Clinical Systems Administrator

Requisition Number: 1139

Position Title: Clinical Systems Administrator Early Phase

External Description:

SUMMARY:

The Clinical Systems Administrator implements and supports Worldwide Early Phase Services Clinical System applications including the integration of new technologies and service goals. The Clinical Systems Administrator manages day to day operations and maintenance of Lab Daq and leads the project plan for Clinspark, including but not limited to, planning, scheduling, and enhancing. The Clinical Systems Administrator is responsible for maintaining and configuring system features, upgrades in a validated environment, and monitoring the end-user usage of clinical systems.

 

RESPONSIBILITIES:

• Develops clinical system solutions that meet operational needs by performing clinical system evaluations, clinical system upgrades, system configuration setup, and associated documentation.

• Report design and improvement initiatives such as instrument interfaces with Clinspark, regular, controlled upgrades to ClinSpark, and any further enhancements or new modules.
• Acts as the Subject Matter expert on full use of LabDaq to enhance Central Lab and Safety Lab capabilities.
• Provides user Lab Daq assistance, such as building and modifying tests, specs, templates, and other use-managed information within Lab Daq.
• Responsible for troubleshooting for users for Lab Daq and Central Lab.

• Assists Clinical Laboratory Senior Manager in functions of LIMS necessary to satisfy the clinical laboratory requirements of study protocols including review of study protocols, set up of laboratory tests/panels, subject selections/transfers.
• Processes system change requests and testing while working within the software options/functionality/limitations, with consideration of best practice guidelines, regulatory requirements, and operational needs.
• Configures, tests, and validates interface communications between the clinical systems and equipment or other clinical systems.

• Provides functional advice/technical expertise related to clinical systems and central lab projects.
• Troubleshoots and evaluates reported or recognized problems following Worldwide CAPA processes for any Major or Critical issues.
• Informs and advises management about any system functionality issues that will impact clinical study data or system operations.
• Develops and/or assists in developing system-related SOP and system user documents and training guides; ensure that back up procedures are defined and implemented.
• Provides and assists in training and guidance to users and end-users of the clinical systems and inter-related systems. Lead driver for Central Lab initiative.
• Proactively assist in the maintenance and improvement of above systems and procedures so that the clinic and lab functions as effectively and efficiently as possible
• Assists Lab Manager in the compliance of LabDaq to ensure that the system is compliant with GXP, ClIA and any other applicable accrediting agency
• Troubleshoots errors with the LIS reported by safety lab staff. 

• Test vendor software releases and upgrades prior to implementation to fully identify problems before going live.
• Assists with resolving clinical data queries
• Co-lead central lab implementation to ensure operational efficiency and functionality.
• Maintain the day to day operations and maintenance of LabDaq and Clinspark regarding ongoing Central Lab service and in-house safety lab.
• Performs other duties as assigned.

OTHER SKILLS AND ABILITIES:

• Knowledge of clinical systems, operational procedures, and clinical data outputs
• Knowledge of computer system integration in a clinical and validated environment.
• Command of written and verbal communication, and organizational, interpersonal, and computer skills.
• Decision making, analytical, and problem-solving skills.
• Strong organizational and planning skills
• Ability to thrive in a matrix of departments with various stakeholders. 
• Professionalism and customer service will be of the utmost importance as a representative of Worldwide.
• Strong customer (internal) focus and the ability to communicate effectively with both end-users and system developers. 
• Proactive, flexible and able to work in a fast-paced environment
• Ability to develop relationships and work effectively with internal and external stakeholders, including but not limited to, CDM and clinical lab team, PI’s, LabDaq, and client needs.
• Ability to be on call to respond to information issues and emergencies.

REQUIREMENTS

• Bachelor’s degree in Computer Sciences, Biological sciences or a related discipline or appropriate IT certification
• Minimum of 3-5 years of experience in information system and/or a laboratory setting related to information systems
• Basic knowledge of databases and SQL queries required

  PREFERRED:

• LIMS & Lab Daq administrator experience
• Experience with health care/EMR database such as ClinSpark or other clinical research resources
• Previous work in a regulated industry
• Previous experience with system implementation and validation
• Knowledge of HL7

City:

State: Texas

Employment Type: Regular

Community / Marketing Title: Clinical Systems Administrator

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: San Antonio, Texas US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.