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

$90,000 — $138,750/year