Note: The job is a remote job and is open to candidates in USA. Radiant Systems Inc is seeking a Clinical Trial Manager to oversee the clinical operational and quality aspects of allocated studies. The role involves managing clinical activities, ensuring compliance with regulations, and achieving deliverables within specified timelines.

Responsibilities

• Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer
• Interprets data on project issues and makes good business decisions with support from experienced team members or line manager
• Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations
• Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team
• Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP
• 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 providing clinical related documents
• Ensures timely set up, 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 client meetings, including bid defense and hand-off meetings
• Collaborates with the clinical team and other departments as needed to meet deliverables of the project
• Regularly communicates with the team and leads team meetings to ensure that 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 time period specified 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 issues such as protocol, patient participation, case report form completion and other study-related issues
• May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed
• Ensures that essential document quality meets the expectation of Regulatory Compliance Review
• Reviews and follows up on all questions raised by the 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 client CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality
• Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable
• May include regional coordination with regional 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 timeline
• Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis
• May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss, but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates
• Generate monitoring plan and trip report completion annotations

Skills

• Blinded CTM experience
• Flexibility to work east coast or west coast hours
• 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
• Prior neurology therapeutic experience
• Rare-disease experience

Company Overview

Company H1B Sponsorship