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.
Be part of our network of Subject Matter Experts.
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 .
Responsible for planning, creation and execution of digital marketing and advertising (including, but not limited to social media). In addition, the position is responsible for online reputation management across all channels, including hospital locations and individual...
...patient care and committed to clinical excellence. Is this you? Wanting to deliver high quality behavioral healthcare. Seeking work life balance. Interested in growing professionally. What we offer Therapists: Flexible work schedules. Full Time...
...Hamilton County. This is a great starting point for a recent Social Work or Psychology graduate and students in an MSW or Masters in... ...Management Training Academy with start dates every month! No experience is required! We are looking for BSW, Psychology, Sociology...
...including Top Companies to Work For), and were committed to continuously raising the bar. What You'll Do As Social Media / Digital Marketing Coordinator, youll lead the strategy, execution, and optimization of our marketing initiatives both internal and...
Overview The Medical Interpreter serves as a cultural and linguistic resource to both patients and providers by facilitating the successful delivery of patient care service to a linguistically diverse population. In this role the interpreter participates as a neutral...