Job Details

POSITION SUMMARY

The TMF Operations Manager Contractor will play a crucial role in enhancing the Company's TMF Operations. You will lead TMF projects while overseeing KPIs, eTMF systems, and vendor activities. This involves ensuring strict adherence to SOPs, GCP, GDP, ICH E6(R2), and ALCOA+ standards, while collaborating with external vendors and internal teams to drive compliance and efficiency.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Support Clinical Operations and establish robust eTMF systems to maintain quality and compliance.
• Manage TMF projects effectively and work closely with cross-functional teams and vendors to achieve objectives.
• Serve as the primary liaison for TMF-related meetings and requests, ensuring clear communication.
• Define and implement the TMF Plan and Index for studies, including the maintenance of Expected Document Lists.
• Conduct risk-based quality control reviews in preparation for audits and inspections.
• Ensure compliance with TMF SOPs, KPIs, and global regulations to uphold industry standards.
• Perform thorough document-level quality checks and address any issues promptly.
• Generate and present TMF metrics, identifying trends in completeness, quality, and timeliness.
• Remediate documents that do not pass quality checks and provide actionable best practice recommendations.
• Coordinate the long-term storage and archiving of essential documents.
• Conduct informative TMF workshops/trainings and lead meetings with vendors/CROs.
• Embody core values: Passion, Integrity, Innovation, and Patient Focus in all activities.

REQUIREMENTS

Education

• BS/BA degree or equivalent required.

Experience

• Local candidates preferred with at least four days of on-site availability per week.
• Ability to adapt to changing priorities and evolving business needs.
• A minimum of 5 years of clinical research experience focused on document management and vendor oversight.
• Familiarity with the eTMF environment and its operational nuances.
• Exceptional communication and interpersonal skills are essential for success.
• Comprehensive understanding of the drug development process, ICH guidelines/GCP, clinical trial processes, SOPs, and relevant medical terminology.
• Self-motivated individual with strong problem-solving, organizational, and planning capabilities.
• Attention to detail and adept prioritization of tasks are critical to the role.
• Proficient in Microsoft Word, Excel, and other related software.