- 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.
- 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.
- 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
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Clinical Trial Project Manager - California, United States - Medix™
Description
**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:
Qualifications:
Additional Details:
