Clinical Trial Manager
Civia Health
46d ago
0ManagementUnited Stateshimalayas
Clinical-Trial-ManagerClinical-OperationsClinical-Project-ManagerClinical-Research-ManagementSite-managementSenior-Clinical-Trial-ManagerSenior
Job Description
Location: Remote, US East CoastJob Type: Full-TimeReports To: Head of Country Delivery Internal Team Title: Clinical Trial ManagerJOIN US AT CIVIA HEALTHCivia Health operates a nextgeneration SMO model designed for predictable, highquality clinical trial delivery. Our approach depends on seamless alignment across specialised functions — Site Management, Recruitment, Regulatory, Data Quality, and Safety — supported by disciplined governance, transparency, and performance accountability.Within this model, the Clinical Trial Manager (CTM) is the country-level owner of study delivery outcomes and the primary advocate for the client within Civia. The CTM ensures that all functional areas execute to the standards, timelines, and commitments agreed with sponsors, acting swiftly and decisively whenever delivery performance is at risk.PURPOSE OF THE JOBThe CTM provides overarching leadership, coordination, and delivery accountability for assigned studies within a country. The role brings together all functional contributors under a unified delivery framework, ensuring that study commitments are met reliably and consistently.The CTM maintains a forward-looking view on delivery health, proactively identifies risks, and takes immediate action — influencing direction, coordinating interventions, and holding functions to account so that client expectations are upheld without compromise.CORE ACCOUNTABILITY• Full accountability for country-level study delivery and performance
• Serve as the client’s voice within Civia, ensuring their priorities, timelines, and standards are understood and met across all functions
• Maintain disciplined oversight of start-up, recruitment, regulatory progress, data quality, and site performance
• Drive immediate cross-functional action when performance deviates from plan
• Lead structured governance routines with clarity, transparency, and solution orientation
• Ensure ongoing audit and inspection readiness across all study activities
KEY RESPONSIBILITIES1. Delivery Leadership & Performance Management• Own the country-level delivery plan, defining clear expectations and performance milestones
• Monitor real-time delivery indicators and immediately initiate cross-functional action when risks or slippage appear
• Ensure all operational decisions and adjustments reflect client priorities and commitments
• Maintain an integrated delivery picture that enables proactive decision-making2. Cross-Functional Alignment & Accountability• Work closely with Site Management Directors, Recruitment, Regulatory, Data, Quality, and Safety teams to ensure consistent execution
• Provide structured oversight, ensuring each function is aligned to timelines, quality expectations, and client deliverables
• Facilitate cross-functional performance reviews and ensure timely resolution of bottlenecks
• Escalate appropriately and constructively when risks require leadership intervention3. Recruitment & Enrollment Governance• Oversee recruitment performance and ensure projected velocity supports country delivery commitments
• Leverage funnel data and insights to forecast outcomes and shape resourcing or tactical adjustments
• Ensure recruitment governance reflects both operational requirements and client expectations4. Regulatory & Start-Up Governance• Maintain continuous visibility into submissions, approvals, and contracting progression
• Ensure clear alignment between regulatory timelines, site readiness, and client milestones
• Communicate regulatory status effectively to internal leadership and sponsor counterparts5. Data Quality, Compliance & Safety Oversight• Maintain oversight of data timeliness, data hygiene, deviation trends, and audit readiness
• Ensure alignment with quality and safety teams to maintain compliance and reporting standards
• Support the development and execution of CAPAs and improvement plans where required6. Client Leadership & Communication• Act as the country-level delivery representative to sponsor project teams
• Provide transparent, future-focused performance updates, highlighting risks and recommended actions
• Uphold a client-first mindset, ensuring Civia’s internal teams understand and deliver to sponsor expectations
• Build strong trust through reliability, consistency, and performance transparency
PERFORMANCE MEASURES (KPIS)• Enrollment vs Commitment: ≥100%
• Recruitment Velocity & Funnel Health: On or ahead of forecast
• Start-Up Timelines: Delivered as planned
• Data Entry Timeliness: Within 24–48 hours• Query Aging: ≤7 days• Critical Deviations: ZeroSAE Reporting Compliance: 100%
• Sponsor Satisfaction: Strong governance feedback and repeat awards
IDEAL PHENOTYPE
Mindset• Strong ownership orientation and accountability for outcomes
• Client-first perspective that guides all decision-making
• Proactive, strategic, and anticipatory in identifying and managing risksBehaviour• Takes immediate, decisive action when delivery deviates from plan
• Brings clarity and structure to complex de
