Clinical Research Manager

Responsibilities

• Oversee, coordinate, and manage multiple clinical trials from initiation to completion.
• Ensure compliance with research protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Recruit, enroll, and manage study participants throughout the entire study.
• Obtain informed consent from participants and ensure their understanding of the study, collect data using Good Documentation Practices, maintain accurate and up-to-date records of study activities.
• Communicate with study sponsors, regulatory bodies, and other stakeholders.
• Prepare and submit regulatory documents as required.
• Ensure proper storage and handling of study specimens and investigational products.
• Lead and mentor junior research staff, providing guidance and support until mastery in needed skills is demonstrated.
• Foster a collaborative and productive work environment that encourages continuous improvement.
• Lead regular team meetings to discuss status of current projects, plan for future projects, provide updates on new company initiatives, seek feedback regarding team barriers, etc.
• Manage local team to meet/exceed quality and performance metrics, report key performance indicators to leadership team.
• Serve as a Culture Champion to support our mission and values, ensure team is compliant with SOPs and all industry standards.
• Develop and implement strategic plans for clinical research projects, allocate studies to the team based on bandwidth and teammate skillset.
• Drive the growth and development of the clinical research program by identifying areas for improvement and innovation while staying informed of industry advancements.
• Proactively identify/anticipate risks (strategically, operational, financial, regulatory, and reputational) that could hinder achievement of business goals.
• Address and resolve conflicts within the research team and with external stakeholders.
• Mediate disputes and facilitate effective communication.
• Implement strategies to prevent and manage conflicts.

Requirements

• Bachelor's degree in a scientific, health-related, or business administration field. Advanced degree (e.g., Master's, PhD) is preferred.
• Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is preferred.
• Knowledge of project management principles and methodologies.
• Strong organizational and time-management skills.
• Excellent communication and interpersonal skills.
• Attention to detail and ability to work independently.
• Problem-solving and critical thinking abilities.
• Able to handle multiple tasks and prioritize effectively.
• Strong ethical standards and professionalism.
• Proven leadership skills and experience in mentoring staff.
• Able to inspire and motivate a team.
• Strategic thinking and planning abilities.
• Growth mindset and a commitment to continuous improvement.
• Strong conflict resolution and mediation skills.
• Able to manage and resolve disputes effectively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Familiarity with Electronic Data Capture (EDC) systems and clinical trial management software.

Pay

California Pay Range $100,000 - $105,000 USD