Project Specialist (clinical experience)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Project Specialist (Clinical Experience) based in India. Join a collaborative clinical research environment dedicated to advancing healthcare and accelerating the development of innovative treatments. In this role, you will coordinate clinical study activities, manage timelines, and support the successful delivery of clinical trials. You will work closely with cross-functional teams, including clinical operations, regulatory affairs, and data management, to ensure project milestones are achieved efficiently. Your expertise will contribute to maintaining regulatory compliance, optimizing study budgets, and resolving operational challenges. You will also help standardize processes, monitor study performance, and develop effective patient recruitment strategies. This opportunity is ideal for an organized, detail-oriented professional who thrives in a dynamic environment and wants to make a meaningful contribution to clinical research and patient outcomes. Accountabilities - Clinical Project Planning: Develop, coordinate, and communicate clinical study timelines, ensuring key milestones and deliverables are achieved according to project objectives. - Cross-Functional Coordination: Gather input from clinical, regulatory, data management, and other relevant teams to develop comprehensive project plans and facilitate timely execution. - Study Operations and Compliance: Oversee clinical trial activities, resolve operational challenges, and ensure compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable country-specific regulations. - Process Improvement: Promote consistency across clinical studies by standardizing procedures, implementing best practices, and supporting continuous operational improvement.

- Site and Vendor Management: Support the selection of clinical research sites and vendors, participate in contract negotiations, and maintain productive relationships to ensure quality and timely service delivery. - Budget Management and Financial Reporting: Prepare and monitor clinical study budgets, review expenditures, perform financial analysis, and help ensure projects remain within approved financial parameters. - Performance Monitoring: Track study progress, monitor key performance indicators, identify deviations from established plans, and follow up with project team members and line managers to implement corrective actions. - Clinical Development Strategy: Support the development and implementation of clinical development strategies, ensuring alignment between study activities and overall project goals. - Patient Recruitment and Enrollment: Develop and coordinate recruitment strategies, identify target populations, support the creation of recruitment materials, and monitor enrollment progress against study targets. - Reporting and Documentation: Maintain accurate project records, prepare status reports, and communicate risks, progress, and operational updates to relevant stakeholders. Requirements - Education: High school diploma or equivalent required; an associate degree or higher in a relevant field is preferred. Equivalent combinations of education and experience may be considered. - Clinical Experience: At least one year of relevant experience is indicated in the initial role requirements, while the detailed qualifications specify a minimum of three years in clinical project management or a related field. - Clinical Research Knowledge: A solid understanding of clinical trial processes, study coordination, regulatory requirements, and clinical project management principles. - Regulatory Compliance: Familiarity with SOPs, ICH-GCP guidelines, and country-specific clinical research regulations.