Advanced Clinical
Senior Lead Clinical Data Manager
Advanced Clinical, Deerfield, Illinois, United States, 60063
The
Senior Lead Data Manager ("Lead")
will have experience in all required areas of a Lead Data Manager. The Lead is responsible for the data management project oversight resulting in quality and accuracy of the database for a clinical study. The Lead is the primary data management contact for the project and may also coordinate the work across multiple projects for a client program.
ESSENTIAL FUNCTIONS:
Exceed expectations and responsibilities of a Lead Data ManagerServe as primary point of contact for data management projectsMay serve as Biometrics lead for stand-alone studies including data management and biostatistics servicesCoordinate and ensure the accuracy and completeness of activities for data management assigned study team membersCreate material and present at study kick-off meetings, investigator meetings, client meetings, etc.Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check SpecificationsPerform/provide oversight of user acceptance testing for assigned projectsCreate and maintain project timelinesPrepare data transfer agreements & coordinate the receipt of data transfersAuthor all database lock documentation for assigned projectsPrepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.Responsible for project budget oversight, revenue recognition, forecasting and billing/invoicing review/approvalServe as subject matter expertProvide training and mentoring for other Leads and Clinical Data AssociatesProactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needsStandard Operating Procedures (SOPs)
Strong understanding of departmental and company procedures; ability to guide others on proceduresParticipate in the development and revision of department SOPs
Business Development
May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
Additional Responsibilities
Perform other duties as requested by managementParticipate in data management candidate interviews
QUALIFICATIONS:
Minimum of 5 years direct data management experience in pharmaceutical development or CRO environmentBachelor's Degree preferred. Work experience may be substituted for degreeWorking knowledge of CDASH standardsExcellent oral and written communication skills, organizational skills, and attention to detail are required
#J-18808-Ljbffr
Senior Lead Data Manager ("Lead")
will have experience in all required areas of a Lead Data Manager. The Lead is responsible for the data management project oversight resulting in quality and accuracy of the database for a clinical study. The Lead is the primary data management contact for the project and may also coordinate the work across multiple projects for a client program.
ESSENTIAL FUNCTIONS:
Exceed expectations and responsibilities of a Lead Data ManagerServe as primary point of contact for data management projectsMay serve as Biometrics lead for stand-alone studies including data management and biostatistics servicesCoordinate and ensure the accuracy and completeness of activities for data management assigned study team membersCreate material and present at study kick-off meetings, investigator meetings, client meetings, etc.Author and maintain all project start-up documents; including, but not limited to: eCRFs, eCRF Completion Guidelines, Data Management Plan, Edit Check SpecificationsPerform/provide oversight of user acceptance testing for assigned projectsCreate and maintain project timelinesPrepare data transfer agreements & coordinate the receipt of data transfersAuthor all database lock documentation for assigned projectsPrepare all data cleaning and data status documentation; including, but not limited to: metric reports, custom reports, data review listings, reconciliation reports, clean patient tracker, etc.Responsible for project budget oversight, revenue recognition, forecasting and billing/invoicing review/approvalServe as subject matter expertProvide training and mentoring for other Leads and Clinical Data AssociatesProactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needsStandard Operating Procedures (SOPs)
Strong understanding of departmental and company procedures; ability to guide others on proceduresParticipate in the development and revision of department SOPs
Business Development
May support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.
Additional Responsibilities
Perform other duties as requested by managementParticipate in data management candidate interviews
QUALIFICATIONS:
Minimum of 5 years direct data management experience in pharmaceutical development or CRO environmentBachelor's Degree preferred. Work experience may be substituted for degreeWorking knowledge of CDASH standardsExcellent oral and written communication skills, organizational skills, and attention to detail are required
#J-18808-Ljbffr