Project Manager – Clinical Trials

allied executive solutions

. Develop and maintain project plans, timelines, budgets, and risk management strategies for assigned clinical trials .

Posted 9/18/2026contractNew Jersey • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including project planning, budget oversight, and compliance with ICH-GCP and FDA/EMA regulations. Proven ability to coordinate cross-functional teams and manage vendor relationships while ensuring the rights and safety of research participants.

Highest-signal resume keywords

Clinical Trial ManagementICH-GCP ComplianceProject Budget ManagementVendor Relationship ManagementClinical Trial Documentation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementProject PlanningBudget OversightRisk ManagementData Quality MonitoringClinical Trial Phases I–IVStudy Design UnderstandingRegulatory ComplianceMulti-Site Trial ManagementTherapeutic Area Expertise

Soft Skills

Organizational SkillsProblem-Solving SkillsCommunication Skills

Tools & Technologies

Clinical Trial Management Systems (CTMS)EDC PlatformsMicrosoft ProjectMicrosoft Excel

Certifications & Qualifications

PMPCCRAACRPSoCRA

Industry Keywords

Clinical ResearchCRO ManagementRegulatory AffairsPharmacovigilanceInspection Readiness

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Develop and maintain project plans, timelines, budgets, and risk management strategies for assigned clinical trials
Manage day-to-day trial operations across start-up, enrollment, monitoring, and close-out
Serve as liaison between sponsors, CROs, investigators, IRBs/ECs, and internal stakeholders
Oversee site selection, activation, and performance
Monitor trial budgets, forecast expenditures, and manage vendor/CRO contracts and deliverables
Ensure compliance with ICH-GCP, FDA/EMA regulations, and applicable local laws
Track and report enrollment, data quality, and milestone progress
Identify, assess, and mitigate risks and issues affecting timelines, budget, or quality
Coordinate with Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams
Manage clinical trial documentation, including the Trial Master File, and ensure inspection readiness
Lead internal team meetings, sponsor calls, and investigator meetings
Support audits and regulatory inspections as needed
Uphold the organization’s mission, values, and commitment to ethical research
Work with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, public health, or related field
3–5+ years of experience in clinical trial management, clinical research, or clinical operations
Solid working knowledge of ICH-GCP guidelines and applicable regulatory frameworks, including FDA and EMA
Experience managing project timelines, budgets, and vendor relationships
Understanding of clinical trial phases I–IV and study designs
Excellent organizational, problem-solving, and communication skills
Proficiency with clinical trial management systems (CTMS), EDC platforms, and Microsoft Project/Excel
PMP, CCRA, or ACRP/SoCRA certification preferred
Experience managing multi-site or global clinical trials preferred
Relevant therapeutic area expertise preferred
Experience working directly with CROs and central labs preferred
Ability to protect research participant rights, safety, dignity, and confidentiality
Ability to follow organizational policies, research protocols, regulatory requirements, and compliance standards
Some local travel, evening hours, or flexible scheduling may be required depending on study needs

Benefits

Comp & perks

Equal opportunity employment
Training opportunities
Team meetings and quality improvement activities
Performance review processes
Flexible scheduling may be available depending on study needs