Senior Central Monitor

Lifelancer

. Perform remote site monitoring and management activities for assigned projects .

Posted 9/18/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring and management, with a strong focus on compliance with FDA regulations, ICH GCP guidelines, and effective communication with stakeholders. Proficient in utilizing clinical trial execution systems to enhance project efficiencies and ensure data integrity.

Highest-signal resume keywords

Clinical Trial Management SystemsElectronic Data Capture SystemsElectronic Document Management SystemsStudy CoordinationRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Risk AssessmentDocument CollectionStudy Data ReviewProject PlanningQuality Assurance Concepts

Soft Skills

Effective CommunicationInterpersonal SkillsOrganizational SkillsAttention to DetailCross-Functional Collaboration

Tools & Technologies

CluePoints RBQM System

Industry Keywords

BiotechnologyPharmaceuticalICH GuidelinesGCP GuidelinesProPharma Group SOPs

About the role

Key responsibilities & impact

Perform remote site monitoring and management activities for assigned projects
Support clinical monitoring teams in implementing study strategies, initiatives, processes, and standards
Support collection of data and report generation for recruitment plans, enrollment, drug supply status, site payment status, and other clinical trial tracking
Support data risk assessments as assigned
Support monitoring teams throughout the study, including communication with clinical site institutions as appropriate
Support document collection, visit preparation, study data review, and central monitoring activities as assigned
Follow Standard Operating Procedures, regulatory requirements, ICH and GCP guidelines, and study-specific plans
Perform other duties as assigned

Requirements

What you’ll need

Effective communication and interpersonal skills with ability to partner with cross-functional internal and external stakeholders
Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures
Ability to contribute to development of tools and processes that increase measured project efficiencies
Proficiency with clinical trial execution systems, including Electronic Document Management Systems, Electronic Data Capture Systems, and Clinical Trial Management Systems
Good understanding of general quality assurance concepts and practices
Highly organized with strong attention to detail
Bachelor’s degree preferred
Persons without a formal degree may be considered if they have comparable depth and breadth of training and experience and meet job-specific criteria
Minimum 3 years of experience in study coordination and in-house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or a relevant regulated environment
Working knowledge of CluePoints RBQM System desired
Long-haul COVID/Pulmonary experience desired
Compliance with FDA and/or local regulations, ICH GCPs, ProPharma Group SOPs, and project plans

Benefits

Comp & perks

Remote working support
Hybrid working encouraged for new hires within a reasonably short commute of an office, as agreed with the manager
Equal Opportunity Employer workplace
Diversity, equity, and inclusion commitment
Safe and empowering workplace environment