Senior Manager

We are seeking a highly skilled Project Manager with a strong background in clinical research to lead and oversee projects related to clinical trial data management. The ideal candidate will have direct experience managing projects that utilize clinical trial technology tools such as CTMS, EDC, and ePRO. This role requires a deep understanding of clinical research processes, regulatory compliance, and the ability to ensure projects are delivered efficiently and within scope.

Key Responsibilities
- Manage and coordinate clinical trial data management projects, ensuring adherence to timelines, budgets, and quality standards.
- Oversee the implementation and utilization of clinical trial technology tools including CTMS (Clinical Trial Management System), EDC (Electronic Data Capture), and ePRO (electronic Patient-Reported Outcomes).
- Collaborate with cross-functional teams including clinical operations, data management, biostatistics, and regulatory affairs to ensure project alignment and successful delivery.
- Ensure compliance with regulatory standards such as ICH-GCP (International Council for Harmonisation - Good Clinical Practice), GxP guidelines, and 21 CFR Part 11 electronic records requirements.
- Identify project risks and develop mitigation strategies to address potential issues proactively.
- Provide regular project status updates to stakeholders and senior management, highlighting progress, challenges, and solutions.
- Facilitate communication between clinical teams and technology vendors to optimize tool performance and data integrity.
- Maintain thorough project documentation and ensure all deliverables meet quality and compliance standards.

Required Qualifications
- PMP (Project Management Professional) certification is mandatory.
- Proven experience managing clinical trial projects with direct involvement in clinical trial data management.
- Hands-on knowledge and experience working with clinical trial technology tools such as CTMS, EDC, and ePRO systems.
- Strong understanding of clinical research principles and regulatory requirements, including ICH-GCP, GxP, and Part 11 compliance.
- Excellent organizational, communication, and leadership skills to effectively manage multidisciplinary teams and complex projects.
- Ability to work in a fast-paced environment and manage multiple priorities simultaneously.

Preferred Qualifications and Benefits
While not explicitly stated, candidates with additional certifications or experience in related areas such as clinical operations, regulatory affairs, or quality assurance may have an advantage. Benefits typically include opportunities for professional growth, working with cutting-edge clinical technologies, and contributing to impactful clinical research projects.

This role offers a unique opportunity to apply project management expertise within the clinical research field, ensuring that innovative clinical trials are conducted efficiently and in full compliance with regulatory standards.