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 .
...Professional Dog Sitter A Purrfectly Flexible Opportunity! &##128062; Do you love... ...daily or for 10 hour overnight stays) OR dog walks (30, 60, or 90 minute private walks or 60... ...Traits: At least 18 years old Experience caring for dogs (professional experience...
...As a Host or Hostess, you will be responsible for greeting guests and seating them promptly, cheerfully and courteously. Duties of this position include, seating guests, answering the phone, taking, entering and packaging To-Go orders. Responsibilities Greeting, seating...
...Who we are We are Terzo Enterprises! Check us out -- We are a logistics company that focuses on the repair, refurbishment, and re-manufacturing of pallets. Why Terzo Enterprises?~ Comprehensive benefit plan ~ Positive environment, team oriented ~6 paid...
...Conservation Officer STATUS : Permanent/Full-Time, 40 hours/Non-Exempt DEPARTMENT : Conservation REPORTS TO : Chief Conservation Officer SALARY RANGE : $16.00 - $ 23.00 per hour Summary: The Conservation Officer will work and assist the Chief Conservation...
Kana Hotel Group's mission is to be one of the most admired and service quality driven hotel companies in the industry. We will accomplish our goal by creating an atmosphere of friendly employee behavior and delivering the highest quality service and value to our guests...