The Senior Clinical CTMS Manager within the Clinical Digital Solutions team is responsible for management, maintenance, and improvement of the Clinical Trial Management Systems involved in the planning, execution, oversight, and closure of clinical trials in accordance with regulations and SOPs. This position primarily supports Clinical Operations in establishing and maintaining oversight of cross-functional trial operations through optimized design and use of the CTMS environment and related system integrations, including eTMF, EDC, and other systems.

• Serves as the Clinical Digital business steward of the CTMS to securely gather, organize, and streamline trial information compiled as intended to facilitate shared accessibility and improved decision-making by the study teams, CROs and other functions involved in the execution and management of clinical trials
• Produces and disseminates instructional materials for role-based utilization of the CTMS by consumers and key stakeholders, and provides end user support to ensure successful adoption and understanding of the applications
• Partners with Clinical Operations and Clinical Data Sciences to understand key business needs and challenges, translating this knowledge to actionable business recommendations in the anticipation and determination of use cases for the CTMS application, e.g.:
  • Investigator and Organization Database
  • Issue & Risk Management
  • Oversight Activities & Performance Management
  • Milestone and Event Tracking and Cycle Times
  • Recruitment and Enrollment Metrics
  • Contractual Agreements and Payments
  • Reporting and Dashboards with Visual Analytics
• Sets up, manages and oversees the study clinical trial management systems (CTMS) including digital integrations with eTMF, EDC, and other systems as required, in accordance with SOPs, guidelines, and regulations, in a consistent manner across individual studies and at the portfolio level in alignment with the corporate digital strategy
• Works directly with the Clinical Digital Solutions Directors and liaises with IT as needed to develop business processes for data capture, cleaning, consumption, and interpretation in clinical digital systems using methods informed by industry best practices for established and emerging technologies
• Ensures that CTMS data entered manually or via system integration is reviewed via routine checks for accuracy and timeliness to facilitate reliable reporting for informed, contemporaneous decision-making by the system’s consumers and key stakeholders
• Investigates and troubleshoots as needed to mitigate any gaps, delays, conflicts, or errors identified while communicating status to appropriate parties through resolution of such issues
• Examines future state capabilities and processes with the Clinical Digital Solutions Directors and provides input to IT for of clinical digital system roadmap development efforts including impact assessments, user requirements, and testing exercises for potential configuration change requests
• Maintains timely understanding of ICH-GCP and other federal regulations and guidance, as well as internal cross-functional SOPs, with an emphasis on requirements for risk management and sponsor oversight in the conduct of clinical trials
• Participates in internal cross-functional teams and ensure that the clinical trial management system-related activities are highlighted including training, project planning and quality across the R&D portfolio
• Performs other duties and participates in projects for clinical systems as assigned with or without accommodation

Education and Experience:  Bachelor’s Degree in business or science preferred. At least 10+ years experience in trial management in a relevant regulatory pharmaceutical setting including CTMS experience for clinical trials. Demonstrated experience in developing strategic processes in the development of a compliant and effective CTMS environment. 5 plus years of cross-functional team project management experience at a Biotechnology/Pharmaceutical company or CRO in conducting Phase I - IV multinational clinical studies, with expert knowledge of clinical trial start-up and site close-out activities and deep understanding of the implications to the clinical trial management systems (CTMS) related to content utilization, controls and compliance. 5 plus years as a CTMS business owner, technical administrator, and/or content manager directing the design and execution of CTMS plans across a therapy area or portfolio of related clinical studies.

Preferred Skills/Qualifications

• Strong organizational skills with attention to detail and effective internal/external customer interface skills
• Demonstrated expertise with CTMS is required; Veeva Vault CTMS preferred. This includes the business process as well as deep understanding of the overall clinical software suite
• Technical background with SaaS solutions including system integrations to leverage multiple data sources for clinical project management use
• Leadership role (personal or of a team) in the identification, design and delivery of continuous improvement of CTMS business processses
• Experience creating status reports, including building KPIs and dashboards for use in study teams
• CAPA experience
• Able to work to high standards in a matrix environment and interact well with all levels of the company with limited direct supervision
• Mature professional with excellent interpersonal, oral and written communication skills and the ability to work effectively in a cross-functional team setting
• Broader Clinical Study Development Process, especially Clinical Operations experience
• Ability to develop constructive partnerships with internal and external colleagues and stakeholders
• Able to focus on, and adjust priorities during peak volume times with demonstrated ability to execute operationally
• Able to solve complex problems with minimal or no direction

Additional Skills/Competencies

• Skilled at utilizing Veeva Vault platform, especially eTMF, desired
• Demonstrated ability to prioritize and manage multiple projects simultaneously
• Highly self-motivated, flexible, able to follow through in a fast-paced environment, and proven ability to meet key deadlines as required
• Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
• Highly proactive, flexible, curious and resilient
• Proficient in Microsoft Applications; Word, Excel, Project, Visio and PowerPoint
• Vault Administrator Training desired