Position Summary: 

Data management in clinical trials is the systematic process of collecting, storing, processing, and validating data generated during clinical research. The overarching goal is to ensure the accuracy, integrity, and reliability of the data, forming a foundation for trustworthy and statistically sound results, which in turn informs regulatory approvals and medical decisions. Accurate and reliable data is crucial for assessing the safety and efficacy of investigational products. Errors can jeopardize the health and well-being of trial participants. Additionally, early detection and resolution of data issues significantly reduce the time for sponsor payments allowing COH to recognize revenue closer to real time. 

High-quality data enables reliable statistical analysis, leading to valuable insights and discoveries that contribute to advancing medical knowledge and developing new treatments. 

Under direct supervision of the Manager, the incumbent is responsible for supporting clinical trials at the top of their scope, for existing and novel oncology therapies while working in a fast-paced environment. The Senior Clinical Data Coordinator (CTDC) is responsible for coordinating and managing the ongoing collection, quality assurance, and query resolution for highly complex oncology trials. Trial responsibility will range from First in Human and Phase I to Phase IV clinical trials.  

Working in conjunction with the Clinical Coordinators (, the Senior CTDC  ensures timely and accurate data entry, reporting, and responsiveness to data queries. Assists with ongoing monitoring and quality assurance to ensure compliance with data requirements. They may assist the CSC and/or CRN with Adverse Event Collection.  

The incumbent is responsible for independently interpreting research protocols, validation of medical record reviews, ensuring timely review of medical records, and following up on error correction and discrepancies to maintain clean and accurate data.  

They will have the added responsibility of maintaining and completing all study visits and/or elements and financial triggers in the Clinical Trial Management System (CTMS) to correspond to EDC data entry which is essential for the financial management of the study.  

They will directly communicate with physicians and clinical staff to review study data and provide routine updates to the clinical research team. Senior CTDC  will be responsible at given timepoints to perform peer reviews of data entry made into CTMS and EDC systems. 

Senior CTDC  will assist the Manager in the creation of data entry guidelines and workflows and/or a data management plan depending on the type of trial. They will also assist with the training of data personnel. They will serve as point people for data related questions. They will act as a Research Data expert to ensure that the highest quality data support is carried out and provide guidance and mentorship to other members of the research team as necessary. Other duties may be assigned as needed.