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Senior Clinical Data Manager

Radiant Systems, Inc. • Pleasanton, CA

Posted 2 months ago

Job Snapshot

Contractor
Travel - None
Experience - 0 to 99 years
Degree - None
Biotechnology
Biotech

Job Description

Please let us know your interest..

Job Title: Senior Clinical Data Manager

Duration: 6 months

Location: 4300 Hacienda Drive, Pleasanton, CA

Duties

Functions as Lead Data Manager for assigned projects, acting as the primary point of contact for clinical data management issues for assigned components.

Uses knowledge of clinical data management to define data flow for assigned projects. Identifies and implements updates to study-specific processes as needed.

Creates or oversees creation of data management documentation for assigned projects, including the Case Report Form (CRF), Data Management Plan (DMP), and clinical database specifications. Maintains robust documentation to ensure and/or document regulatory compliance at all times. Identifies and implements updates to documentation as needed.

Uses knowledge of database management to define clinical database requirements. Performs user acceptance testing of clinical database and edit checks.

Provides study-specific data entry training to data entry staff. Oversees data entry staff to ensure data quality.

Performs clinical study data review as required by the DMP. Identifies incomplete, erroneous, and/or discrepant data and uses discretion to resolve issues. Identifies and manages data trends.

Manages data discrepancy process to ensure discrepancies are generated and resolved in a satisfactory and timely manner as part of the study team. Uses professional judgment to escalate issues appropriately.

Updates clinical database based on queries, data clarification forms, discrepancy management guidelines, and performs other database changes as necessary for a study.

Maintains proficiency in use and analysis of clinical database system(s) and overall awareness of clinical data management practices.

Mentors junior data management staff and assigns project-specific tasks.

Develops, recommends, and implements operating budgets. Monitors and addresses budget variances and productivity on an ongoing basis, and assures projects operate efficiently and cost effectively.

Performs other duties as assigned.

 

Job Requirements

Skills

Familiarity with regulatory and ICH-GCP guidelines applicable to data management.

Ability to work with relevant computer software, including spreadsheets, word-processing and database packages (e.g., Microsoft Excel, Word and Access).

Ability to work with clinical database software (e.g., Medrio, Oracle Clinical, RAVE, Inform, etc.).

Ability to collaborate across departments and interact with various levels in the organization.  A working knowledge of the cross-functional areas relevant to clinical study teams.

Comprehensive understanding of the clinical study process.

Excellent communication and interpersonal skills.

Ability to work under time pressure while maintaining high standards of precision and data quality.

 

Minimum: Bachelor's degree

 

Minimum:

5 years of experience in data management or a related field.

Thanks & Regards,

 

Sandeep Reddy

Recruitment Team Lead

Ph: (908)-741-4599 x 312

dsandeep@radiants.com

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