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Kura Oncology, located in Boston, Massachusetts, focuses on offering a pivotal role in ensuring the integrity and timely delivery of clinical study data. The role is essential in managing all facets of data management and electronic data capture (EDC) processes by liaising with contract research organizations (CROs), service providers, and internal study teams. This is particularly significant in supporting the milestones of clinical studies, especially within the field of oncology.
The position entails key responsibilities such as maintaining direct communication with CROs and third-party vendors for data management deliverables, coordinating internal reviews during EDC builds or migrations, and ensuring the completion of data management tasks within set timelines. Quality assurance and internal team guidance throughout the study lifecycle also fall under the key duties, including the development of the Kura Comprehensive Data Review Plan and contributing to the review of clinical study data.
Leadership skills are imperative as the role demands direction to the study team concerning data management activities, including planning, start-up, conduct, and study close-out. Moreover, the individual is accountable for drafting and supplying essential data management documentation, ensuring these are properly filed within the Trial Management File (TMF).
Operational tasks involve reviewing protocols for data management feasibility, assessing study budgets, and providing insights on vendor contracts related to data collection and management. The role also requires efficient tracking and documentation of data management decisions, initiating and leading relevant meetings, contributing to trial timelines, managing finances for data management tasks, and developing departmental procedures.
The position demands a degree in Biology, Mathematics, Computer Science, or a related scientific field, with at least five years of applicable experience in the pharmaceutical or biopharma industries. Specialized experience in oncology, significant management of DM activities across various study stages, and a familiarity with EDC platforms are highly valued. Other desired qualifications include a solid understanding of the clinical drug development process, adherence to regulatory standards (ICH/GCP), and exceptional organization, communication, and project management abilities. Proficiency in Excel and some experience with SAS are also beneficial for this role.
The ideal candidate should demonstrate flexibility, strong vendor management skills, and bring independent expertise to study teams and vendors regarding data management. A readiness to travel up to approximately 5% is expected for fulfilling the job's requirements.
This job offer was originally published on RemoteOK
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This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.
