Clinical Trials Project Manager II - remote

ZipRecruiter; Tampa (FL); Remote; USD 72,000 - 95,000; Full time

Job summary

A leading company is seeking a Clinical Trials Project Manager II to oversee clinical operations for industry-sponsored trials. The role requires strong organizational skills and experience in project management within clinical research. You will manage project timelines, deliverables, and team training while ensuring compliance with regulations. Ideal candidates will have a background in nursing or a scientific field and at least four years of relevant experience.

Qualifications

• At least 4 years in clinical research.
• 2+ years in project/operations management.
• Knowledge of GCP, FDA, and ICH regulations.

Responsibilities

• Oversee clinical operations management activities.
• Define and monitor project scope, timelines, and deliverables.
• Manage multidisciplinary project teams.

Skills

Communication

Organizational

Leadership

Attention to detail

Education

Nursing or BA/BS in a scientific field

Tools

Microsoft Office

Job description

We are looking for a Clinical Trials Project Manager II to join our team!

APPLY DIRECTLY at https://cpcclinicalresearch.org/careers/ (internal title Clinical Operations Manager II)

Are you well organized, adaptable to unexpected changes, and able to see the bigger picture while managing day-to-day tasks? If yes, keep reading!

This role serves as the primary contact for industry-sponsored clinical trials and Endpoint and Specialty Services activities.

In this position you will:

1. Oversee clinical operations management activities.
2. Define and monitor project scope, timelines, and deliverables from initiation to close-out.
3. Identify training needs for team members and ensure completion and documentation.
4. Oversee trial-related activities and vendor payments.
5. Review and contribute to essential project documents (protocols, management plans, CRFs, etc.).
6. Develop and manage multidisciplinary project teams; organize and document meetings.
7. Ensure quality of project services and deliverables.
8. Provide updates and reports to sponsors as per contract.
9. Plan and oversee investigator meetings.
10. Collaborate with Business Development on budgets, proposals, and change orders.
11. Manage scope changes affecting finances or resources with stakeholders.
12. Support Trial Master File establishment and maintenance.
13. Adhere to applicable regulations, guidelines, and policies, documenting deviations appropriately.
14. Define and monitor scope, timelines, and deliverables for Endpoint and Specialty Services.
15. Manage external committee deliverables, including meeting logistics and documentation.
16. Oversee SAE processes and safety plan execution.
17. Track and manage source documents and data entry accuracy.
18. Provide feedback to study sites on data quality issues.
19. Manage Endpoint and Specialty Services Core Lab activities and support biostatistics and programming deliverables.

Qualifications:

• Nursing or BA/BS in a scientific field or equivalent experience.
• At least 4 years in clinical research, with 2+ years in project/operations management.
• Knowledge of GCP, FDA, and ICH regulations.
• Proficiency in Microsoft Office.
• Strong communication, organizational, and leadership skills.
• Attention to detail and ability to manage multidisciplinary teams.
• Flexibility to travel 20-25%.

Note: Candidates will need to pass background and education verification.

Targeted Compensation: $72,000 – $95,000 annually