Manager/Senior Manager, Clinical Data Sciences jobs in United States
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Kura Oncology, Inc. · 1 day ago

Manager/Senior Manager, Clinical Data Sciences

Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment. The role involves overseeing data management activities, ensuring data quality and integrity, and providing leadership throughout the study lifecycle.

BiopharmaBiotechnologyGeneticsHealth CareMedicalOncologyPrecision Medicine
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Comp. & Benefits

Responsibilities

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

Qualification

Data managementOncology experienceEDC platformsProject managementDatabase migrationsClinical drug developmentRegulatory knowledgeExcel skillsInterpersonal skillsCommunication skillsTime management

Required

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 managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out)
Significant experience providing oversight for database migrations
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.)
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

Preferred

Experience in oncology strongly preferred
Experience with an NDA submission desirable
Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirable

Benefits

Career advancement/ development opportunities
Competitive comp package
Bonus
401K + Employer contributions
Generous stock options
ESPP Plan
20 days of PTO to start
18 Holidays (Including Summer & Winter Break)
Generous Benefits Package with a variety of plans available with a substantial employer match
Paid Paternity/Maternity Leave
In-Office Catered lunches
Home Office Setup
Lifestyle Spending Stipend
Commuter Stipend (Boston Office)
Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Company

Kura Oncology, Inc.

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Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer.

Funding

Current Stage
Public Company
Total Funding
$1.24B
Key Investors
Bristol-Myers SquibbHercules CapitalEcoR1 Capital
2024-01-24Post Ipo Equity· $150M
2023-06-14Post Ipo Equity· $100M
2022-11-03Post Ipo Equity· $25M

Leadership Team

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Troy Wilson
Co-Founder, CEO and President
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Brian T. Powl
Chief Commercial Officer
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Company data provided by crunchbase