Clinical Systems Specialist I/II - Contractor

Santen•Emeryville, CA

73d

About The Position

The Clinical Systems Specialist I/II - Contractor is responsible for providing support of the Vault Clinical i.e., the electronic Trial Master File (eTMF) used for the creation, collection, quality control, management, & archival of trials documentation and the Clinical Trial Management System (CTMS) used for managing and tracking clinical operations monitoring & study management.Primary functions include participation in the development, analysis, documentation, implementation, and maintenance of business processes related to Clinical Trials Systems per Santen Procedures (SDLC) and Regulatory Requirements. This position is also responsible for the identification of systems and process issues that require resolution within the company. This position partners with different functional areas and external stakeholders to facilitate compliance, establish best practices, standardize and optimize process, and minimize business risk.

Requirements

Minimum of one (1) year of experience for CSS I and three (3) years of experience for CSS II in a biotechnology/pharmaceutical industry or other related relevant experience; BA/BS or equivalent experience preferred.
Experience with Clinical Trial Systems (Veeva Vault Clinical) and document management.
Demonstrated knowledge of regulatory requirements related to clinical trial systems and documents.
Proven ability to build and maintain effective internal and external relationships and successfully interact with various functional areas and levels.
Good written and oral communication skills.
Experience using computer applications and systems including Veeva Vault Clinical (CTMS/eTMF/SiteConnect), in-depth knowledge of Excel spreadsheets, including formulas, lookups and pivot tables.
Demonstrated experience and ability to manage multiple projects/prioritize.
Working knowledge of ICH-GCP guidelines and major Health Authority regulations.

Responsibilities

Participates in system new version releases and configuration changes/incidents, including development, testing, and validation efforts or User Acceptance Test (UAT) execution.
Performs eTMF Document quality review.
Trains end-users Site Connect and CTMS features.
Ensures that SDLC documents are created and maintained throughout the system lifecycle.
Reviews the required Santen CSV deliverables in the event of systems implementation or retirement, in collaboration with the CSV Leader and the CSV IT Specialist, e.g., Validation Plan/Report/supporting CSV documents, Retirement Plan/Report, Data Migration Plan/Report, Archive Plan/Report, and executes the system retirement and related electronic records transfer for ongoing compliant storage of eTMF contents/CTMS data subject to continued retention requirements per applicable regulations.
Maintains System Administrator access level to Vault Clinical (CTMS and eTMF/SiteConnect) system including Sandbox, Test and Production eTMF environments.
Manages CTMS region's requirements by coordinating with Clinical Operations personnel in each region, as well as supports the CTMS-RB.
Collaborates with the appropriate stakeholders to establish integration with EDC.
Participates in Vault Clinical system configuration with Validation Leader as needed, as well as the countermeasures for changes in business requirements, e.g., ICH-GCP related changes.
Supports end users during implementation or systems upgrade and as needed in analyzing or troubleshooting issues.
Ensures regulatory requirements are met with systems capabilities and participates in systems enhancement efforts.
Follows HIPAA, ICH-GCP, and Compliance Regulations.
Participates in the audits of Trial Master File as needed.
Performs other duties as necessary as assigned by management.
Reviews and confirms the results of System Periodic Review Reports, and develops corrective and preventive action (CAPA) to resolve issues identified during periodic review [CSS II]
Contributes to the System Operation Plan and related supporting process documentation including the Training Plan, User's Guide, SOP/Work Instructions, and training curriculum in accordance with system and process changes. [CSS II]
Participates in the discussions and actions for improving business requirements, e.g., revisions of Clinical System SOP/WI, User's Guide, Operation Plan, Training Plan/Materials and other supporting documents. [CSS II]