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Clinical Data Manager (Contractor)

TRACON Pharmaceuticals, Inc.

Location:
San Diego, CA
Posted Date:
7/11/2014
Position Type:
Contract, Full time
Job Code:
Clinical Data Mgr (Contractor)
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Data Management,

Job Description

Position Title: Clinical Data Manager (Contractor)
Reports to: Director Data Management & IT
Department: Clinical Operations

General Summary:
The Clinical Data Manager is responsible for all data management tasks for multiple clinical studies from set up in electronic data management system (EDC) to database lock. Other responsibilities include:

Principal Duties and Responsibilities:
• Review data and generate queries according to the data validation plan (DVP)
• Maintain documentation relating to clinical data management including maintaining the data management portion of the Trial Master File
• Contribute to DVP writing
• Interface with site personnel, monitors and clinical operations staff to provide support related to data management (including EDC system issue resolution)
• Assist in streamlining clinical data management procedures to create effective practices
• Set up studies in EDC system
• Train monitors and site personnel on EDC system
• Import/export data and report generation from EDC system
• Contribute to development of reports and plans (i.e.: clinical study reports/statistical analysis plans)
• Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
• Correspond with and oversee data management vendors
• Perform tasks according to company standard operating procedures (SOPs)

Requirements

Qualifications:
Education
• Bachelor’s degree or equivalent experience

Experience/Skills
• Minimum of three years of direct clinical data management experience in the biotechnology or pharmaceutical industry
• Working knowledge of Good Clinical Practices and ICH guidelines related to CDM
• Exceptional organizational skills, highly adaptive in the face of changing priorities and practices
• Effective written communication skills

Position Requirements:
• May require limited travel for training purposes
Rate commensurate with experience and qualifications

NOTE: This description is not intended to be all inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job which may include other duties as assumed or assigned.

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