FSP Clinical Trial Coordinator - eTMF

Accountabilities:: Maintain and manage Trial Master File (TMF/eTMF) and Investigator Site File (ISF) documentation, ensuring completeness, accuracy, quality, and audit readiness throughout the clinical trial lifecycle. Support clinical study setup and execution by coordinating trial materials, essential site documentation, and regulatory submission activities. Manage clinical trial systems, including CTMS, Activate, and eTMF platforms, ensuring that study databases, trackers, reports, and access permissions remain accurate and up to date. Coordinate site qualification, feasibility assessments, site start-up activities, and investigator documentation requirements. Support the preparation, collection, review, filing, and maintenance of essential clinical trial documents in accordance with applicable quality standards. Coordinate study supplies, vendor interactions, logistics, and communication with clinical research sites to facilitate smooth trial operations. Monitor study progress and performance metrics, maintain accurate databases and tracking tools, and ensure timely completion of assigned activities. Collaborate with clinical study teams, investigators, vendors, and cross-functional stakeholders to address documentation gaps and support efficient study delivery. Assist with regulatory documentation and site start-up processes, ensuring alignment with applicable clinical trial requirements. Support compliance with ICH-GCP guidelines, internal Standard Operating Procedures (SOPs), and relevant regulatory requirements. Participate in study calls and meetings, prepare and maintain accurate meeting minutes, and follow up on assigned action items. Maintain clear and organized study records while ensuring timely communication of progress, outstanding tasks, and potential issues to relevant stakeholders. Requirements: Bachelor's degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related discipline. 1–3 years of professional experience in Clinical Research, Clinical Operations, Clinical Trial Coordination, or related clinical trial support functions. Hands-on experience supporting global clinical trials and working within international clinical research environments. Practical experience using electronic Trial Master File (eTMF) systems, preferably Veeva. Good understanding of TMF/eTMF and Investigator Site File (ISF) management, including essential document collection, review, filing, and quality control. Familiarity with clinical trial management systems and platforms, including CTMS, Activate, and other clinical research technologies. Understanding of clinical trial processes, study documentation requirements, and applicable regulatory procedures. Knowledge of ICH-GCP guidelines, Good Documentation Practices, SOPs, and clinical research compliance requirements. Experience supporting regulatory documentation, site qualification, feasibility assessments, and site start-up activities. Familiarity with study trackers, reporting tools, database maintenance, and clinical trial access management. Hands-on experience preparing and documenting minutes of meetings, particularly for clinical study calls, and tracking follow-up actions. Proficiency in Microsoft Office applications, particularly Excel, Word, PowerPoint, and Outlook. Strong organizational and administrative skills, with excellent attention to detail and the ability to manage multiple priorities and deadlines. Excellent written and verbal communication skills, with the ability to collaborate effectively with investigators, research sites, vendors, and cross-functional teams. Strong documentation, analytical, and problem-solving abilities, combined with a proactive and quality-focused approach. Ability to work independently while contributing effectively to a collaborative, international clinical research environment. Benefits: Employment type: Full-time opportunity. Work arrangement: Fully remote position based in India. Working schedule: Standard Monday-to-Friday working schedule. Professional development: Opportunity to build specialized expertise in clinical trial coordination, eTMF management, and global clinical operations. Technical exposure: Hands-on experience with clinical research platforms, including Veeva eTMF, CTMS, and Activate. International experience: Opportunity to contribute to global clinical trials and collaborate with international clinical research teams. Career growth: Develop valuable skills in clinical documentation, regulatory processes, site management, and clinical trial administration. Meaningful impact: Contribute to clinical research activities supporting the development of innovative treatments and improved patient outcomes. Collaborative environment: Work alongside experienced clinical research professionals and cross-functional teams. Compensation and additional benefits: Salary, healthcare coverage, and other employment benefits have not been specifically disclosed and may be discussed during the recruitment process.