Clinical Data Manager

Clinical Data Manager

Clinical Data Manager






Position: Clinical Data Manager
Type: Full Time
Location: Exton, Pennsylvania






Department:
Clinical Data Management

Position Title:
Clinical Data Manager

Reports to Manager's Title:
Manager, Clinical Data Management

Manager's Reports to Title:
Associate Director, Clinical Data Management

Location:
Exton, Pennsylvania

FLSA Status:
Exempt

Full Time/Part Time/Contractor:
Full Time
Principal Objective(s):
Follows established standards and procedures to provide a wide range of clinical data management duties to ensure the accuracy and completeness of clinical trial data.
Major Duties and Responsibilities:
* Follows general procedures for developing, implementing and maintaining processes to assure departmental goals are met
* Utilizes independent judgment to determine appropriate methods, techniques and evaluation criteria. Provides direction to other clinical data colleagues
* Evaluate results and document findings and assists in the creation of new clinical data management projects and processes
* May supervise other clinical data associates and/or clinical data managers
* Interacts with other departments to provide and recommend solutions to clinical data issues
* Authors SOPs and Guidance documents
* Other duties as assigned
REQUIREMENTS
Experience:
* At least 6 years of clinical data management experience, showing a progression in responsibility
* At least 4 years of current experience with EDC including study start-up, conduct and close-out
* Direct supervision of DM staff
Skills:
* Advanced knowledge of data management principles
* Demonstrated knowledge of coding dictionaries, database management packages, EDC systems and GCP
* Ability to effectively motivate and direct the activities of others and effectively interface with all levels of management
* Extreme attention to detail
Education:
Bachelor's Degree in Life Sciences or related field or a similar combination of education and experience