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Verify assigned sites meet study qualifications Monitor assigned study sites Ensure timely data submission and query resolution Respond to site questions Prepare reports Participate in calls/meetings EXPERIENCE Minimum of at least 1 year of oncology monitoring experience with hematology study experience required Strong health care related background required Excellent pla
Posted 5 days ago
Plan, manage, and execute clinical programs Create and drive study level timeline Develop and manage study budget Provide input on operational aspects of the protocol Ensure regulatory compliance and GCP compliance Oversee the TMF with periodic audits Lead vendor selection and management, including issue escalation Establish and implement Study Management plan and all ass
Posted 6 days ago
Plan, manage, and execute clinical programs Create and drive study level timeline Develop and manage study budget Provide input on operational aspects of the protocol Ensure regulatory compliance and GCP compliance Oversee the TMF with periodic audits Lead vendor selection and management, including issue escalation Establish and implement Study Management plan and all ass
Posted 6 days ago
Create and drive study level timeline Develop overall feasibility concept and enrollment plan with input from Clinical Oversight Managers (COMs) Provide input on operational aspects of the protocol Verify regulatory and GCP compliance Oversee TMF with periodic audits Assist in vendor selection and management, including issue escalation Develop/manage Study Management plan
Posted 10 days ago
Support clinical project management of assigned clinical study (studies) Help create and drive study level timeline Assist in the collection of feasibility data to develop the enrollment and any study budget issues, as assigned Verify regulatory compliance and GCP compliance Oversee TMF with periodic audits Contribute to vendor selection and management, including issue es
Posted 18 days ago
Provide support to clinical study in a designated Therapeutic Area (TA) Acts as a team member in a function that supports the delivery of the portfolio including all functions within Clinical Development Operations Ensure all study level activities that support the TA model are successfully delivered based on the requirements of the TA strategy, appropriate international
Posted 20 days ago
Build efficiencies in the Biostats department to streamline programming efforts related to safety review deliveries and QC checks Manage SAS programming QC of summary tables (efficacy, safety, demographics, disposition, and exposure) for internally produced displays and displays provided by 3rd party vendors Generate high quality subject listings and graphs to support saf
Posted 24 days ago
Plan and oversee the successful delivery of long and short term program objectives Collaborate with the project leader and team to update program driven business plans, budgets, forecasts, and report actual performance against plan Identify risks and manage those with understanding of impact for this program and others Develop, maintain, and align a program timeline, reso
Posted 24 days ago
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