Senior Clinical Trial Manager – Sponsor Dedicated

Clinical ResearchClinical ResearchFull TimeRemoteTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Illinois + 4 moreAll locations: Illinois, Maine, North Carolina, Ohio, Rhode Island

Posted

32 days ago

Salary

$95K - $175.7K / year

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

• Lead and oversee site monitoring activities across assigned global clinical trials, ensuring effective implementation of trial-specific monitoring strategies • Consult and provide expertise to Trial Teams on monitoring methodologies, risk-based approaches, and oversight activities throughout all trial phases • Ensure trial participant safety, data integrity, and regulatory compliance in accordance with study protocols, ICH-GCP, and applicable global regulations • Manage trial-level planning, implementation, issue management, and risk mitigation related to site monitoring activities • Support inspection readiness at all times by maintaining robust oversight, documentation, and communication processes • Represent the function in meetings with investigational sites, vendors, and internal/external stakeholders, including regulatory agencies or inspectors when needed • Contribute to innovation and process improvement, including the design and implementation of new monitoring methods and digital solutions related to trial delivery • Collaborate cross-functionally with Clinical Operations, Quality, and other global teams to ensure seamless execution and alignment on monitoring objectives

Job Requirements

  • Bachelor’s degree in Life Sciences or a related discipline; advanced degree preferred
  • Demonstrated experience as a Clinical Trial Manager (or equivalent trial-level role) with accountability for end-to-end study execution, including planning, conduct, oversight, and closeout of clinical trials
  • Proven leadership of early-phase (Phase I and IIa) clinical trials, including operational strategy, risk management, and execution for complex, early-stage patient populations (not limited to first-in-human studies)
  • Oversight—not execution—of site monitoring activities, including management and performance oversight of CRAs and/or CRO partners, issue escalation, and proactive risk mitigation
  • Deep expertise in clinical operations with trial-level decision-making authority, including protocol implementation, deviation management, inspection readiness, and resolution of operational challenges
  • Strong working knowledge of ICH-GCP, Good Documentation Practice, and global regulatory requirements, with the ability to apply these principles at the study oversight level across FDA, EMA, and PMDA-regulated trials
  • Experience leading global, multi-regional trials within a matrixed, cross-functional environment, partnering closely with Clinical Operations, Data Management, Safety, Regulatory, Biometrics, and external vendors
  • Demonstrated ability to manage CROs and functional vendors, including monitoring, central labs, imaging, and other service providers, ensuring delivery against timelines, quality, and study objectives
  • Advanced project and trial management capabilities, including ownership of study timelines, milestone delivery, operational risk identification, and resolution across competing priorities
  • Excellent communication and stakeholder management skills, with the ability to lead and influence CRAs, vendors, and cross-functional teams in a global, matrixed structure
  • Demonstrated Agility, Accountability, and Intrapreneurship (AAI), with a results-oriented mindset, sound judgment, and the ability to make informed decisions in a fast-moving early-phase environment.

Benefits

  • Health benefits to include Medical, Dental and Vision
  • Company match 401k
  • Eligibility to participate in Employee Stock Purchase Plan
  • Eligibility to earn commissions/bonus based on company and individual performance
  • Flexible paid time off (PTO) and sick time

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