Clinical CTMS Consultant
Posted Today by Arnex Solutions LLC
Negotiable
Undetermined
Remote
Remote or Massachusetts
Summary: The Clinical CTMS Specialist is responsible for the administration and optimization of the Clinical Trial Management System (CTMS) to ensure effective support for clinical trial activities. This role involves maintaining data integrity, providing user training, and collaborating with various departments to enhance system functionality. The specialist also plays a crucial role in ensuring compliance and readiness for audits. Overall, the position is pivotal in streamlining clinical operations through effective data management and system improvements.
Key Responsibilities:
- Serve as the primary administrator for the CTMS platform, managing study setup, user access, and system configurations.
- Ensure that CTMS data (e.g., site information, milestones, subject enrollment, monitoring visits, financial tracking) are accurate and up to date.
- Partner with Clinical Operations and CROs to monitor and maintain data quality and completeness.
- Support integration and data reconciliation with other clinical systems (eTMF, EDC, IXRS, Safety, etc.).
- Develop and maintain CTMS dashboards, metrics, and reports to support operational decision-making.
- Provide training and user support for CTMS users, including creation of job aids and SOPs.
- Collaborate with IT and vendors to troubleshoot system issues and manage upgrades or enhancements.
- Participate in the validation and testing of new CTMS functionalities or configurations.
- Support inspection readiness and audit activities by ensuring accurate and compliant CTMS data.
- Contribute to process improvement initiatives to streamline clinical operations workflows and increase system efficiency.
Key Skills:
- Bachelor's degree in Life Sciences, Healthcare, Information Systems, or a related field.
- 2-5 years of experience working with a Clinical Trial Management System (CTMS) within a pharmaceutical, biotech, or CRO setting.
- Experience with CTMS platforms such as Veeva Vault CTMS, Medidata CTMS, Oracle Siebel CTMS, or similar.
- Understanding of clinical trial operations and Google Cloud Platform/ICH guidelines.
- Experience supporting system validation, audits, or regulatory inspections.
- Strong attention to detail and data accuracy.
- Proficiency in Excel, reporting tools, and database management.
- Strong communication and stakeholder management skills.
- Ability to work cross-functionally with internal teams and external partners.
- Excellent problem-solving and analytical skills.
Salary (Rate): undetermined
City: undetermined
Country: undetermined
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job Title: Clinical CTMS Specialist / CTMS Manager
Department: Clinical Operations / Clinical Systems
Position Summary:
The Clinical CTMS Specialist is responsible for the administration, maintenance, and optimization of the Clinical Trial Management System (CTMS) used to plan, track, and report clinical trial activities. This role ensures that the CTMS effectively supports study execution by providing accurate, timely, and compliant data across all studies. The CTMS Specialist serves as a key liaison between Clinical Operations, Data Management, Finance, and IT to ensure system data integrity, user training, and continuous improvement.
Key Responsibilities:
- Serve as the primary administrator for the CTMS platform, managing study setup, user access, and system configurations.
- Ensure that CTMS data (e.g., site information, milestones, subject enrollment, monitoring visits, financial tracking) are accurate and up to date.
- Partner with Clinical Operations and CROs to monitor and maintain data quality and completeness.
- Support integration and data reconciliation with other clinical systems (eTMF, EDC, IXRS, Safety, etc.).
- Develop and maintain CTMS dashboards, metrics, and reports to support operational decision-making.
- Provide training and user support for CTMS users, including creation of job aids and SOPs.
- Collaborate with IT and vendors to troubleshoot system issues and manage upgrades or enhancements.
- Participate in the validation and testing of new CTMS functionalities or configurations.
- Support inspection readiness and audit activities by ensuring accurate and compliant CTMS data.
- Contribute to process improvement initiatives to streamline clinical operations workflows and increase system efficiency.
Qualifications:
Education:
- Bachelor's degree in Life Sciences, Healthcare, Information Systems, or a related field.
Experience:
- 2 5 years of experience working with a Clinical Trial Management System (CTMS) within a pharmaceutical, biotech, or CRO setting.
- Experience with CTMS platforms such as Veeva Vault CTMS, Medidata CTMS, Oracle Siebel CTMS, or similar.
- Understanding of clinical trial operations and Google Cloud Platform/ICH guidelines.
- Experience supporting system validation, audits, or regulatory inspections.
Skills:
- Strong attention to detail and data accuracy.
- Proficiency in Excel, reporting tools, and database management.
- Strong communication and stakeholder management skills.
- Ability to work cross-functionally with internal teams and external partners.
- Excellent problem-solving and analytical skills.
Preferred Qualifications:
- Experience in system implementation or migration projects.
- Knowledge of clinical system integrations (CTMS eTMF, EDC, LMS, etc.).
- Familiarity with clinical study financial management within CTMS.
- Experience generating or maintaining operational metrics and KPIs.