Clinical Systems Associate
South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking a Clinical Systems Associate to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Systems Associate
The Clinical Systems Associate (CSA) provides the ongoing day-to-day maintenance of the clinical systems that support the business needs of the Clinical Operations Study teams. A successful CSA assists with the development, documentation and communication of UAT process and procedures. The key deliverable for this role is to ensure timely, quality conduct of clinical systems according to protocols, standard operating procedures and all applicable regulations governing the conduct of clinical trials.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Supports the Clinical Systems Leader and Sys Ops Manager to efficiently deliver effective clinical trial solutions and systems, including set-up and coordination of system startup, UAT, maintenance, enhancements, close down activities and any associated meetings
- Partners with Clinical Systems Leader, Sys Ops Manager, Protocol Execution Teams (PET) and other stakeholders to generate test case scenarios specific to customized system design
- Manages and executes UAT process for various clinical systems, including defect management and resolution
- Collaborates with gRED IT Operational Team to resolve end user requests and issues and ensures ensuring prompt resolution of system issues and provides timeline and accurate responses to end users and other stakeholders
- Identifies business needs / issues and provides technical solutions to address them
- Gathers, receives and interprets data to provide input on continuous improvement opportunities
- Monitors key performance indicators and conducts analysis to identify root causes for defects and recommend process improvements
- Provides timely, quality study metrics to study teams using a variety of tracking tools
- Reports to the gRED Clinical Operations Sys Ops Manager
Summary of Qualifications:
- Bachelor’ s degree
- 2-5 years’ experience in Biotech/Pharmaceutical industry with clinical trial experience
- Preferred experience in User Acceptance Testing
- Ability to partner with vendor resources and other stakeholders to ensure understanding of data and requirements
- Facilitate issue resolution in a timely fashion, removing roadblocks for project team to meet project objectives
- Knowledgeable with processes and principles of project management
- Knowledgeable with User Acceptance Testing (UAT) methodologies
- Knowledgeable with Clinical Operations and Information Systems such as EDC, IxRS, Investigator Payment Management, Clinical Trial Management Systems, and Clinical Supply Systems
- Proficient problem solving skills as related to software systems
- Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
- Comfortable working in a fast-paced, dynamic environment
- Highly proficient in Microsoft Excel, Microsoft Project and Microsoft Word
- Highly effective verbal & written communication skills
- Highly effective team player and interpersonal skills (globally, internally and externally)
- Strong customer focus