Clinical Trial Manager

Posted Yesterday
Be an Early Applicant
Country States, Pájaros Barrio, Bayamón, PRI
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Country-level owner of clinical study delivery: lead cross-functional teams (site, recruitment, regulatory, data, safety), manage delivery plans, forecast recruitment, ensure compliance/GCP and audit readiness, and act as sponsor-facing delivery representative.
Summary Generated by Built In

Location: Remote, US East Coast
Job Type: Full-Time
Reports To: Head of Country Delivery 
Internal Team Title: Clinical Trial Manager

 

JOIN US AT CIVIA HEALTH

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.

 

PURPOSE OF THE JOB

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.

 

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 RESPONSIBILITIES

1. 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-making

2. 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 intervention

3. 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 expectations

4. 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 counterparts

5. 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 required

6. 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: Zero
• SAE 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 risks

Behaviour

• 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

Capabilities

• 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

Personal Traits

• Highly accountable, resilient, and composed
• Energetic, organised, and adaptive
• Builds confidence with stakeholders through followthrough and reliability
 

ROLE DIFFERENTIATION

The CTM is the central delivery authority for assigned studies at the country level. While functional teams execute their specialised responsibilities, the CTM ensures alignment, performance, and continuity — taking direct, immediate action to safeguard delivery outcomes and maintain the highest level of client confidence.

 

EXECUTIVE ONE-LINER

The CTM is the country’s delivery leader and the client’s voice within Civia — ensuring every function aligns, performs, and responds rapidly to protect timelines, quality, and sponsor commitments. 

CIVIA HEALTH VALUES IN ACTION

• Empathy: Listen first — understand sponsors, partners, and patients before acting.
• Integrity: Do the right thing, even when it’s not the easy thing.
• Trust: Deliver on promises — every time.
• Community: Collaborate generously to elevate the collective good.
• Relentless Self-Improvement: Learn, adapt, and grow continuously.
 

WHY CIVIA HEALTH

Join a purpose-driven organization redefining clinical research by connecting science with humanity. As part of our leadership team, you’ll shape how clinical trials are delivered, expand access for patients, and accelerate innovation for the communities we serve.

Ready to Make an Impact?

• Mission with Meaning: Be part of a purpose-led team committed to health equity and real-world impact.
• Startup Energy, Proven Expertise: Work fast, adapt quickly, and help build something new; guided by seasoned visionary professionals who’ve seen what needs to change.
• People First Culture: We care deeply about our patients, participants, and each other. Collaboration, transparency, and bold, straight-talking are core to how we work.
• Invested in Your Growth: We don’t just hire for today; we’re building the leaders and changemakers of tomorrow. 

If you’re ready to be part of something meaningful—and work with people who care deeply about doing good work—apply today by submitting your resume and cover letter to the link above. We’re excited to learn more about you!

Skills Required

  • Deep operational understanding of clinical trial processes and dependencies
  • Proven cross-functional leadership and country-level study delivery experience
  • Strong knowledge of regulatory requirements and Good Clinical Practice (GCP)
  • Experience overseeing recruitment, enrollment governance, and start-up timelines
  • Demonstrated capability in data quality oversight, CAPA development, and audit readiness
  • Strong analytical skills using funnel and delivery data to forecast and shape outcomes
  • Client-facing communication skills and ability to represent sponsor priorities
  • Ability to run structured governance routines and escalate effectively
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The Company
81 Employees
Year Founded: 2025

What We Do

Civia Health is a clinical study network and digital platform that specializes in high-performance site management and patient recruitment for chronic ambulatory conditions. The company operates retail-based research sites and a participant registry, Thrive with Civia, to streamline recruitment using AI-enabled tools, aiming to make clinical trials more accessible and human-centered for underrepresented communities.

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