Current jobs related to Clinical Study Team Lead - Burlington - ICON Plc
-
Senior Associate Study Manager
3 weeks ago
Burlington, Canada ICON Full timeA leading healthcare intelligence organization in Burlington is seeking a Senior Associate Study Manager to oversee the execution and monitoring of clinical studies. In this role, you will support study planning, manage vendor relationships, and coordinate clinical trial activities ensuring compliance with regulations. The ideal candidate will possess strong...
-
Burlington, Canada ICON Full timeA leading clinical research organization in Burlington seeks a Local Trial Manager to oversee clinical study execution. Responsibilities include managing study timelines, communicating with key stakeholders, and ensuring quality across clinical trials. The ideal candidate will have a doctorate or equivalent experience in leading trials. A competitive salary,...
-
Global Study Manager
3 weeks ago
Burlington, Canada ICON Full timeGlobal Study Manager/ Hematology/ Early Phase ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As the world’s largest provider of Functional...
-
Global Study Manager
3 weeks ago
Burlington, Canada ICON Full timeGlobal Study Manager/ Hematology/ Early Phase ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As the world’s largest provider of Functional...
-
Senior Associate Study Manager
3 weeks ago
Burlington, Canada ICON Full timeSenior Associate Study Manager ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing Work with the clinical trial management...
-
Global Study Manager
15 hours ago
Burlington, Ontario, Canada ICON plc Full timeGlobal Study Manager (hematology/oncology)ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWhat you will be doing:Contribute to the development of...
-
Global Study Director
2 weeks ago
Burlington, Canada ICON Full timeGlobal Study Director ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. What you will be doing: Lead and coordinate a cross-functional study team of...
-
Burlington, Canada ICON Full timeA global healthcare organization in Canada is looking for a Global Study Manager with a strong background in oncology and clinical trial management. The role involves overseeing study documents, managing third-party vendors, and ensuring regulatory compliance. Candidates should have at least 3 years of experience in clinical trials, preferably in...
-
Burlington, Canada ICON Full timeA global healthcare organization in Canada is looking for a Global Study Manager with a strong background in oncology and clinical trial management. The role involves overseeing study documents, managing third-party vendors, and ensuring regulatory compliance. Candidates should have at least 3 years of experience in clinical trials, preferably in...
-
Burlington, Canada ICON Full timeA global healthcare intelligence firm is seeking a Global Study Director to lead cross-functional teams in clinical trials. Ideal candidates will have at least 7 years of clinical trial experience, with a strong background in Hematology - Oncology. You will oversee study progress, manage multiple competing priorities, and ensure compliance with regulatory...
Clinical Study Team Lead
2 weeks ago
Clinical Study Team Lead (CSTL)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
As a Clinical Study Team Lead (CSTL) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.- The Clinical Study Team Lead (CSTL) is the single point of accountability for input into study design to ensure feasibility of execution, planning and delivery of clinical studies on time, within the approved budget and with quality.- The CSTL is a Clinical Development expert focused on the execution of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies)/Therapeutic Areas.- The CSTL is an experienced project manager and matrix leader accountable for leading the study team delivery of multiple complex global studies and/or programs.- The CSTL is responsible for developing clinical trial timelines and overseeing budgets for their clinical studies.- The CSTL will partner and collaborates with functional line leadership to ensure optimal resourcing of the study team.- The CSTL is responsible for proactive risk management and inspection readiness for their clinical study(ies).- The CSTL may lead the delivery of Module 2 and 5 deliverables to support market authorizations. The CSTL may work at the program level.- When working at the program level the CSTL is accountable for developing the execution strategy and managing the timelines, budgets, and quality across multiple studies in the program.
What you will be doing:
- Study Team Leadership- Leads the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets and quality targets to meet or exceed business needs- Accountable to ensure effective study team scheduling, records and communications in partnership with the CTA- Accountable for strategic planning and decision making at the study level in line with program objectives- Accountable for issue resolution- Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross
- functional study team performance and accountable for effective study team operations- Leads study team chartering and team health check process- Partners and collaborate with functional line leadership to ensure optimal resourcing of the study team- Represents the study team at appropriate medicine team and sub-team discussions- Escalates issues to Clin Ops Head when study team has been unable to resolve or adequately manage/mitigate- Quality Oversight- Drives the monitoring and remediation of quality metrics and completion of the remediation tracker- Drives functional lines to ensure inspection readiness- Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log- Maintains active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensures appropriate prioritization and management of events through to resolution- Study Metrics & Reporting- Acts as a single, authoritative source of study information and leads study level status reporting per organizational norms and expectations- Ensures systems are maintained with up to date program status, risks, and issues- Oversees operational metrics across study and partners with functional lines to manage trends- Risk Management- Leads the study team in the management and communication of risk management plans including risk assessment and mitigation strategies- Proactively identifies operational issues and leads the team in identifying options to de-risk and capitalize on opportunities- Ensures study risk planning is ongoing throughout the study- Leads the study team in proactive problem solving and risk management- Governance & Decision Points- Drives the proactive planning to navigate the team through governance and decision point milestones to support on-time delivery of study deliverable on-time to maintain development timelines- Leads preparations for and presents the study to relevant governance per organizational norms and expectations- Ensures Quality Gate timing planning, and team readiness- In some instances, the CSTL may support the following activities:
- Business Development- A member of the GPD due diligence team for business development opportunities. Partner with GPD leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category- Submissions- Leads cross functional Module 2/5 submission sub
- teams with accountability for delivery and an overall operational strategy- Develops and leads execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submi
