Clinical Trial Manager

Civia Health•Nashville, TN

2d•Remote

About The Position

Civia 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. The 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.

Requirements

Strong ownership orientation and accountability for outcomes
Client-first perspective that guides all decision-making
Proactive, strategic, and anticipatory in identifying and managing risks
Takes immediate, decisive action when delivery deviates from plan
Brings clarity and structure to complex delivery environments
Communicates with authority, transparency, and urgency when needed
Influences cross-functional teams with credibility and confidence
Deep operational understanding of clinical trial processes and dependencies
Strong analytical capability, using data to predict, diagnose, and shape delivery outcomes
Skilled in cross-functional leadership, alignment, and escalation management
Strong regulatory, GCP, and operational literacy
Highly accountable, resilient, and composed
Energetic, organised, and adaptive
Builds confidence with stakeholders through followthrough and reliability

Responsibilities

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
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-making
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 intervention
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 expectations
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 counterparts
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 required
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