Clinical Systems Specialist III Contractor
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Job Location:
Emeryville, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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.
MAJOR DUTIES OF POSITION:
- 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 regions 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 Users 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 Users Guide Operation Plan Training Plan/Materials and other supporting documents. CSS II
Qualifications :
- 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.
Additional Information :
What we offer:
This contract position is expected to have a duration of 6 months with the possibility of converting to Full Time Employee.
The hourly rate for the CSS I contract position is $40 - $54 per hour depending on experience.
The hourly rate for the CSS II contract position is $55 - $70 per hour depending on experience.
Grow your career at Santen
A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of Happiness with Vision by providing eye health products and services to patients consumers and medical professionals around the world. Guided by our CORE PRINCIPLE Tenki ni sanyo suru Santen is engaged in the global research & development manufacturing and sales and marketing of pharmaceutical products in ophthalmology. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes education and treatment. At Santen we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs role requirements and individual qualifications regardless of race color ethnicity national origin/ancestry religion sexual orientation gender gender identity/ expression age disability medical condition marital status veteran status or any other characteristic protected by law.
If you require any kind of accommodation during our recruitment process please let the recruiter from our team know.
Remote Work :
No
Employment Type :
Contract
Key Skills
- Computer Science
- Active Directory
- Computer information Technology
- PowerShell
- OS
- Windows
- Database
- SCCM
- Linux
- SAN
- Troubleshoot
- Backup
- Setup
- Technical Support
- UNIX
About Company
As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now ... View more
