Clinical Trial Coordinator II - FSP in India at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Coordinator II - FSP based in India.

This role provides an opportunity to support the delivery of global clinical trials within a collaborative, international clinical operations environment.
You will provide critical administrative and technical support across study activities, with a strong focus on documentation, site activation, compliance, and trial readiness.
The position combines clinical trial coordination, data and document management, feasibility support, and collaboration with sites, vendors, and internal teams.
You will help ensure assigned activities are completed accurately, on time, and in accordance with applicable procedures and regulatory requirements.
The role also offers exposure to global teams, clinical trial systems, site start-up processes, and risk-based quality activities.
Strong organization, attention to detail, communication, and the ability to manage competing priorities will be essential to success.
This is a fully remote opportunity for a professional looking to grow within a structured, global clinical research environment.

• Coordinate assigned clinical trial activities in line with established task matrices, project plans, timelines, quality standards, and applicable procedures.
• Perform departmental, internal, country, investigator, and study file reviews, documenting findings accurately in the appropriate systems and supporting audit readiness.
• Manage clinical trial documentation, including timely processing of documents to electronic Trial Master Files, eTMF reviews, mass communications, reports, and study-specific materials.
• Review and track local regulatory documentation, reconcile study metrics and findings, and support resolution of documentation-related issues.
• Maintain vendor trackers and provide administrative and technical support to project teams and internal stakeholders.
• Support the preparation, coordination, compilation, and distribution of Investigator Site File and Pharmacy Binder materials, translations, and non-clinical study supplies.
• Maintain accurate study status information, team lists, training requirements, system access records, activity plans, and other project-level trackers.
• Provide support for clinical trial systems such as eTMF and CTMS, including document transmission, system updates, and related administrative activities.
• Support site activation and start-up activities by coordinating with internal teams, aligning activities with critical-path timelines, and assisting with regulatory submission packages.
• Assist with site feasibility activities, including developing site lists, researching internal and external sources, contacting investigators and site personnel, collecting site-interest information, and maintaining accurate contact details.
• Support the evaluation of feasibility survey data, ensuring responses are complete, logical, and aligned with the questions asked.
• Develop and maintain effective relationships with investigators, site personnel, client affiliates, and internal clinical teams as required.
• Conduct or support site contact activities, including phone interviews with physicians and site personnel, to gather information relevant to trial feasibility and optimization.
• Collaborate with Global Investigator Services and other stakeholders to resolve investigator queries and maintain accurate account and contact information.
• Monitor assigned activities against timelines, identify risks or deviations, and escalate concerns appropriately to project leads and management.
• Support risk-based monitoring activities, kick-off meetings, meeting scheduling, meeting minutes, and other project coordination needs.
• Contribute to the development and implementation of global feasibility processes, operational best practices, and process improvements.
• Train or support the onboarding of new team members and share knowledge of relevant systems, processes, and clinical trial procedures.

• Bachelor’s degree preferred, ideally supported by relevant experience in clinical research, life sciences, healthcare, or a related discipline.
• At least 2 years of relevant experience in a Clinical Trial Coordinator or comparable clinical operations role.
• Hands-on experience with Veeva eTMF and CTMS is required.
• Previous experience supporting global clinical trials and coordinating effectively with local and international project team members.
• Experience with vendor management is preferred.
• Working knowledge of clinical trial processes, applicable country regulations, ICH Good Clinical Practice (GCP), and relevant SOPs and work practice documents.
• Understanding of clinical documentation, investigator/site management, study start-up, regulatory requirements, and clinical trial systems.
• Basic knowledge of medical terminology, therapeutic areas, and local healthcare systems.
• Strong organizational and planning skills, with exceptional attention to detail and the ability to manage multiple activities simultaneously.
• Ability to analyze project data and clinical trial systems to identify discrepancies, maintain accuracy, and support efficient project delivery.
• Excellent written and verbal communication skills, including the ability to communicate effectively with medical professionals, investigators, site personnel, and internal stakeholders.
• Strong English language and grammar skills, together with proficiency in the relevant local language.
• Strong customer focus, interpersonal skills, presentation abilities, and relationship-building capabilities.
• Ability to work independently while also collaborating effectively within a matrixed, global team environment.
• Self-motivated, adaptable, and comfortable reprioritizing work in response to changing project timelines and priorities.
• Strong problem-solving skills, independent thinking, and the ability to identify, manage, and appropriately escalate risks.
• Good negotiation and stakeholder-management skills.
• Proficiency in Microsoft Office, including Word, Excel, and PowerPoint, with the ability to learn and use clinical trial databases and specialized software.
• Willingness and ability to successfully complete required clinical training programs.
• Ability to occasionally travel to clinical sites or other locations when required.

• Fully remote: Work remotely from India in a global clinical research environment.
• Full-time position: Standard Monday-to-Friday work schedule.
• Global exposure: Collaborate with international clinical operations teams, investigators, sites, vendors, and project stakeholders.
• Professional development: Opportunity to strengthen expertise across clinical trial coordination, site activation, feasibility, documentation, and regulatory processes.
• Learning opportunities: Exposure to clinical trial technologies, systems, processes, and evolving industry best practices.
• Career growth: Opportunities to take on additional responsibilities, support new team members, and contribute to process improvement initiatives.
• Collaborative environment: Work within a structured, cross-functional and globally connected clinical operations organization.
• Purpose-driven work: Contribute to clinical research programs that support the development of therapies and healthcare solutions.
• Flexibility: Home-office environment with occasional travel or site visits where required.