Global Study Manager

Global Study Manager - Oncology and/or Multi TA

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 Do:

You will manage day-to-day project and program management activities, supporting your team to deliver quality outcomes.

Key responsibilities include:

• Responsible to form, oversee and lead the operational sub team and request resources as needed

• Accountable for the development of realistic detailed study startup and/or study management strategy and monitoring plans, including Sourcing Strategy, input into Requests for Proposals, and for the selection of vendors

• Accountable for ensuring country-level feasibility is completed in collaboration with cross functional GSSO colleagues and Operational Analytics & Quantitative Sciences (OAQS) organization and pCRO (as applicable) reviewing Pre-trial Assessment outputs, approving sites, and assessing site activation plans

• Accountable and responsible to ensure PTMF setup for Study management and Country/Site level documents

•  Inputs into the IQMP risk planning process for the study

• Coordinates development of study/protocol training & global investigator meetings. 

• Accountable to ensure local Investigator meetings are coordinated by the Study Operational Manager (if assigned to study) and as applicable

• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)

• Accountable to ensure Study Operational Managers are inputting into the budget for local/country level tasks (if assigned).  The Global Study Manager will ensure cost variance, invoices, POs, etc. are reviewed in a timely manner ensuring spend is appropriate and on track with the forecast.

• Responsible for monitoring the budget and contracts for assigned vendors (e.g., central labs, ePRO, radiology, pCRO, etc.).

• Accountable for the delivery of the study against approved plans

• Leads inspection readiness activities related to study management and site readiness

• Support development and delivery of decentralized capabilities at investigator sites 

• The Global Study Manager if assigned to study post database lock will ensure timely study closure and release of internal and external resources as appropriate.

• Development, review or approval of the Study Startup, Study Monitoring & protocol recruitment plans and others (e.g., CRF Guidelines, IMPALA manual, Training Plan, etc.) The Global Study Manager can delegate development of plans or components of plans to Study Operational  Managers (if assigned) or CSTAs as appropriate.

• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Randomization Systems with Supply Chain Lead

• Accountable to ensure overall vendor oversight for vendors managed by Study Operational Managers (if assigned), action escalations related to vendor issues and escalate further as necessary

• Reviews consolidated Pre-trial Assessment reports, feasibility outputs, etc. in partnership with appropriate cross functional colleagues

• May support study level submission readiness

• May participate in vendor UAT and system set-up requirements review and approval (e.g., IRT, Central Lab)

• Responsible to ensure applicable system closure at study completion

• Leads and oversees all elements of study startup and monitoring functions to ensure delivery & compliance with all applicable Standard Operating Procedures (SOPs) and Quality Standards, interfacing directly with CRO Feasibility / Study Startup, Monitoring / Management & Site Contracting Groups

• Works proactively with data management functions and GSSO colleagues to ensure alignment on data flow and timely delivery.  Regular review of data reports and dashboards to identify risks and drive appropriate actions.

• Shares and escalates plan deviations to Clinical Study Team Lead (and study team) and drives/oversees mitigations

• Review vendor expenses and WO as per study budget for assigned vendors (e.g., central labs, ePRO, radiology, pCRO etc.).

• Provides ongoing assessment of subject enrollment/discontinuations to inform accurate forecasting for financial planning

• Provides operational input into protocol design

• Leads Protocol Deviation trend review partnering with Clinical

• May lead and facilitates the routine study management vendor calls

• The Global Study Manager will be the technical expert for study management systems and processes

• The Global Study Manager will champion the implementation and use of harmonized, consistent processes, and excellence in Study Management deliverables related to cost-effective, timely, and high-quality clinical trial data according to agreed global goals.

• The Global Study Manager will be responsible for the technical oversight of the operational sub team to include but is not limited to standards, continuous improvement, issue escalation/resolution, inspection readiness/quality assurance, performance feedback, review of metrics.

• The Global Study Manager partners with the operational sub team and pCRO to proactively identify and resolve study operations staff performance issues.

• For project-specific audits and inspections, the Global Study Manager can serve as a resource to the study team in addition to the Study Operational Manager(s), if assigned, to facilitate the audit/inspection.

Your Profile:

Required qualifications and experience:

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology

• BA/BS 7+ years of relevant experience

• MBA/MS/ 6+ years of relevant experience

• Demonstrated clinical research experience and/or study management experience

• Demonstrated study management/leadership experience

• Demonstrated oversight of CROs/vendors

• Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend

• Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Unit/Sub Operating Unit meets its goals

• Creates an environment where innovation is standard taking appropriate risks to advance innovative processes

• Develops ideas and leads complex projects across Sub Business Unit/Sub Operating Unit

• Develops innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating Unit

• Exercises own judgment and is a resource for others.  Works independently with assignments often self-initiated

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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