George Higginson is currently searching for a highly experienced Senior Clinical Data Manager for the up-and-coming CRO, specialising in Oncology.
The Senior Clinical Data Manager is responsible for the oversight and management of data management activities to ensure high quality data collection tools, database design and oversight of data management activities of our sponsored clinical trials
They’re interested in bringing in top-tier Data Managers that have a desire to progress within their career. With this role being based on-site x3 days p / w in Cambridge, Massachusetts, you get the opportunity to work alongside some of the most experienced professionals in the region.
Main Responsibilities :
- Contribute to the selection and development of data collection tools for phase I-III studies, including EDC, eCOA and eDiary tools.
- Oversight and review of vendor data management activities, with accountability for study level timeliness and quality of statistical deliveries
- Provide technical expertise for the development of data management and other clinical trial documents (Data Management Plans and associated documents, Centralized Monitoring Plans)
- Act as key contact for data management vendors to ensure effective communication between ourselves and the data management vendors.
- Effective and close collaboration with the other members of the clinical team, including medical directors, clinical operations, biostatistics and programming
- Provide internal data review to identify data issues using a range of data checks and visualisations.
- Ensure essential documents are filed allowing the reconstruction of each trial are generated, filed and maintained.
- Maintain awareness of, and ensure compliance with, our policies and procedures relating to quality standards within the Company.
Requirements :
- Bachelor’s degree in a related field & 5 years of relevant experience required; at least 3 years experience in clinical data management in a clinical research setting also required.
- 2 years of experience in leading project teams required.
- Certifications and / or courses completed in Medidata Rave Study Design and Build Essentials strongly preferred.
- Overall understanding of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
- Skilled in use of computer technology, including clinical trial databases and applications (g., IBM Clinical Development, Medidata RaveX) and ability to learn new applications
- Detailed understanding of project planning and management methods.
- Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
- Ability to work in different projects with different priorities and act as team mentor and provide data management expertise.
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