Senior Clinical Trial Manager

Atrium Therapeutics

. Accountable for overall clinical study operations, including CRO and vendor management, project plans, budgets, and resource management .

Posted 10/12/2026full-timeRemote • California • United StatesSenior💰 $171,000 - $189,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical study operations, including CRO management, regulatory compliance, and budget oversight. Proven ability to lead cross-functional teams, develop operational plans, and ensure quality deliverables in clinical trials.

Highest-signal resume keywords

Clinical Operations ManagementCRO ManagementGlobal Clinical Trial ExperienceICH/GCP KnowledgeBudget Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study OperationsProject ManagementData ReviewRegulatory ComplianceClinical Trial Protocol DevelopmentStudy Timeline ManagementTraining DevelopmentRisk ManagementInspection ReadinessClinical Research Processes

Soft Skills

Attention to DetailOrganizational SkillsCommunication SkillsAnalytical SkillsRelationship Building

Tools & Technologies

SmartsheetMS ExcelETMF Management

Industry Keywords

Life SciencesRare DiseasePhase I-III TrialsCROClinical Research Associate

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Accountable for overall clinical study operations, including CRO and vendor management, project plans, budgets, and resource management
Lead development of study operational plans and contribute to functional area plans and processes
Oversee CROs, vendors, and sites while ensuring GCP and regulatory compliance
Represent clinical operations in cross-functional teams
Develop and manage study timelines and budgets with the Clinical Operations Lead, internal leadership, and CROs
Manage clinical study vendors and establish deliverables and KPIs
Develop study-specific training for site staff, CRAs, and vendors and present at Investigator and Kick-off meetings
Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees
Develop clinical monitoring strategies to meet timelines and ensure quality deliverables
Manage and oversee eTMF structure, plans, and quality
Manage investigator selection, drug supply projections, study start-up, recruitment and retention, data collection, database locks, drug accountability, and study closeout
Contribute to clinical trial outlines, protocols, informed consent forms, and clinical study reports
Lead or collaborate on project plans, training, system builds, CRF designs, and UATs
Identify and resolve issues and risks with cross-functional teams and service providers
Collaborate with data management and CRAs to ensure data quality and cleaning timelines
Perform clinical data review, including query generation, as needed
Contribute to process improvements, initiatives, and SOPs
Provide direction and mentoring to junior team members
Escalate CRA performance and site compliance issues
May have line management responsibilities

Requirements

What you’ll need

Bachelor’s degree required, preferably in the Life Sciences or equivalent
Minimum of 8-10 years of experience in clinical operations is required
Experience managing a CRO and a complex study in a previous Clinical Trial Manager or equivalent position
Global Clinical Trial experience in Phase I-III
Experience in Rare Disease required; cardiovascular experience is a plus
Inspection readiness and inspection experience is a plus
Exceptional attention to detail and organizational skills
Excellent oral and written communication, analytical, and project management skills
Ability to develop and maintain strong, collaborative relationships with key internal and external stakeholders
Ability to multitask, deal with conflict and obstacles, and work in a fast-paced environment
Ability to quickly learn and use technical applications
Preferred experience using Smartsheet/MS Excel or equivalent
Ability to manage budgets and forecast
Prior auditing experience preferred
Prior experience working as a Clinical Research Associate (CRA) preferred
In-depth knowledge of ICH/GCP, regulatory guidelines/directives, drug development, and clinical research processes
Team leadership experience within a cross-functional matrix environment
Ability to travel nationally and globally for meetings and conferences, approximately 10%-15%

Benefits

Comp & perks

Stock options
401(k) with an employer match
Medical coverage
Dental coverage
Vision coverage
LTD coverage
Unlimited time off, including summer & winter breaks
Internally developed learning and development programming
Job-specific training offered by industry
Education reimbursement program