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Clinical System Analyst

3 months ago

India Catalyst Clinical Research Full time

The Clinical Development Systems Analyst is a key member of the Business Enablement Team. They will act as a Subject Matter Expert (SME)/Super User in the systems utilized for clinical trial management. They are responsible for supporting Catalyst Clinical Systems procedural development, systems configurations, and troubleshooting to ensure that internal members of the Catalyst team can accomplish business tasks in a correct, efficient, and timely manner.

The Clinical Development Systems Analyst will provide support to the Catalyst study team members and sponsor(s) on systems deployed for clinical trial studies. Act as a secondary liaison between Catalyst Clinical Systems and assigned vendor contact(s) to ensure a positive user experience and seamless support.


Night Shift Preferred.

Mandatory Skills required - Candidates who have worked in Clinical Development Operations as a Clinical Trials Associate or Clinical Trials Assistant having worked directly in a CTMS system (e.g., Medidata Rave, Veeva, etc.).


System Configuration:

  • Attend configuration kick-off meetings with Senior Technical Project Manager, Clinical Operations, and study-specific team members.
  • Provide input on best suitable configuration options.
  • Support implementation of study-specific configuration for the clinical systems.
  • Support development and implementation of configuration specifications by tracking configuration changes via change control process.

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 supporting 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.

N/A


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, 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:Up to 3 years of experience working in a clinical trial support/service setting. Knowledgeable of the clinical trial process performed at a CRO, Pharmaceutical, and/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, 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.