Clinical Trial Implementation Specialist

• Trial Planning: Collaborate with cross-functional teams, including researchers, investigators, and regulatory affairs professionals, to develop and refine the trial protocol, study design, and implementation plan
• Regulatory Compliance: Ensure compliance with applicable regulations, guidelines, and ethical standards governing clinical research, such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulatory requirements
• Protocol Development: Contribute to the development of clinical trial protocols, case report forms (CRFs), informed consent forms (ICFs), and other trial-related documentation to ensure clarity, accuracy, and completeness
• Study Start-up: Coordinate the start-up activities, including site selection, investigator meetings, contract and budget negotiations, ethics committee submissions, and study initiation visits, to ensure timely and efficient trial initiation
• Investigator and Site Support: Provide training and support to investigators and site staff on study protocol, data collection procedures, and regulatory requirements to ensure proper trial conduct and data integrity
• Vendor Management: Collaborate with external vendors, such as central laboratories, data management organizations, and clinical research organizations (CROs), to oversee their activities, ensure quality deliverables, and maintain effective communication
• Data Management: Collaborate with data management teams to ensure accurate and timely data collection, validation, and cleaning, adhering to data management plans and standard operating procedures (SOPs)
• Risk Assessment and Mitigation: Identify potential risks and challenges in trial implementation, develop risk mitigation strategies, and implement corrective actions to ensure trial success
• Documentation and Reporting: Maintain comprehensive and accurate trial documentation, including study files, trial master files, and regulatory submissions
• Prepare progress reports, study metrics, and presentations for internal and external stakeholders
• Quality Assurance: Conduct periodic quality control checks and audits to ensure adherence to protocols, standard operating procedures, and regulatory requirements
• Address any deviations or non-compliance issues appropriately
• Continuous Improvement: Contribute to process improvement initiatives by identifying opportunities for enhancing trial implementation efficiency, data quality, and participant safety

Qualifications and Skills:

• Bachelor's degree in life sciences, healthcare, or a related field (advanced degree preferred)
• In-depth knowledge of clinical trial regulations, guidelines, and GCP
• Strong understanding of clinical trial processes and study management
• Experience in clinical trial implementation, preferably in a pharmaceutical, biotechnology, or CRO setting
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
• Excellent organizational and project management skills
• Strong communication and interpersonal skills
• Attention to detail and ability to work independently and as part of a team
• Problem-solving and decision-making abilities
• Proficiency in relevant software applications (eg, Microsoft Office suite)