Clinical System Analyst III

Intuitive•Sunnyvale, CA

12d

About The Position

Primary Function of the Position The candidate will manage design, develop, implement, validate, maintain, and/or support clinical systems used by Clinical Affairs team. The candidate will have an understanding of system design, development, implementation, validation and administration processes for Clinical systems. Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager) Understand Clinical systems (pertaining to CTMS and eTMF) which includes design, creation and lifecycle management of data collection, validation, reporting specification and usage guidelines. Understand CRF/study design and interpret protocol requirements to efficiently manage the system. Create project specifications from stakeholders. Configure system for a new/existing study using existing templates and/or project specifications. Create validation of system at a study level including developing custom study requirements, test scripts, and UAT documentation. Execute User acceptance testing for assign project in the system. Administration of existing systems for multiple studies simultaneously. Provide system support for study operations and analysis groups with standard and custom reports. Training users on systems. Includes creation of training documentation and running training sessions for end users. Data cleaning and review of reported data in a system. Including compliance review, trend review, user access review. Manage post-go live issues and requests for the system. Managing activities for multiple studies simultaneously in a dynamic environment. Contribute to development and/or maintenance of departmental operating procedures for system group. Proactive in understanding company needs/objectives and able to independently seek solutions. Works on significant and unique issues in critical situations and able to provide solutions proactively.

Requirements

Minimum of 2-5 years of experience with a clinical system with a proven track record working in a medical device/pharmaceutical industry.
CTMS system(s) experience
Knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
BS/BA in a scientific or medical field

Nice To Haves

Desired to have experience with CTMS and eTMF tool both.
Desired to have medical knowledge as pertaining to medical devices for surgery.
Desired to have system knowledge as pertaining to development and validation of software
Excellent Interpersonal skills
Work well in a team environment.
Work independently to carry out tasks with minimal guidance.
Effective written communication and interpersonal skills.

Responsibilities

Understand Clinical systems (pertaining to CTMS and eTMF) which includes design, creation and lifecycle management of data collection, validation, reporting specification and usage guidelines.
Understand CRF/study design and interpret protocol requirements to efficiently manage the system.
Create project specifications from stakeholders.
Configure system for a new/existing study using existing templates and/or project specifications.
Create validation of system at a study level including developing custom study requirements, test scripts, and UAT documentation.
Execute User acceptance testing for assign project in the system.
Administration of existing systems for multiple studies simultaneously.
Provide system support for study operations and analysis groups with standard and custom reports.
Training users on systems. Includes creation of training documentation and running training sessions for end users.
Data cleaning and review of reported data in a system. Including compliance review, trend review, user access review.
Manage post-go live issues and requests for the system.
Managing activities for multiple studies simultaneously in a dynamic environment.
Contribute to development and/or maintenance of departmental operating procedures for system group.
Proactive in understanding company needs/objectives and able to independently seek solutions.
Works on significant and unique issues in critical situations and able to provide solutions proactively.