Senior Clinical Data Manager

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:

• Lead studies as the Senior Clinical Data Manager; liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues. May also serve as support for other Lead Clinical Data Managers as needed.
• Develop and/or review case report forms (CRFs) within an EDC system and build relevant database structure.
• Develop or quality control review Data Validation Specifications (DVS) documents.
• Program edit checks and other system functions within EDC as needed.
• Facilitate or participate in User Acceptance Testing (UAT) prior to study go-live.
• Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans.
• Responsible for data cleaning activities including data review, query generation and management, and development of study metrics either through direct action or delegation to other team members. May find discrepancies, track trends, and identify areas of retraining needed from members of the study team.
• Responsible for the handling and reconciliation activities of external data (e.g., Central Labs, IVRS, etc.).
• Oversee or participate in database lock activities, including managing user access and authoring or providing quality control review of lock documentation
• Partner with other functional groups (e.g., Biostatistics, Statistical Programming, Medical Writing, Project Management, etc.) to ensure data management aspects of the project are properly considered and integrate well with the other activities.

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.

How To Apply:

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.

George Higginson

AL Solutions

[email protected]