Key responsibilities include oversight of outsourced data management & EDC activities by service providers, performing and coordinating internal study team data review, and delivery of fit for purpose clinical data in support of study milestones.
ESSENTIAL JOB FUNCTIONS:
Provide clear, consistent communication to Kuraâs CROs and 3rd party Vendors with respect to data management deliverables and monitor performance against communicated expectations.Coordinate internal team review and feedback during EDC builds and/or migrations and provide clear guidance to external DM and EDC build team throughout.Accountable for DM task and milestone timelinesResponsible for ensuring data quality and integrity for clinical study data collection activities.Work with clinical team to define and maintain the Kura Comprehensive Data Review Plan.Lead Kura study team in the review of clinical study data per Comprehensive Data Review Plan.Prepare and provide internal data listings and reports as required.Review protocols for data collection and management feasibility.Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).Review study budgets and provide input on data collection, cleaning, and reporting as it relates to development of vendor contractsPartner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.Responsible for tracking and documenting data management decisions.Responsible for initiating and chairing meetings associated with assigned studies and initiativesProvide support and contribute to the development of clinical trial timelines as it relates to data management activities.Manage accruals tracking and vendor payments for data management activities.Contribute to the development of departmental procedures documentation.Complete other duties as assigned by the
JOB SPECIFICATIONS:
A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field.5+ yearsâ experience in data management or relevant work in the pharmaceutical/biopharma industry.Experience in oncology strongly preferred.Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out)Significant experience providing oversight for database migrations.Experience with an NDA submission desirableStrong project management skillsStrong vendor management skills (e.g. Biomarkers, Labs, Imaging, ECG).Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations.Experience working in 1 or more EDC platforms (Rave, InForm, etc.).Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirableSolid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Excellent interpersonal skills in addition to verbal and written communication skills.Strong Excel skills, SAS experience a plusFlexibility to travel up to approximately 5% of
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