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

Navarro Inc.

Quality Assurance Engineer 4 #3186 (3805) Job at Navarro Inc.

...Navarro Research and Engineering is recruiting a Quality Assurance Engineer 4#3186 (3805) in Los Alamos, NM. Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions...

Coating Concepts

Customer Service Representative Remote | Full Time Or Part Time | No Experience Required Job at Coating Concepts

We are looking to hire a Customer Service Representative to join our team. You will take responsibility for A Customer Service Representative (CSR) acts as the primary point of contact, providing support, information, and issue resolution to customers via phone, email...

California Care Services

Physical Therapy Assistant Job at California Care Services

QualificationsCandidate must be a graduate of an accredited physical therapy assistant program with either an Associate's Degree in science or... ...a licensed driver with auto insurance proof.Job requires travel to patient's homes within 25 miles. Any excess distance is...

IB3 Global Solutions

Training Coordinator Job at IB3 Global Solutions

...capacity, yet focused on the markets we serve; and focused on the employees who make it all possible. POSITION SUMMARY The Training Coordinator provides administrative, office, learning management system (LMS) support to the department manager and to their assigned...

Tris Pharma

Pharma/Healthcare Sales Rep Job at Tris Pharma

Tris Pharma, Inc. ( is a leading privately-owned US biopharmaceutical company focusing on development and commercialization of innovative medicines addressing unmet patient needs. We have over 150 US and International patents - including applications - and several marketed...

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

R0xVTlZMdkRaR29YdkcyK0E3RFZmWEg4