Project Specialist (clinical experience)

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. Technical Skills: Advanced Microsoft Excel proficiency for financial reviews, data analysis, and reporting, along with working knowledge of Microsoft Word, PowerPoint, and other Microsoft Office applications. Project Management Skills: Strong organizational, planning, multitasking, and time management abilities, with the capacity to manage competing priorities and meet demanding deadlines. Communication and Collaboration: Excellent written and verbal communication skills, effective interpersonal abilities, and the confidence to coordinate with cross-functional teams and external stakeholders. Analytical Thinking: Strong attention to detail, problem-solving capabilities, and the ability to identify operational risks, investigate discrepancies, and recommend practical solutions. Adaptability and Ownership: Ability to work independently and collaboratively, respond effectively to changing priorities, and remain productive under pressure. Preferred Certifications: Certification in clinical project management or a related discipline is an advantage. Good Clinical Practice (GCP) certification is also preferred. Benefits Opportunities for professional development, career progression, and long-term growth within the clinical research industry. Supportive management and access to technical, therapeutic-area, and role-specific training. Peer recognition initiatives and a total rewards program. An inclusive and collaborative work environment that values diverse perspectives, teamwork, and continuous learning. Opportunities to collaborate with multidisciplinary and international teams on clinical research projects. The opportunity to contribute to the development of innovative treatments and healthcare solutions that can improve patient outcomes. Exposure to clinical studies across different therapeutic areas and stages of development. Compensation, healthcare coverage, leave entitlements, and work arrangements: Specific details were not provided in the original job description and should be confirmed during the recruitment process.