Sr. Study Manager (Remote)

Now is the time to join... Do you have global study management experience in CRO/Pharma?

Join ICON as Sr. Study Manager/ Global Study Manager fully dedicated to one sponsor in our embedded model! #worklifebalance #diveristyandinclusion #supportiveleadership – Just some of the reasons why ICON was named of Americas the best large employers another year in a row.

In the role of a Senior Study Manager/ Global Study Manager, you are accountable for the development of realistic detailed study startup and monitoring plans, for the delivery of the study against approved plans and conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans. You will lead study risk planning process in context of site and subject. Coordinate the study/protocol training & investigator meetings and develop/provide key inputs to Clinical Trial Budget (e.g., Per Subject Costs).

What will you be doing?

• Study Management Oversight
• Lead study risk planning process in context of site and subject
• Approve the Study Startup, Study Monitoring & protocol recruitment plans
• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• Approve & oversee drug supply management – manage flow of drug supply to the sites & set up Interactive Voice Randomization System with Supply Chain Lead
• Provide quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution.
• Responsible for Study Management and oversight of all Study Management functions internally and at the CROs
• Reviews consolidated Pre-trial assessment reports
• Accountable for the development of realistic detailed study startup and monitoring plans
• Drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy
• Accountable for the delivery of the study against approved plans
• Lead and manage the tactical execution of one or more clinical studies from study startup through database release.
• Operational Study Management for one (1) or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
• Lead inspection readiness activities related to study management and site readiness
• Develop and provide key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• Work with functional lines and directly with CRO line functions to resolve or triage site level issues.
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
• Core member of the Study Team and will represent the CRO on matters of study execution.
• Lead and coordinate the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports
• Provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
• Coordinate study/protocol training & investigator meetings

What is required?

• MUST have global clinical trial/study management experience
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• MUST have 5 years’ experience as a Global Study Manager or Trial Manager.
• Travel for this role is minimal
• MUST have managed CROs
• Minimum Bachelors’ degree in related field
• Study Manager experience must be from Pharma or a CRO.

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.