This is a remote position.
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements. This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution.
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.
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 888-897-7781 or through their website at dhs.gov/ e-verify .
...is Tim Tebow, a professional sports bound college athlete, a 40-year-old mother trying to get fit, or a 7-year-old athlete training for the... ...one and work with anyone. We have classes for 7-11 year olds, 12-14 year olds, 15-18 year olds, and adults. We'll have one on one...
Cat in a Flat is an online platform/app that connects cat owners with local cat-loving sitters. We are always looking for great cat sitters to join our cat-loving community.Tasks Cat sitting duties with Cat in a Flat include:Daily visits either once or twice a day. Each...
...Job Description Job Description Join USMHE, Inc. as an Occupational Health Testing Technician and embrace the thrill of a career that offers over 90% travel across diverse locations! Imagine the excitement of driving to new destinations while assisting organizations...
...company is a great fit for you. Youll be an integral member of our program administration team. U.S. Care Behavioral Health - a 12 year old private-practice business whose passion is to profoundly improve the well-being and quality of life of our clients and team...
Night Concierge shifts are 4pm-11pm or 11pm-7am. BreedAbove is growing our team of passionate pet lovers. The Night Concierge will support all areas of pet services. The primary responsibility of this role is to support the dog boarding experience and ensure our service...