Clinical Data Manager

This is a remote position. Key Responsibilities Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol. Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines. Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams. Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations. Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH‑GCP). Manage database lock activities and contribute to the preparation of clinical study reports (CSRs). Serve as the primary point of contact for data management vendors and oversee their deliverables. Participate in study team meetings and provide status updates related to data quality and timelines. Support audit readiness and participate in regulatory inspections when required. Minimum Qualifications Bachelor’s degree in Life Sciences, Computer Science, Health Informatics, or related field. Advanced degree is a plus. Minimum of 3–5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment. Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap). Strong understanding of ICH‑GCP, FDA regulations, and CDISC standards. Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug). Excellent organizational, analytical, and problem‑solving skills. Strong communication and collaboration skills across cross‑functional teams. Experience working on global, multi‑site clinical trials preferred. Benefits In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well‑being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work‑life balance while providing the necessary support for professional and personal growth. E-Verify Participation Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at View phone number on click.appcast.io or through their website at dhs.gov/e-verify. Requirements 7+ years of experience in GCP auditing, clinical quality, or regulatory compliance Direct experience with FDA BIMO audits or inspections, either: As a former FDA inspector As an industry auditor supporting FDA BIMO inspections Demonstrated experience auditing clinical trials under INDs, preferably supporting NDA readiness Strong working knowledge of: FDA BIMO regulations ICH E6 (R2/R3) GCP guidelines Ability to independently lead audits and communicate findings clearly to cross‑functional teams Excellent verbal and written communication skills, including delivery of real‑time audit feedback Comfortable working in a fast‑paced, inspection‑style environment #J-18808-Ljbffr