Associate Manager, Clinical Operations Site Management

Worldwide Clinical Trials

. Lead and support a team of Clinical Research Associates (CRAs) and In-House Clinical Research Associates (IHCRAs) .

Posted 11/6/2026full-timeRemote • North Carolina • United StatesMid-Level💰 $97,000 - $222,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in clinical research management, including team leadership, performance monitoring, and compliance with FDA regulations and ICH Guidelines. Proficient in training and developing Clinical Research Associates while ensuring adherence to clinical research principles and quality metrics.

Highest-signal resume keywords

Clinical Research ManagementFDA RegulationsICH GuidelinesElectronic Data Capture SystemsPerformance Monitoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceKnowledge of Therapeutic AreasData Collection and EditingPerformance ReviewsCorrective and Preventive Actions

Soft Skills

Interpersonal SkillsWritten CommunicationVerbal CommunicationProblem-SolvingAttention to Detail

Tools & Technologies

InFormMedidataMicrosoft WordMicrosoft ExcelMicrosoft Outlook

Industry Keywords

Clinical Research PrinciplesHIPAAStandard Operating ProceduresSite Visit Report ComplianceTMF Readiness

About the role

Key responsibilities & impact

Lead and support a team of Clinical Research Associates (CRAs) and In-House Clinical Research Associates (IHCRAs)
Lead interviewing, selection, and onboarding of permanent and contract CRAs and IHCRAs
Coach and develop CRAs and IHCRAs through one-to-one discussions, performance reviews, mentoring, and on-site observation or assessment visits
Ensure team members receive timely training for required site visits and billable monitoring activities
Monitor quality and performance metrics, including site visit report compliance, source data verification metrics, TMF readiness, expense submissions, and project status
Address performance concerns, act as an escalation point for project teams, and develop corrective and preventive actions (CAPAs) when required
Manage team utilization and workload by reviewing timecards, contractor hours, assignments, and resource allocation
Support employee performance and engagement, including employee relations matters and performance concerns
Review and approve CRA and IHCRA paid time off requests and non-billable expenses
Support Clinical Operations leadership as needed

Requirements

What you’ll need

Four-year college curriculum with a major concentration in biological, physical, health, pharmacy, or another related science, together with six years of clinical research experience as a CRA; or a two-year college curriculum or equivalent education/training with seven years of CRA experience; or eight years of clinical research experience as a CRA or in another position directly related to clinical research within a pharmaceutical or biotechnology company
Strong knowledge of clinical research principles and processes, FDA regulations, ICH Guidelines, HIPAA, and standard operating procedures
Ability to understand multiple study protocols, with knowledge of therapeutic areas and clinical data collection and editing
Experience navigating electronic data capture systems such as InForm and Medidata
Strong planning, organization, problem-solving, decision-making, and attention-to-detail skills
Excellent interpersonal, written, and verbal communication skills, including proficiency in English
Working knowledge of Microsoft Word, Excel, and Outlook
Ability to meet the role’s travel requirements and hold a valid passport

Benefits

Comp & perks

Competitive benefits package depending on location
Inclusive and equitable workplace
Equal employment opportunities
Employee development, coaching, training, and mentoring opportunities