Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field
3-5 years of clinical data management experience in pharmaceutical, biotech, or CRO settings
Proficient in EDC platforms like Medidata Rave and Oracle InForm
Deep understanding of ICH-GCP, FDA regulations, and CDISC standards
Experience with data listings, query management, and coding dictionaries
Strong organizational and problem-solving skills
Effective communicator and collaborator across team functions
Responsibilities
Oversee clinical trial data integrity and quality from collection to database lock
Ensure data accuracy and compliance with regulatory and protocol requirements
Collaborate with cross-functional teams to facilitate compliant study execution
Design and review CRFs and EDC systems for complete data capture
Develop and maintain data management plans and validation specifications
Manage data cleaning processes and resolve queries with clinical sites
Conduct ongoing data reviews to identify trends or deviations
Benefits
Comprehensive health and wellness programs
Flexible work schedule and remote work options
Opportunities for professional development and continuing education
Collaborative and innovative work environment
Employee recognition programs and initiatives
Full Job Description
Responsibilities:
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
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
Requirements:
Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field
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
