Description
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 Kura’s 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 timelines
- Responsible 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 contracts
- Partner 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 initiatives
- Provide 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+ years’ 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 desirable
- Strong project management skills
- Strong 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) desirable
- Solid 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 plus
- Flexibility to travel up to approximately 5% of
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