Job Description

JOB DESCRIPTION
The Clinical Data Manager II will provide comprehensive data management support for assigned clinical studies. The CDM will be responsible for performing ongoing data review to ensure accuracy, completeness, and consistency of clinical trial data in accordance with the study protocol and data management plan. The CDM will have a minimum of two years of clinical data management experience, including hands-on data review experience, and demonstrated proficiency in Medidata Rave.
RESPONSIBILITIES
Responsibilities
Clinical Data Management
Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency.
Identify, investigate, and resolve data discrepancies through query management.
Conduct manual and system-driven data reviews in accordance with study protocols and DMPs.
Collaborate with cross-functional teams (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to support data cleaning activities.
Participate in database lock activities and ensure data readiness for interim and final analyses.
Maintain study documentation in compliance with regulatory requirements and internal SOPs.
Manage and maintain user access within clinical data management systems (e.g., Medidata Rave).
Process access requests, modifications, and terminations in accordance with established procedures.
Ensure appropriate role-based access and system permissions are assigned.
Maintain audit-ready documentation related to user access activities.
Support periodic access reviews and compliance checks.
Assist with system user training and troubleshooting as needed.
User Access Management
QUALIFICATIONS
Required Qualifications
Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
Minimum of 2 years of clinical data management experience.
Demonstrated hands-on data review experience in clinical trials.
Proficiency in Medidata Rave (build knowledge a plus, but not required).
Cloud Administration module experience is preferred.
Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines).
Experience with query management and discrepancy resolution.

Job Tags

Permanent employment, Interim role

Similar Jobs

MAU Workforce Solutions

Control Room Operator Job at MAU Workforce Solutions

...industry preferred ~Prior experience in LTO roles or equivalent preferred ~Basic computer skills, including proficiency in Microsoft Office (Excel, etc.) ~Strong understanding of safety procedures and quality standards ~Ability to troubleshoot electrical and...

FedEx Corporation

Customer Service Parcel Specialist Job at FedEx Corporation

...Primary responsibility for coordination of all shipping related services and activities, include: Maintain log of all incoming and... ...and maintain established business hours in order to support the FedEx Office business; regular attendance and/or reporting could include...

Sumeru Solutions

ﾠSalesforce CRM Mobile Developer / Salesforce Mobile Solutions Developer Job at Sumeru Solutions

Salesforce CRM Mobile Developer / Salesforce Mobile Solutions Developer Role summary: We are looking for an onshore Salesforce CRM Mobile Developer to support a mobile transformation initiative that brings key CRM, analytics, and customer/sales workflows into...

Prometheus Federal Services

Healthcare Change Management Consultant Job at Prometheus Federal Services

...agencies. We are exploring the addition of an experienced Healthcare Change Management Consultant to the planning and execution of change management... ...healthcare environments Produce and support executive-level written and verbal communications, including briefings,...

Crime Scene Resources, Inc

Forensic Investigator Job at Crime Scene Resources, Inc

...read more Duties Responds to death scenes; Investigates the cause and manner of death in cases of unattended natural death... ...and Education Associate's Degree in Criminal Justice, forensic science, medicine/health care, or related field -AND- one (1)...

Clinical Data Manager II Job at Cytel - EMEA, Cambridge, MA

R0xVTlZMdkRaR29YdkcyK0E3RFZmWEg4