Biomedical Data Stewardship Manager

Payrate: $55.00 - $65.00/hr. Summary: We are seeking an experienced Veeva Database Manager with strong expertise in clinical data standards to join our Biomedical Data Stewardship team. This role is responsible for contributing to the design of clinical trial databases within Veeva Clinical Data Management System (CDMS), ensuring compliance with internal data collection standards and supporting high-quality data entry for clinical trials. The ideal candidate will have hands-on experience programming clinical trial databases, applying CDISC/CDASH standards, and collaborating with cross-functional teams including Clinical Operations, Biostatistics, and Regulatory Affairs. Key Responsibilities: • Consult on the design of electronic data capture (EDC) databases using Veeva CDMS. • Review current RAVE DES data collection specifications and suggest Veeva CDMS structures. • Ensure alignment to CDISC, CDASH, SDTM, and related industry standards for clinical data collection and reporting, where necessary. • Maintain and update standard libraries, forms, edit checks, and controlled terminology in line with evolving regulatory guidance. • Work closely with Biostatistics, Clinical Programming, Safety, and Data Management to ensure smooth data flow and integration across systems. • Develop and maintain documentation including standard database specifications, edit check programming guides, and controlled terminology. Qualifications: • Bachelor’s degree in Life Sciences, Computer Science, or related field; advanced degree preferred. • 5+ years of experience in Clinical Data Management, with at least 2+ years managing Veeva CDMS databases. • Strong knowledge and hands-on experience with CDISC CDASH implementation; exposure to SDTM a plus. • Proven track record of building and maintaining clinical trial databases in compliance with regulatory and industry standards. • Strong understanding of clinical trial processes, ICH-GCP, and regulatory requirements. • Excellent problem-solving, communication, and cross-functional collaboration skills. Preferred Skills: • Experience with other EDC platforms (e.g., Medidata Rave, Oracle InForm) in addition to Veeva. • Familiarity with data visualization and analytics tools (e.g., Spotfire, SAS, R). • Experience working in global teams within a pharmaceutical, biotechnology, or CRO environment. • Knowledge of data exchange standards (e.g., CDISC ODM, Define.xml). Pay Transparency: The typical base pay for this role across the U.S. is: $55.00 - $65.00/hr.  Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select.  Full-time employees are eligible to select from different benefits packages.  Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance. Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary. You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions.  Calls may be recorded. Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com. For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy #AditiConsulting #25-22960