Clinical Data Manager

Artech Information System LLC; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

A workforce solutions provider is seeking a Clinical Data Manager to lead both internal and outsourced Clinical Data Management activities in Irvine, CA. The role requires at least a Bachelor's Degree and a minimum of 3 years of relevant experience in Clinical Research or related fields. Responsibilities include managing CRFs, supporting data integrity, and developing departmental procedures. This position offers a duration of 12 months with potential for extension upon performance assessment.

Qualifications

• 3+ years of relevant work experience in Clinical Research, Computer Science, Project Management or related field.

Responsibilities

• Lead internal and outsourced Clinical Data Management activities.
• Manage the definition of Case Report Form (CRF) requirements.
• Create the Data Management Plan.
• Coordinate Centralized Data Review activities.
• Ensure data integrity, quality, and consistency.
• Lead data review activities with functional groups.
• Support development of departmental Standard Operating Procedures (SOPs).
• Conduct work in compliance with relevant regulations and Allergan policies.

Education

Bachelor’s Degree

Job description

LanceSoft is a nationally certified Minority Business Enterprise (MBE) that has established itself as a pioneer in providing highly scalable, cost-effective workforce solutions to a diverse set of customers across various industries in the United States. Headquartered in Virginia, LanceSoft currently operates out of several locations in the US and Canada.

Job Description

Title: Clinical Data Manager
Location: Irvine, CA
Duration: 12 Months

Job Functions and Duties Performed:

1. Lead internal and outsourced Clinical Data Management activities in support of Clinical Research studies.
2. Manage the definition of Case Report Form (CRF) requirements.
3. Create of the Data Management Plan.
4. Coordinate the Centralized Data Review activities in support of Risk-Based Monitoring.
5. Accountable for data integrity, quality, and consistency at Database Lock.
6. Lead data review activities and engage different functional groups leading to active participation in ensuring data integrity and completeness.
7. Support development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
8. Conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures.
9. May be required to support inspection readiness activities.

Qualification and Education Requirements:

Bachelor’s Degree with at least 3 years’ relevant work experience in Clinical Research, Computer Science, Project Management or related field.