Department: Development Team

Job Title: Data Manager

Description:
POSITION SUMMARY:  
This position is responsible for all Data Management activities supporting ongoing clinical trials. The position is also responsible for managing CRO (Contract Research Organization) deliverables for all clinical studies conducted by the company.

RESPONSIBILITIES:

• Responsible for data management deliverables for all clinical studies to ensure timely delivery and high data quality
• Responsible for the design and development of Data Management documents, including Case Report Forms (CRFs), CRF annotations, Edit Checks and Data Management Plan, etc.
• Developing and maintaining Data Management documents standards and processes for both in-house and CRO studies
• Manages third party vendors such as CROs, EDC (Electronic Data Capture) vendors, and local/central laboratories on defined data standards, content specifications, and timelines for deliverables
• Participate in Data Management system selection, evaluation and implementation

Job Requirements:

EDUCATION/CERTIFICATIONS/LICENSES
• Bachelor Degree in natural/life sciences or related field

EXPERIENCE
• Minimum 2-6 years of clinical data management or related experience in a pharmaceutical or CRO environment
• Hands-on experience with an Electronic Data Capture system
• Hands-on study management experiences with Clintrial, Oracle Clinical, or other related Data Management document systems
• SQL or SAS programming skills desired
 
KNOWLEDGE, SKILLS, AND ABILITIES
• Excellent project management skills with the ability to multitask
• Excellent verbal and written communications skills
• Ability to work in a fast paced and team-oriented environment
• Knowledge of regulatory requirements related to clinical data management and systems
• Knowledge of the drug development process
• Good technical skills (SAS, Clintrial, Oracle, SQL preferred)• Good working knowledge of ICH, FDA, GCP, and HIPAA regulations and guidelines

Submit your resume online now