Note: The job is a remote job and is open to candidates in USA. Radiant Systems Inc is hiring for the position of Clinical Trial Manager. The role involves managing clinical operational and quality aspects of studies, ensuring compliance with regulations, and achieving clinical deliverables within specified timelines.
Responsibilities
- Manages all clinical operational and quality aspects of allocated studies of low to moderate complexity in compliance with ICH GCP and project-specific requirements
- Develops clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for clinical-related documents. Ensures timely setup, organization, content, and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents as required. Collaborates with the project manager to prepare, organize, and present at project meetings, including bid defense and hand-off meetings
- Collaborates with the clinical team and other departments as needed to meet project deliverables. Regularly communicates with the team and leads team meetings to ensure timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department
- Ensures achievement of the final clinical deliverable within the contractual timeline by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials
- May communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues
- May coordinate all start-up activities and ensure timely ethics committee and regulatory submissions (if appropriate). Ensures essential document quality meets Regulatory Compliance Review expectations. Reviews and follows up on all questions raised by ethics committees
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements
- Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations
- Develops clinical tools and study plans, collaborates with cross-functional stakeholders (including clinical study leadership as applicable), and leads team meetings to maintain timelines, resources, and quality. Serves as the clinical subject matter expert for the protocol and point of escalation for site managers, as applicable
- May include regional coordination with regional Clinical Management Leads (CMLs)
- Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements, and provides input on forecast estimates and resource management
- Completes trip report reviews in compliance with study plan timelines
- Performs issue escalation per study plan and is responsible for identifying and reporting site performance issues and conducting trend analysis
- May perform accompanied site visits with site managers and attend study meetings to discuss country/region start-up progress, trending, issue identification/escalation, and general site/country updates
- Generates monitoring plans and trip report completion annotations
Skills
- Blinded CTM experience required
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- Monitoring or Study Management and Oversight experience
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex and ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision-making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations (e.g., ICH/GCP, FDA guidelines, etc.)
- Good computer skills to effectively use automated systems and applications such as Outlook, Excel, Word, etc
- Flexibility to work East Coast or West Coast hours preferred
- Prior neurology therapeutic experience preferred; rare disease experience preferred
- Possibility to convert to full-time
Benefits
- Fully remote position, Monday–Friday
- Flexibility to work East Coast or West Coast hours preferred
- Possibility to convert to full-time
Company Overview
Company H1B Sponsorship