Thermo Fisher Scientific

Manager

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
• Develop clinical tools and contribute to the Data Quality Plan and Master Action Plan
• Ensure timely setup, organization, content, and quality of Trial Master File sections
• Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings
• Collaborate with clinical teams and departments to meet project deliverables
• Lead team meetings and maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Archive study documents and materials in a timely manner
• Prepare and monitor clinical timelines and metrics, provide project status updates, and implement recovery actions
• Review monitoring visit reports, manage CRF collection and query resolution, and monitor clinical trial performance
• Conduct Accompanied Field Visits and manage project financials where applicable
• Communicate with study sites regarding protocols, patient participation, CRF completion, and related issues
• Coordinate study start-up activities and ethics committee and regulatory submissions where applicable
• Ensure essential document quality and follow up on ethics committee questions
• Contribute to clinical activity forecasts and manage clinical resources, responsibilities, delegations, and additional resource needs

Clinical Team Manager – FSP

Principal

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor procedures and guidelines across different monitoring environments
• Ensure trials comply with approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Protect subjects' rights, well-being and data reliability
• Ensure audit readiness and develop collaborative relationships with investigational sites
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking and problem-solving to identify site-process failures and corrective/preventive actions
• Ensure data accuracy through SDR, SDV and CRF review during on-site and remote monitoring
• Assess investigational product through inventory and records review
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems such as CTMS and perform required quality-control checks
• Participate in investigator meetings and identify potential qualified investigators
• Initiate clinical trial sites and make compliance recommendations
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, newsletters, trip report reviews and CRA team calls
• Facilitate communication between sites, the client company and the project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Contribute to project work and process-improvement initiatives
• Travel frequently to site locations, generally 60–80%, with possible extended overnight stays

Clinical Team Manager – FSP

Principal CRA