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

Merck & Co.

Senior Principal Scientist (Senior Director), Discovery and Translational Immunology Job at Merck & Co.

...(Include Requirements For Education, Experience And Skills)Our Company's Discovery Immunology groups are developing a world class pipeline to treat immune mediated diseases across Gastroenterology, Rheumatology and Dermatology. We are seeking an exceptional scientific...

Catholic Schools in the Archdiocese of New York

High School Biology/Non-Regents Chemistry Teacher Job at Catholic Schools in the Archdiocese of New York

...Position: High School Biology / Non-Regents Chemistry Teacher Moore Catholic High School is seeking a dedicated and engaging educator to teach Biology and Non-Regents Chemistry at the high school level. The ideal candidate will foster a dynamic, student-centered classroom...

Akaasa Technologies

Mainframe Developers Job at Akaasa Technologies

...- MUST have moderbization experience Role Summary This role focuses on the ongoing maintenance and support of core mainframe applications. You will be responsible for managing complex legacy logic, researching system behaviors, and ensuring the stability...

GreatAuPair LLC

Personal Assistant Job at GreatAuPair LLC

I am making video reviews of coffee shops/ restaurants/hotels in Medellin. And later, I hope to expand to go to countries near to Columbia.

CV Organization

Upcoming and Recent College Graduates - work from home (code 514) Job at CV Organization

...Launch Your Career: New Graduate Opportunities Just Finished School? Start Here. Whether you're completing your final semester or already have a diploma in hand, Globe Life offers a unique entry point into a dynamic career. We're expanding throughout California...

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

SGJHMG51K3dPa09Ha05QZ3R0NklYU09YWXc9PQ==