Senior Clinical Project Manager

. Lead planning and execution of complex IVD clinical studies .

Posted 11/4/2026full-timeRemote • Maryland • United StatesSenior💰 $117,800 - $188,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in planning and executing complex IVD clinical studies, including protocol development, budget management, and compliance with FDA regulations and GCP standards. Proven ability to lead cross-functional teams, manage vendor relationships, and ensure participant safety throughout clinical trials.

Highest-signal resume keywords

IVD Clinical Study PlanningFDA Regulations ComplianceClinical Study Protocol DevelopmentClinical Study Budget ManagementVendor Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study Protocol DevelopmentInformed Consent Form DevelopmentCase Report Form DevelopmentClinical Safety Plan DevelopmentClinical Study Report DevelopmentClinical Study Budget TrackingOn-Site Clinical MonitoringClinical Study RegistrationGCP KnowledgeISO Standards Knowledge

Soft Skills

Excellent Communication SkillsProject Management SkillsAbility to Work IndependentlyAbility to Manage Multiple TasksTeam Collaboration

Tools & Technologies

Trial Master File (TMF)ClinicalTrials.gov

Industry Keywords

Clinical StudiesRegulatory SubmissionStudy Participant SafetyCross-Functional TeamsQuality and Compliance

About the role

Key responsibilities & impact

Lead planning and execution of complex IVD clinical studies
Develop study timelines and ensure results are completed on time and within budget
Develop clinical study protocols, informed consent forms, case report forms, and other essential documents
Develop clinical safety plans and clinical study reports for regulatory submission
Develop and track clinical study budgets, review and approve invoices, and manage monthly accruals
Oversee study team deliverables for quality and compliance
Manage external vendors and ensure deliverables meet scope, budget, and timelines
Ensure compliance with company policies, FDA regulations, ISO standards, GCP, and other applicable regulations
Identify potential problems, recommend solutions, and track lessons learned
Monitor, evaluate, and manage study participant safety
Serve as a clinical study subject matter expert on cross-functional project teams
Develop and implement standardized clinical research processes and operating procedures
Create and maintain clinical study documents in the trial master file (TMF)
Interact with investigational sites, vendors, key opinion leaders (KOLs), and consultants
Conduct on-site clinical monitoring activities as needed
Lead and participate in cross-functional team meetings
Prioritize tasks and ensure project milestones are met or exceeded
Prepare and present clinical trial progress reports to key stakeholders
Create and maintain timely clinical study registration updates

Requirements

What you’ll need

Degree level qualification; or equivalent combination of education and experience
Experience planning and executing complex IVD clinical studies
Knowledge of FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations
Clinical study protocol, informed consent form (ICF), case report form (CRF), safety plan, and clinical study report development experience
Clinical study budget development and tracking, including invoice review/approval and monthly accruals
Vendor management experience
Ability to manage multiple tasks simultaneously
Excellent communication and project management skills
Strong oral and written communication skills
Ability to work independently with minimal supervision
Ability to work as part of a diverse professional team
Clinical study registration experience, including clinicaltrials.gov or global registrations
Ability to conduct on-site clinical monitoring activities as needed
Ability to comply with Waters policies, standards and procedures
Ability to manage study participant safety throughout trials

Benefits

Comp & perks

Medical, dental, vision, health savings and flexible spending accounts
Life and disability insurance
Wellness resources
Mental health support
Disease management programs
401(k)
Deferred compensation programs
Financial counseling
DailyPay
Educational savings resources
Paid time off
Company holidays
Educational assistance
Parental leave
Adoption assistance
Backup care
Caregiving support
Employee assistance programs
Commuter benefits
Pet insurance
Legal services
Associate discount programs
Bereavement, military, personal, family and medical leave
Jury duty leave
Reward and recognition opportunities
Competitive compensation and benefits programs