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.