Management Information Systems Manager

Job Description

Job Overview:

We are seeking an experienced and proactive TMF/CTMS Manager to lead the optimization and management of our electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). This individual will play a key role in ensuring compliance with regulatory requirements, enhancing Sponsor oversight, and driving the adoption of risk-based monitoring strategies. The ideal candidate will have strong experience in CTMS rollouts at a Sponsor organization and a deep understanding of clinical trial operations.

Key Responsibilities and Duties:

• Lead the administration, maintenance, and optimization of Veeva eTMF and CTMS to support clinical trial execution and oversight.
• Develop and implement strategies to ensure compliance with ICH E6(R3) guidance, including risk-based approaches for Sponsor oversight and monitoring.
• Collaborate with internal stakeholders (Clinical Operations, Regulatory Affairs, Safety, Data Science, QA, IT) to enhance eTMF and CTMS usability, ensuring efficient documentation and trial management.
• Act as the Subject Matter Expert (SME) for eTMF/CTMS processes, providing training, guidance, and ongoing system support.
• Ensure proper document management, classification, indexing, and completeness in compliance with Good Clinical Practice (GCP), ALCOA principles, and regulatory requirements, and internal SOPs.
• Oversee inspection readiness activities, ensuring contemporaneous audit and regulatory inspection preparedness.
• Drive continuous improvement initiatives to enhance system functionality, compliance, and efficiency.
• Monitor key performance indicators (KPIs) and Critical to Quality Factors (CtF) for TMF health and data integrity in the CTMS.
• Collaborate with external CROs and vendors to align eTMF/CTMS practices with industry standards and Sponsor expectations.
• Lead cross-functional initiatives related to TMF/CTMS upgrades, migrations, or system integrations.

Qualifications:

• Bachelor’s degree in Life Sciences, Clinical Research, Regulatory Affairs, or a related field.
• Minimum 5+ years of experience in clinical trial documentation and management within a Sponsor, Biotech, or Pharmaceutical company or CRO.
• Strong expertise in Veeva eTMF and CTMS implementation/management.
• Experience with CTMS rollouts and enhancements at a Sponsor company.
• Comprehensive knowledge of ICH-GCP, FDA, EMA, MHRA, and other global regulatory requirements for clinical trials.
• Experience preparing for regulatory inspections and audits related to TMF/CTMS.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication, stakeholder management, and training abilities.
• Ability to work independently and collaboratively in a fast-paced, dynamic biotech environment.

Preferred Qualifications:

• Experience with risk-based monitoring (RBM) and oversight models for clinical trials.
• Knowledge of AI-driven automation and digital transformation for eTMF/CTMS.
• Certification in Veeva Vault or related eClinical systems is a plus.