Course
CT: Project Management in Clinical Trials
FPM-40656
It has become increasingly more important to use solid project management principles when managing clinical trials. This course teaches the basic skills of project management derived from PMI principles but with focus on clinical trials. Plenty of situational examples will be provided in order to maximize understanding and clarity. Topics include a brief history of the Project Management Institute (PMI), key terms and definitions, detailed review of process groups, knowledge areas and their linkage to project management process groups, multiple tools and templates that can be utilized across the knowledge areas, virtual project management, review of personality types using the DiSC model and how that knowledge can be effectively used to manage a team, as well as program, portfolio and alliance management.
Course Information
Online
3.00 units
$645.00
Course sessions
Closed
Closed
Instructor:
Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP has over 25 years of experience having served in roles of increasing responsibility on all sides of the business (academic site, sponsor, CRO, 3rd party vendor) in project management, clinical operations, operational excellence, outsourcing and other related areas. She has significant experience in multiple therapeutic areas including oncology, immunology and rare diseases. She is PMP-certified, is an ASQ-certified black belt as well as has a CCRP certification through SOCRA.
Currently she is Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative, a non-profit organization partnering with multiple drug manufacturers and academic sites to run large platform studies studying new therapies for breast cancer and other therapeutic indications. She manages multiple groups including clinical operations, monitoring, drug safety, drug management, site regulatory as well as quality. Prior to this role, she was Senior VP, Program Management, overseeing clinical trial operational aspects as well as patient advocacy for an ultrarare pediatric indication. Prior to that, she was VP, Project Delivery at Strategikon where her team ensured project management and consultative services for successful clinical trial planning, budgeting and outsourcing. She also has worked in project management and clinical operational roles at Connect Biopharma, Astex and Jazz. Prior to this she was Executive Director, Clinical Operations and Project Management at Rainier Therapeutics where she not only served as the global lead on several studies, but also led project management across all functions. Prior to Rainier Therapeutics, she was Senior Director of Clinical Outsourcing, Operational Excellence and Project Management at Dynavax where she oversaw relationships with all clinical vendors as well as led multiple infrastructure process improvement initiatives. Prior to Dynavax, she spent several years at Covance, where her most recent position was Executive Director, Alliance Management. In this role, she was responsible for overall global program and portfolio management for several pharmaceutical/biotech sponsor clients holding ultimate accountability for successful delivery of clinical trials that Covance runs for these clients. Prior to this, at the Immune Tolerance Network, UCSF, she was Senior Director, Clinical Operations where her department oversaw 30+ clinical trials in the areas of transplantation, T1 diabetes, allergy, MS, and other autoimmune disorders. Dr Sivaramakrishna also served on the board of SOCRA for several years and is on the project and program management faculty for SOCRA’s conferences. She was invited by UC San Diego Extended Studies to develop a course on project management in clinical trials which has been running since 2017.
Full Bio
Section ID:
183783
Class type:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
Policies:
Note:
Refund deadline: one week after enrollment or start date of section, whichever is later.
Schedule:
No information available at this time.
Instructor:
Radhika Sivaramakrishna, Ph.D., PMP, CSSBB, CCRP
Radhika Sivaramakrishna, Ph.D., PMP, CSSBB, CCRP
Currently she is Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative, a non-profit organization partnering with multiple drug manufacturers and academic sites to run large platform studies studying new therapies for breast cancer and other therapeutic indications. She manages multiple groups including clinical operations, monitoring, drug safety, drug management, site regulatory as well as quality. Prior to this role, she was Senior VP, Program Management, overseeing clinical trial operational aspects as well as patient advocacy for an ultrarare pediatric indication. Prior to that, she was VP, Project Delivery at Strategikon where her team ensured project management and consultative services for successful clinical trial planning, budgeting and outsourcing. She also has worked in project management and clinical operational roles at Connect Biopharma, Astex and Jazz. Prior to this she was Executive Director, Clinical Operations and Project Management at Rainier Therapeutics where she not only served as the global lead on several studies, but also led project management across all functions. Prior to Rainier Therapeutics, she was Senior Director of Clinical Outsourcing, Operational Excellence and Project Management at Dynavax where she oversaw relationships with all clinical vendors as well as led multiple infrastructure process improvement initiatives. Prior to Dynavax, she spent several years at Covance, where her most recent position was Executive Director, Alliance Management. In this role, she was responsible for overall global program and portfolio management for several pharmaceutical/biotech sponsor clients holding ultimate accountability for successful delivery of clinical trials that Covance runs for these clients. Prior to this, at the Immune Tolerance Network, UCSF, she was Senior Director, Clinical Operations where her department oversaw 30+ clinical trials in the areas of transplantation, T1 diabetes, allergy, MS, and other autoimmune disorders. Dr Sivaramakrishna also served on the board of SOCRA for several years and is on the project and program management faculty for SOCRA’s conferences. She was invited by UC San Diego Extended Studies to develop a course on project management in clinical trials which has been running since 2017.
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Add To Cart
Instructor:
Radhika Sivaramakrishna, PhD, PMP, CSSBB, CCRP has over 25 years of experience having served in roles of increasing responsibility on all sides of the business (academic site, sponsor, CRO, 3rd party vendor) in project management, clinical operations, operational excellence, outsourcing and other related areas. She has significant experience in multiple therapeutic areas including oncology, immunology and rare diseases. She is PMP-certified, is an ASQ-certified black belt as well as has a CCRP certification through SOCRA.
Currently she is Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative, a non-profit organization partnering with multiple drug manufacturers and academic sites to run large platform studies studying new therapies for breast cancer and other therapeutic indications. She manages multiple groups including clinical operations, monitoring, drug safety, drug management, site regulatory as well as quality. Prior to this role, she was Senior VP, Program Management, overseeing clinical trial operational aspects as well as patient advocacy for an ultrarare pediatric indication. Prior to that, she was VP, Project Delivery at Strategikon where her team ensured project management and consultative services for successful clinical trial planning, budgeting and outsourcing. She also has worked in project management and clinical operational roles at Connect Biopharma, Astex and Jazz. Prior to this she was Executive Director, Clinical Operations and Project Management at Rainier Therapeutics where she not only served as the global lead on several studies, but also led project management across all functions. Prior to Rainier Therapeutics, she was Senior Director of Clinical Outsourcing, Operational Excellence and Project Management at Dynavax where she oversaw relationships with all clinical vendors as well as led multiple infrastructure process improvement initiatives. Prior to Dynavax, she spent several years at Covance, where her most recent position was Executive Director, Alliance Management. In this role, she was responsible for overall global program and portfolio management for several pharmaceutical/biotech sponsor clients holding ultimate accountability for successful delivery of clinical trials that Covance runs for these clients. Prior to this, at the Immune Tolerance Network, UCSF, she was Senior Director, Clinical Operations where her department oversaw 30+ clinical trials in the areas of transplantation, T1 diabetes, allergy, MS, and other autoimmune disorders. Dr Sivaramakrishna also served on the board of SOCRA for several years and is on the project and program management faculty for SOCRA’s conferences. She was invited by UC San Diego Extended Studies to develop a course on project management in clinical trials which has been running since 2017.
Full Bio
Section ID:
185916
Class type:
Online Asynchronous.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
This course is entirely web-based and to be completed asynchronously between the published course start and end dates. Synchronous attendance is NOT required.
You will have access to your online course on the published start date OR 1 business day after your enrollment is confirmed if you enroll on or after the published start date.
Textbooks:
No textbook required.
Policies:
Note:
Refund deadline: one week after enrollment or start date of section, whichever is later.
Schedule:
No information available at this time.
Instructor:
Radhika Sivaramakrishna, Ph.D., PMP, CSSBB, CCRP
Radhika Sivaramakrishna, Ph.D., PMP, CSSBB, CCRP
Currently she is Senior VP, Clinical Operations and Compliance at Quantum Leap Healthcare Collaborative, a non-profit organization partnering with multiple drug manufacturers and academic sites to run large platform studies studying new therapies for breast cancer and other therapeutic indications. She manages multiple groups including clinical operations, monitoring, drug safety, drug management, site regulatory as well as quality. Prior to this role, she was Senior VP, Program Management, overseeing clinical trial operational aspects as well as patient advocacy for an ultrarare pediatric indication. Prior to that, she was VP, Project Delivery at Strategikon where her team ensured project management and consultative services for successful clinical trial planning, budgeting and outsourcing. She also has worked in project management and clinical operational roles at Connect Biopharma, Astex and Jazz. Prior to this she was Executive Director, Clinical Operations and Project Management at Rainier Therapeutics where she not only served as the global lead on several studies, but also led project management across all functions. Prior to Rainier Therapeutics, she was Senior Director of Clinical Outsourcing, Operational Excellence and Project Management at Dynavax where she oversaw relationships with all clinical vendors as well as led multiple infrastructure process improvement initiatives. Prior to Dynavax, she spent several years at Covance, where her most recent position was Executive Director, Alliance Management. In this role, she was responsible for overall global program and portfolio management for several pharmaceutical/biotech sponsor clients holding ultimate accountability for successful delivery of clinical trials that Covance runs for these clients. Prior to this, at the Immune Tolerance Network, UCSF, she was Senior Director, Clinical Operations where her department oversaw 30+ clinical trials in the areas of transplantation, T1 diabetes, allergy, MS, and other autoimmune disorders. Dr Sivaramakrishna also served on the board of SOCRA for several years and is on the project and program management faculty for SOCRA’s conferences. She was invited by UC San Diego Extended Studies to develop a course on project management in clinical trials which has been running since 2017.
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