Project Manager Clinical Trials

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.

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