Logo for K3-Innovations, Inc.

Clinical Data Management

K3-Innovations, Inc.

Role overview

Responsibilities

  • Manage end-to-end delivery of data management services for assigned projects/studies
  • Collaborate with CROs and other vendors to ensure high quality deliverables
  • Establish Data Management strategy at the project and/or study level
  • Provide oversight for Data Management CRO and other third party vendors

Key facts

Hard skills

Data Management Project Management Risk Management Clinical Practices Strategy Execution

Other skills

  • Collaboration
  • Leadership

About the company

K3-Innovations, Inc. logo

K3-Innovations, Inc.

At K3-Innovations, we are passionate about delivering exceptional clinical research services to the bio/pharmaceutical and medical device industries. Our highly skilled teams have a proven track record of supporting global clinical trials of all phases and across diverse therapeutic areas for companies of all sizes in the US and around the world. Our commitment is to provide our clients with the highest quality, cost-effective, and timely solutions.We offer a range of services, including:Biostatistics and Programming (submission-ready statistical analysis)SDTM Implementation (compliant with CDISC database, datasets, and documents)Functional Service Provider (FSP)Consulting ServicesStaffing ServicesAt K3-Innovations, we believe in operating with the utmost integrity and compliance. Our services and systems are governed by well-defined SOPs and policies, and are fully compliant with regulatory requirements such as ICH/GCP, FDA 21 CFR Part 11, and other client-specific standards. This ensures the validity and reliability of study data and programs for statistical outputs.Our mission is to always strive for your satisfaction. We are dedicated to finding the most efficient and cost-effective path to meet your needs, and always act in the best interests of our clients, employees, and communities. Our talented team operates as an extension of your own, providing quick engagement and strategic thinking to bring additional input, insight, and efficiency to every solution.

Company details

Company size51 - 200

Links

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Job description

This is a remote position.

Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards. Leadership, Direction, and Strategy: Establishes Data Management strategy at the project and/or study level for a smaller number of projects/studies with less complexity. Proactively identifies and manages risks at the project and/or study level for a smaller number of projects/studies with less complexity. Project Management: Plans and directs the conduct of Data Management activities for assigned projects/studies through outsourcing (e.g., study startup, study conduct, study closeout, and reporting). Provides oversight for Data Management CRO and other third party vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines. Ensures Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable Daiichi Sankyo and regulatory requirements. 

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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