Science (****) from the same university in ****. As Biostatistics services will be provided from the US and Australia for this project, we propose **** as the Senior Project Statistician in the US. She will cooperate closely with ****. **** has joined Omnicare in **** as a Statistician and has been involved in over ten projects. Her therapeutic experience relevant to the planned Project includes a phase II trial in skin **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. malignancies and a phase III trial in malignant melanoma. **** holds an M.S. degree in **** from the University of ****, ****. **** will be the Director of Clinical Writing for this project. **** will supervise, and direct the clinical writers who will be assigned to the completion of the clinical study report is responsible for approving the final report and ensuring that the clinical writing deliverable of the study are completed in an efficient and timely fashion. Before joining Omnicare CR, **** was a member of the research faculty in the **** and **** at another CRO involving oversight of the data management, biostatistics, and scientific writing departments. **** is a graduate of both the University of **** (B. S. ****) and **** University (M.S., ****, Ph.D., ****). He has a ****, and earned a **** degree from the University of ****.
Appears in 1 contract
Core Project Team Members. Listed below are the members of the Project Team along with a brief description of their relevant experience and respective responsibilities. Curricula Vitae of this project team have been provided to Sponsor under an Appendix to the proposal for these studies, dated 15th September 2006. Knowing that the cooperation between **** and the Sponsor Project team on a previous study has been a success for both sides, we would like to propose to assign her to this trial, too. **** will be responsible for general project oversight and be the main contact for Sponsor for all project-related questions and issues. **** has **** years of clinical research experience having started at Omnicare Clinical Research (formerly Bio-Pharm/IBAH) as a Clinical Research Associate. **** has participated in many large, International trials for such complicated indications as sepsis, nosocomial pneumonia and oncology trials, as both a monitor and manager. She obtained a Bachelor of Science in **** from the State University of ****. **** has received her Masters of Science in **** from ****. Combined with her extensive clinical experience, **** education enables both a strong clinical and management approach to clinical research. **** will be the Clinical Trial Manager for the study. She will be managing the day-to-day clinical trial activities and be responsible for overseeing all site and CRA activity, developing case report forms and monitoring guidelines, overseeing regulatory document management for each investigational site, as well as reviewing and tracking CRA activities which include the scheduling of site visits, site visit reports, monitoring logs, and follow-up correspondence. **** has joined Omnicare in ****, bringing with her a wealth of experience in the pharmaceutical and CRO industry where she has held various positions of increasing responsibility. Her long track record of almost 20 studies includes projects from phase I to phase IV, and therapeutic areas such as cardiovascular diseases, endocrinology, neurology, and **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. respiratory disorders. She also has gained experience in oncology projects and has monitored a dermatology trial. **** is a registered nurse and has been involved in various trials as a nurse, which makes her especially qualified due to her knowledge of both the CRO and site staff side of the project.. As the Data Management Lead, **** will be based in the UK and coordinate all clinical data management activities from there. She will be supported by a Clinical Data Analyst on the study. **** has been with Omnicare for over **** years and has gained experience in a data management role since ****. Her previous therapeutic area experience includes a dermatology project in sun bxxxx, and oncology studies in lung cancer, breast cancer, and skin malignancies. **** will manage and coordinate all internal functional technical service activities, and also be available as a primary point of contact regarding brostatistics issues for Sponsor. He will be an integral member of the project management team within Omnicare and will ensure that consistent information is relayed between Sponsor and the Biometrics team in Australia and the US. **** is based in Sydney and will be available to discuss or provide immediate assistance on issues arising in relation to Statistics, and will also be available to attend teleconferences with Sponsor. **** has been working in the healthcare industry for eight years, and has held statistician and data management roles for the same period. Most notably, **** has worked in the CRO industry since 2001 both in the UK as well as Australia. He brings advanced skills in the data management and statistical analyses of clinical trials from study set-up to database close and reporting of results. **** is experienced in database design, build and management, data validation, medical coding, query resolution, statistical analyses and study design. He has been involved in planning; coordinating and execution of clinical data solutions for many local and global studies. **** is experienced in various database software packages including SAS and Oracle Clinical used in the budgets for the studies to be conducted. He received First Class honors for a Bachelor of Applied Science (****) from the University of **** in **** and also achieved a Bachelor of Applied Science (****) from the same university in ****. As Biostatistics services will be provided from the US and Australia for this project, we propose **** as the Senior Project Statistician in the US. She will cooperate closely with ****. **** has joined Omnicare in **** as a Statistician and has been involved in over ten projects. Her therapeutic experience relevant to the planned Project includes a phase II trial in skin **** Certain confidential information contained in this document, marked with four asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 406 of the Securities Exchange Act of 19341933, as amended. malignancies and a phase III trial in malignant melanoma. **** holds an M.S. degree in **** from the University of ****, ****. **** will be the Director of Clinical Writing for this project. **** will supervise, and direct the clinical writers who will be assigned to the completion of the clinical study report is responsible for approving the final report and ensuring that the clinical writing deliverable of the study are completed in an efficient and timely fashion. Before joining Omnicare CR, **** was a member of the research faculty in the **** and **** at another CRO involving oversight of the data management, biostatistics, and scientific writing departments. **** is a graduate of both the University of **** (B. S. ****) and **** University (M.S., ****, Ph.D., ****). He has a ****, and earned a **** degree from the University of ****.
Appears in 1 contract
