Clinical Systems Specialist

Location
Emeryville, CA, United States
Posted
Nov 01, 2018
Ref
o8Eq8fw4
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

We are in search of top talent to help us meet our aggressive and important goals.

PRIMARY PURPOSE OF POSITION

This position is responsible for providing support of the electronic Trial Master File (eTMF) system used for creation, collection, quality control, management, & archival of trial master file documentation and support of 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. 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:
  • Creates and maintains the documentation for Configuration Changes and Incidents.
  • Reviews and confirms the results of System Periodic Review Reports, and develops corrective and preventive action (CAPA) to resolve issues identified during periodic review.
  • Reviews and approves the required Santen CSV deliverables in the event of systems retirement in collaboration with the CSV Leader and the CSV IT Specialist, e.g., 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 content subject to continued retention requirements per applicable regulations.
  • Contributes to the System Operation Plan and related supporting process documentation including the eTMF Training Plan, Work Instructions, and training curriculum in accordance with system and process changes.
  • Maintains System Administrator access level to Vault eTMF system including Sandbox, Test and Production eTMF environments.
  • Responsible for implementing the CTMS system configuration management, incident management, and change control.
  • Prepares the CTMS system operation plan.
  • Manages CTMS region's requirements/opinions by coordinating with the Clinical Operations personnel in each region, as well as supports the CTMS-RB lead coordinator.
  • Determines and discusses the actions for improving business requirements, e.g., revision of SOP/WI/CTMS User's Guide.
  • Determines and discusses the necessity of the CTMS system configuration with VC 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 leads systems enhancement efforts.
  • Follows HIPAA, ICH-GCP, and Compliance regulations.
  • Leads and/or performs audits of Trial Master File as needed.
  • Performs other duties as necessary as assigned by management.

KNOWLEDGE AND SKILL REQUIREMENTS:
  • Minimum of two (2) years of experience in a biotechnology/pharmaceutical industry or other related relevant experience; BA/BS or equivalent experience preferred.
  • Significant experience with Clinical Trial Systems 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.
  • Excellent written and oral communication skills.
  • Experience using computer applications and systems including CTMS, Veeva eTMF, in-depth knowledge of Excel spreadsheets, including formulas, lookups and pivot tables.
  • Demonstrated experience and ability to manage multiple projects/prioritize.
  • Working knowledge of GCP and ICH guidelines and other industry regulations.

For more information about our company and the work experience, please visit www.santenusa.com