Remote Clinical Development Systems Analyst

As a Clinical Development Systems Analyst you are a key member of the Business Enablement Team. You will act as a Subject Matter Expert (SME)/Super User in the assigned systems utilized for efficient management and oversight of clinical trials. Supporting 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.

You will 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.

Position Accountabilities/Responsibilities:

• System Configuration and System Maintenance:
• Facilitate study configuration kick-off meetings with study-specific team members (i.e., Project Director, Associate Director, Project Manager, Clinical Trial Lead, Clinical Research Associate, and Clinical Trial Associate).
• 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.
• Track study-specific configurations via change control process.
• Maintain software systems, solve system problems, and define business needs.
• Test updates to vendor hosted software applications.

User Administration:

• 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.

Other responsibilities:

• 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 (e.g., e-Learning curriculums, Ad Hoc Lunch and Learns, Desk-side checklists, etc.) 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/Responsibilities:

Education: 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.

Experience:  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.

Required Certifications: N/A

Required Skills:

•     Experience working at a CRO, Clinical Research Center, Clinical Research institution, Pharmaceutical, or Biotech company and knowledge of the research process, clinical trials operational needs, and tools. CRO/Clinical Service provider experience is preferred.

•     Technical proficiency with a working knowledge of a range of computer applications.

•     Proficient with Microsoft Office Suite.

•     Excellent written and oral communication skills.

•     Excellent presentation skills.

•     Strong organizational, problem-solving, and analytical skills.

•     Ability to manage priorities and workflow.

•     Versatility, flexibility, and a willingness to work within constantly changing priorities.

•     Proven ability to handle multiple projects and meet deadlines.

•     Strong interpersonal skills.

•     Ability to deal effectively with a diversity of individuals at all organizational levels.

•     Commitment to excellence and high standards.

•     Creative, flexible, and innovative team player.

•     Ability to work independently and as a member of various teams and committees.

•     Good judgement with the ability to make timely and sound decisions.

Working Conditions:  ​Sedentary work that primarily involves sitting/standing.​