Clinical Data Manager

📋 Description

• • As a Clinical Data Manager at NantWorks, LLC, you will be a pivotal member of the Biometrics department, leveraging your expertise to build, maintain, and optimize clinical trial databases. This role is crucial for ensuring the integrity, accuracy, and timeliness of clinical trial data, which directly impacts the development of groundbreaking cell and immunotherapy products aimed at transforming patient lives.
• • You will be responsible for the end-to-end management of clinical data, from the initial design and configuration of Case Report Forms (CRFs) to the final database lock. This involves a deep understanding of study protocols, departmental standards, and best practices in electronic data capture (EDC) systems.
• • A key responsibility includes creating and/or reviewing study-specific CRFs, whether electronic or paper-based. You will collaborate closely with the core clinical team to incorporate their input efficiently, ensuring that CRFs accurately reflect the study design and capture all necessary data points in a timely manner.
• • You will play a central role in configuring, migrating, and rigorously testing EDC databases. This requires adherence to internal procedures, a keen eye for study-specific requirements, and the application of system best practices to ensure a robust and reliable data collection tool.
• • As the primary database manager for study-specific clinical teams, you will be tasked with compiling and implementing edit checks. These critical checks are designed to identify and flag data inconsistencies or errors early in the data collection process, thereby maintaining data quality.
• • You will also develop detailed database requirements for EDC vendors, acting as the main point of contact and study database manager. Your role will involve working closely with these vendors to ensure the timely delivery of all required data management deliverables.
• • The creation and/or review of essential study-specific data management and database documentation is another core function. This includes developing and maintaining documents such as the Data Management Plan, CRF Completion Guidelines, Coding Guidelines, Annotated CRFs, and Edit Check Specifications, ensuring comprehensive documentation for each study.
• • You will actively participate in study-specific team meetings, providing regular status reports and generating requested metrics. This includes tracking query status, identifying data trends, and communicating key data management insights to the broader clinical team.
• • Performing thorough data review and managing the entire query lifecycle – from generation to closure – is essential. This proactive approach ensures that all data discrepancies are resolved efficiently and accurately.
• • A significant aspect of the role involves the coding of verbatim terms, such as adverse events and concomitant medications, using standardized coding dictionaries. You will collaborate with medical scientists to ensure accurate and consistent coding, and then integrate these coding files into the clinical database.
• • You will be instrumental in driving process improvements within the Biometrics department. This includes participating in the development of new data management processes and revising existing ones to enhance efficiency and quality.
• • As a subject matter expert, you will train internal colleagues on clinical data management best practices, both informally and through formal training sessions. You will also be responsible for training investigators and study coordinators at investigator meetings on CRFs, the EDC system, and completion guidelines.
• • Providing expert data management support and guidance to clinical teams, grounded in data management best practices, is paramount. You will offer analytical insights into data management strategies and advise the internal team on tactical approaches.
• • For more junior team members, you will provide work direction, guidance, mentoring, and support. This includes training them in more complex clinical data management processes, fostering their professional growth.
• • Adherence to Standard Operating Procedures (SOPs), contributing to process improvements, and standardizing templates are key to maintaining consistency and quality across all studies.
• • You will also have the opportunity to engage in ad-hoc and cross-functional projects, contributing to broader business needs and gaining valuable developmental experience.
• • This role offers the chance to be part of a dynamic, commercial-stage biotechnology company at the forefront of developing innovative immunotherapies, contributing directly to the fight against cancer and infectious diseases.