Clinical Trial Project Manager

**Contracted Clinical Trial Project Manager Role - 100% Remote**

Position Overview: We are looking for an experienced Clinical Trials Project Manager with 8-10 years of clinical research project management experience, specifically in oncology. The ideal candidate will have a strong understanding of oncology clinical trial operations, regulatory requirements, and project management principles.

Key Responsibilities:

Project Planning and Execution: Lead the planning, implementation, and management of oncology clinical trials, including study start-up activities, site selection, patient recruitment, data collection, and study close-out.

Cross-Functional Collaboration: Collaborate closely with cross-functional teams including clinical operations, regulatory affairs, medical affairs, data management, and biostatistics to ensure alignment of project goals and objectives.

Regulatory Compliance: Ensure compliance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company Standard Operating Procedures (SOPs) throughout the conduct of oncology clinical trials.

Budget Management: Develop and manage project budgets, track expenses, and provide regular financial updates to stakeholders to ensure financial accountability and transparency.

Risk Management: Identify potential risks and develop mitigation strategies to address challenges and minimize disruptions to project timelines and deliverables.

Vendor Management: Manage relationships with external vendors, including Contract Research Organizations (CROs), central laboratories, and other service providers, to ensure timely and high-quality deliverables.

Data Quality and Integrity: Oversee data management activities to ensure the accuracy, completeness, and integrity of clinical trial data, in compliance with regulatory requirements and data standards.

Project Reporting: Prepare and present regular project status reports, including key milestones, timelines, and issues, to project teams and senior management.

Qualifications:

Bachelor's degree in life sciences, nursing, pharmacy, or related field. Advanced degree (e.g., Master's, PhD) preferred.

8-10 years of clinical research project management experience, with a focus on oncology clinical trials.

Strong knowledge of oncology therapeutic areas, clinical trial design, and regulatory requirements (FDA, EMA, ICH-GCP) applicable to oncology clinical research.

Excellent communication, leadership, and interpersonal skills with the ability to effectively collaborate with internal and external stakeholders.

Proficiency in project management tools and software, as well as Microsoft Office Suite (Word, Excel, PowerPoint, Project).

PMP certification or equivalent project management certification is a plus.

Additional Details:

Location: Remote but preferred location on the West Coast

Duration: 16 Month Contract

Hours: Monday-Friday; Normal Business Hours; Pacific Time Zone

Start Date: Must be able to start 1st or 2nd week of June