Clinical Development Systems Analyst

October 18

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Catalyst Clinical Research

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Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500

Description

• As a Clinical Development Systems Analyst you are a key member of the Business Enablement Team. • Act as a Subject Matter Expert (SME)/Super User in the assigned systems utilized for efficient management and oversight of clinical trials. • Support Catalyst Clinical Systems process and procedural development, core system functions, systems configurations, system performance troubleshooting and resolution to ensure that internal members of the Catalyst team can accomplish business tasks in a correct, efficient, and timely manner. • Provide guidance and support to the Catalyst study team members and sponsor(s) on assigned systems deployed for clinical trial studies. • Function as a liaison between Catalyst Business Enablement and assigned vendor contact(s) to ensure positive user experience and seamless support. • Facilitate study configuration kick-off meetings with study-specific team members. • Provide guidance for the best suitable configuration options for applicable systems and applications. • Provide technical support. • Train study teams on assigned clinical system(s). • Research and diagnose complex application problems. • Document and analyze systems. • Support development, implementation, and maintenance of standard system configurations to ensure baseline configuration is consistent across each study. • Track standard system configuration changes via change control process. • Support implementation and maintenance of study-specific configuration for applicable clinical systems. • Maintain software systems, solve system problems, and define business needs. • Test updates to vendor hosted software applications. • When applicable, provide Level 1 support to internal teams by triaging system user access or administering user access for clinical trials and system to the Information Technology department. • Collaborate with functional groups, as applicable, on user administration to allow for consistency in the process and documentation. • Provide input on development of standards for user administration. • May support audit preparation by reviewing and verifying all trackers and systems set up. • Support department efficiency by providing input into development of procedures and processes surrounding Catalyst Clinical Systems. • Support the development and implementation of standard in-house training initiatives and support materials encompassing Catalyst Clinical Systems by contributing input to the training development process. • Support new user training of team members on Catalyst Clinical Systems. • Support Senior Project Manager/Senior, Technical Project Manager by attending user focus groups with external partners as required. • Support Senior Project Manager/Senior, Technical Project Manager by participating in the evaluation and implementation of new tools and systems used to support Catalyst Clinical operations and functions.

Requirements

• Bachelor’s degree with a technical or science major plus relevant work experience using clinical operations systems in support of Clinical Trial activities that include but not limited to: CTMS (Clinical Trials Management System), eTMF (Electronic Trial Master File), EDC (Electronic Data Capture), e-Consent (Electronic Consent), Grants Management, RTSM (Randomization and Trial Supply Management), and Safety reporting, etc . or Higher education, equivalent certifications, and applicable work experience. • Willingness to learn new tools and technology as clinical research needs change to adapt to the rapid needs of Sponsors, Patients, and internal Staff. • Minimum of 2 years of experience working in a clinical trial support/service setting. • Knowledgeable of the clinical trial process performed at a CRO, Clinical Research Center, Clinical Research institution, Pharmaceutical, or Biotech company. • Exposure to clinical systems administration, configuration, and end user management, pertaining to clinical trial operations systems including but not limited to: CTMS (Clinical Trials Management System), eTMF (Electronic Trial Master File), EDC (Electronic Data Capture), e-Consent (Electronic Consent), Grants Management and Safety reporting, etc.