Clinical Data Manager

Clinical Data Manager

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.

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.