Project Manager Clinical Trials

allied executive solutions; United States; Hybrid; USD 110,000 - 160,000; Full time

Job summary

Allied Executive Solutions is seeking a Clinical Trials Project Manager to lead end-to-end planning, execution and oversight of clinical studies, ensuring on-time, on-budget delivery with full regulatory compliance. You will serve as the core liaison among sponsors, CROs, investigators and internal teams, driving start-up through close-out.

Responsibilities include creating comprehensive plans, managing budgets, monitoring enrollment and data quality, and guiding TMF readiness while mitigating

Qualifications

• Bachelor's degree in life sciences, nursing, public health, or related field (advanced degree a plus).
• 3–5+ years of experience in clinical trial management, clinical research, or clinical operations.
• Solid working knowledge of ICH-GCP guidelines and regulatory frameworks (FDA, EMA).
• Experience managing project timelines, budgets, and vendor relationships.
• Strong understanding of clinical trial phases (I–IV) and study designs.
• Excellent organizational, problem-solving, and communication skills.
• Proficiency with CTMS, EDC platforms, and Microsoft Project/Excel.

Responsibilities

• Develop and maintain project plans, timelines, budgets and risk strategies.
• 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 with regulatory timelines.
• Monitor budgets, forecast expenditures and manage vendor/CRO contracts.
• Ensure compliance with ICH-GCP and FDA/EMA regulations throughout the trial lifecycle.
• Track enrollment, data quality and milestones to leadership and sponsors.
• Identify and mitigate risks impacting timelines, budget or quality.
• Coordinate with Data Management, Biostatistics, Regulatory Affairs and PV teams.
• Manage TMF documentation and inspection readiness.
• Lead internal meetings, sponsor calls and investigator meetings.
• Support audits and regulatory inspections as needed.

Skills

Leadership

Cross-functional leadership

Risk assessment

Attention to detail

Regulatory compliance

Stakeholder communication

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Tools

CTMS

EDC platforms

Microsoft Project

Excel

Job description

Position Summary

The Clinical Trials Project Manager is responsible for the end-to-end planning, execution, and oversight of clinical research studies, ensuring trials are delivered on time, within budget, and in full compliance with regulatory requirements and Good Clinical Practice (GCP) standards. This role serves as the primary point of accountability for cross-functional trial teams, sponsors, CROs, and site personnel, driving studies from start-up through close-out.

Essential Duties and Responsibilities

• Develop and maintain comprehensive project plans, timelines, budgets, and risk management strategies for assigned clinical trials
• Manage day-to-day trial operations across all phases: start-up, enrollment, monitoring, and close-out
• Serve as the primary liaison between sponsors, CROs, investigators, IRBs/ECs, and internal stakeholders
• Oversee site selection, activation, and performance, ensuring adherence to protocol and regulatory timelines
• Monitor trial budgets, forecast expenditures, and manage vendor/CRO contracts and deliverables
• Ensure compliance with ICH-GCP, FDA/EMA regulations, and applicable local laws throughout the trial lifecycle
• Track and report on enrollment, data quality, and milestone progress to senior leadership and sponsors
• Identify, assess, and mitigate risks and issues that may impact trial timelines, budget, or quality
• Coordinate with Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams
• Manage clinical trial documentation, including the Trial Master File (TMF), ensuring inspection readiness
• Lead and facilitate internal team meetings, sponsor calls, and investigator meetings
• Support audits and regulatory inspections as needed

Required Qualifications

• Bachelor's degree in life sciences, nursing, public health, or related field (advanced degree a plus)
• 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 (FDA, EMA, etc.)
• Demonstrated experience managing project timelines, budgets, and vendor relationships
• Strong 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

Preferred Qualifications

• PMP, CCRA, or ACRP/SoCRA certification
• Experience managing multi-site or global clinical trials
• Therapeutic area expertise relevant to the organization's pipeline
• Experience working directly with CROs and central labs

Key Competencies

• Leadership and cross-functional team management
• Risk assessment and mitigation
• Attention to detail and regulatory compliance mindset
• Stakeholder communication and negotiation
• Adaptability in a fast-paced, deadline-driven environment

Organizational Expectations

All employees are expected to:

• Uphold the organization's mission, values, and commitment to ethical research.
• Protect the rights, safety, dignity, and confidentiality of research participants.
• Work respectfully with diverse communities, patients, staff, investigators, and external partners.
• Follow all applicable organizational policies, research protocols, regulatory requirements, and compliance standards.
• Maintain accurate documentation and timely communication.
• Participate in training, team meetings, quality improvement activities, and performance review processes.
• Support a culture of accountability, transparency, collaboration, and continuous learning.

Work Environment

This position may require work in a clinical, office, hybrid, or community-based setting. The role may involve interaction with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners. Some local travel, evening hours, or flexible scheduling may be required depending on study needs.

Equal Employment Opportunity Statement

The organization is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected status under applicable law.