The Senior Clinical Data Manager (Sr. CDM) is responsible for the performance of all operational aspects of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on all such projects. The Sr. CDM will work on projects of all sizes in various indications and may lead a team of CDMs (DNAtrix employee, contract and/or vendor) on the project to ensure all the study activities are carried out according to Standard Operating Procedures. Applicants based in Texas are preferred.
Duties and Responsibilities include but are not limited to:
- Creates, reviews and finalizes case report forms (CRFs/eCRFs)
- Develops, and/or conducts comprehensive review of CRF Completion Guidelines (CCGs)
- Develops, and/or conducts comprehensive review of Data Validation Specifications (DVS)
- Oversees and participates in all User Testing of the DVS programs together with the Database Developer to resolve all findings before releasing into production
- Heads all Data Cleaning activities including data review and query generation and integration
- Assists drug safety with coding specifications of DM and PVG vendor(s)
- Assists drug safety with SAE Reconciliation and/or assistance to DM and PVG vendor(s)
- Manages external data (e.g., Central Labs, Imaging Vendors, etc.)
- Performs Database Quality Control activities
- Oversees all Database Lock activities
- Produces and provides metrics on data processing status to the Project Manager/Clinical Project Lead
Experience and Skills:
- A minimum of 4 years of directly-related clinical data management experience.
- Working knowledge 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 (e.g., Medidata) and ability to learn new applications; prior extensive experience with EDC
- Computer literacy, proficiency in MS Office including Word, Excel, PowerPoint, Outlook
- Familiarity with remote working environments; home-office established
- A BS or BA degree, preferably in life science or healthcare field
Qualified candidates should forward a resume and cover letter including a statement of interest, availability, and experience in PDF format to: careers@DNAtrix.com. PLEASE, NO PHONE CALLS.
DNAtrix is an Equal Opportunity Employer.