CTMS Administrator

Candidate needs strong experience with Medidata CTMS.

Work location is Cambridge, MA. Prefer to have at onsite if not remote should be good.

CTMS Administrator

Overview

The CTMS Administrator is responsible for the effective day-to-day management and support of the Medidata CTMS platform, enabling the successful execution of clinical trials across the portfolio. This role goes beyond transactional system support, requiring a proactive and strategic approach to problem-solving, strong stakeholder engagement, and a focus on ensuring high-quality, compliant, and consistent use of the system.

Key Responsibilities

• Perform end-to-end CTMS system administrative and study set-up activities, ensuring accuracy and completeness

• Manage user access and role permissions, including periodic access reviews, ensuring compliance with regulatory, audit, and Alnylam security requirements

• Provide timely and effective user support, troubleshooting issues and ensuring minimal disruption to study execution

• Act as a strategic partner, proactively identifying system or process issues and assessing potential downstream impacts across studies, functions, and stakeholders

• Evaluate and communicate implications of issues or changes (e.g., data discrepancies, configuration updates, system defects), ensuring impacted teams are informed and aligned on mitigation actions

• Proactively escalate risks and trends, bringing a forward-thinking, solution-oriented mindset rather than a transactional support approach

• Contribute to continuous improvement of CTMS processes, identifying opportunities to enhance efficiency, data quality, and user experience

• Support the delivery of CTMS related training

• Maintain and support standard reports and dashboards, helping teams leverage CTMS data for decision-making

Skills

• Strong strategic and critical thinking skills, with the ability to assess end-to-end impacts of system changes, issues, or decisions

• Ability to connect the dots across processes, studies, and systems, anticipating downstream implications

• Proactive communicator who flags risks early and ensures appropriate stakeholder awareness and alignment

• Comfortable working in a complex, matrixed environment, balancing multiple priorities

• Strong problem-solving mindset, with a focus on root cause analysis and sustainable solutions

Requirements

• University degree (e.g. BA, BS or equivalent) preferably in life science, science, health related, or industry related discipline is preferred or demonstrable related experience in the pharmaceutical / biotechnology industry

• Experience working for a pharmaceutical company and/or CRO in a related role

• Hands-on experience with Medidata CTMS is required, including delivering user support while identifying recurring themes, recommending improvements, and helping drive more efficient and effective use of the system

• Two or more years’ experience as CTMS administrator, superuser or similar CTMS experience in support of Phase I – III execution of clinical trials

• Strong knowledge of Good Clinical Practices (Google Cloud Platform), regulations/guidelines and compliance requirements in relation to clinical systems

Best regards,
Sourabh Shukla
Technical Recruiter
Info Way Solutions LLC
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