Sr. Clinical Trial Manager - Vaccines - Remote US/Canada
PRA Health Sciences
2021-11-03T17:10:48Z
Healthcare - Physician
(No Timezone Provided)
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
The Clinical Team Manager 3 (CTM) leads the clinical team to ensure successful delivery of clinical studies in accordance with protocol, budget, standard operating procedures, policies and applicable regulations. Ensures optimal productivity and quality to drive sponsor satisfaction and strong financial performance. Proactively identifies, resolves/mitigates and escalates risks and/or issues.
This position will have 2-3 direct reports they will be responsible for managing.
Primary Responsibilities:
Manages and prioritizes the clinical deliverables (, site selection, subject/patient recruitment/enrollment, data monitoring, etc.) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations. Maintains thorough knowledge of contract details. Escalates out-of-scope task requests for review and approval prior to execution. Creates and administers clinical and site training plans. Ensures clinical team understands responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance. Provides timely feedback to address performance issues; shares performance information with functional manager as appropriate. Collaborates with a cross functional group of site monitors, site managers, biometrics team members to achieve successful delivery of data. Ensuring timely data entry, query resolution, on and off site data review, to ensure on time quality data deliverables. Maintains detailed knowledge of study resource requirements, burn rates and plans accordingly, ensures timelines, quality standards and budget expectations are met. Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout project duration. Recognizes potential risks within the study protocol and operational aspects of the trial; serves as the primary liaison for clinical monitoring, site risks and issues; proactively establishes contingency and mitigation plans. Analyzes metrics and reports to keep abreast of performance. Leverages plans to address issues. Ensures that quality standards and applicable regulatory requirements are met. Collaborates with quality assurance department members to identify study sites requiring corrective and preventative action plans. Facilitates internal audits and local health authority inspections as needed. Oversees filing of study and site level essential documents by project team members to ensure that all initial or amended study information is submitted, approved and filed in accordance with the protocol, applicable guidelines and local regulations Communicates effectively with sponsor, project manager, functional team leads and other project team members. Selects appropriate communication platforms to convey information effectively and efficiently. Leads clinical study team meetings; presents at intra-/inter-departmental and external meetings. Creates, maintains and collaborates on applicable project documents, plans, templates and tools. Independently manages delivery of complex clinical studies, , high risk, medium to high budget, high number of sites across many regions. May be assigned as a Global clinical team manager or project lead. Collaborates with the project team in creation and execution of sponsor and cross-functional team communications, identifying issues and risks and potential solutions. Contributes to the development of less-experienced CTMs and other study team members by presenting case studies, delivering technical and soft-skill training, mentoring and coaching. Leads assigned departmental continuous improvement initiatives. Contributes to creation/ updates of training materials
Qualifications
Qualifications:
Bachelor’s degree in a health, life sciences or other relevant field of study 10 years’ relevant experience Advanced knowledge of the drug development process Advanced project management skills Excellent leadership and influencing skills High proficiency with Microsoft Office and company collaboration applications
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Sr. Clinical Trial Manager - Vaccines - Remote US/Canada
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
The Clinical Team Manager 3 (CTM) leads the clinical team to ensure successful delivery of clinical studies in accordance with protocol, budget, standard operating procedures, policies and applicable regulations. Ensures optimal productivity and quality to drive sponsor satisfaction and strong financial performance. Proactively identifies, resolves/mitigates and escalates risks and/or issues.
This position will have 2-3 direct reports they will be responsible for managing.
Primary Responsibilities:
Manages and prioritizes the clinical deliverables (, site selection, subject/patient recruitment/enrollment, data monitoring, etc.) to ensure that deliverables meet quality and regulatory requirements, project timelines, budget, and sponsor expectations. Maintains thorough knowledge of contract details. Escalates out-of-scope task requests for review and approval prior to execution. Creates and administers clinical and site training plans. Ensures clinical team understands responsibilities and performance standards. Reviews metrics and other information sources to monitor team and individual performance. Provides timely feedback to address performance issues; shares performance information with functional manager as appropriate. Collaborates with a cross functional group of site monitors, site managers, biometrics team members to achieve successful delivery of data. Ensuring timely data entry, query resolution, on and off site data review, to ensure on time quality data deliverables. Maintains detailed knowledge of study resource requirements, burn rates and plans accordingly, ensures timelines, quality standards and budget expectations are met. Forecasts according to contractually agreed units/hours, tailoring to manage fluctuation of activities throughout project duration. Recognizes potential risks within the study protocol and operational aspects of the trial; serves as the primary liaison for clinical monitoring, site risks and issues; proactively establishes contingency and mitigation plans. Analyzes metrics and reports to keep abreast of performance. Leverages plans to address issues. Ensures that quality standards and applicable regulatory requirements are met. Collaborates with quality assurance department members to identify study sites requiring corrective and preventative action plans. Facilitates internal audits and local health authority inspections as needed. Oversees filing of study and site level essential documents by project team members to ensure that all initial or amended study information is submitted, approved and filed in accordance with the protocol, applicable guidelines and local regulations Communicates effectively with sponsor, project manager, functional team leads and other project team members. Selects appropriate communication platforms to convey information effectively and efficiently. Leads clinical study team meetings; presents at intra-/inter-departmental and external meetings. Creates, maintains and collaborates on applicable project documents, plans, templates and tools. Independently manages delivery of complex clinical studies, , high risk, medium to high budget, high number of sites across many regions. May be assigned as a Global clinical team manager or project lead. Collaborates with the project team in creation and execution of sponsor and cross-functional team communications, identifying issues and risks and potential solutions. Contributes to the development of less-experienced CTMs and other study team members by presenting case studies, delivering technical and soft-skill training, mentoring and coaching. Leads assigned departmental continuous improvement initiatives. Contributes to creation/ updates of training materials
Qualifications
Qualifications:
Bachelor’s degree in a health, life sciences or other relevant field of study 10 years’ relevant experience Advanced knowledge of the drug development process Advanced project management skills Excellent leadership and influencing skills High proficiency with Microsoft Office and company collaboration applications
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.