Clinical Research Manager.

The Role

The Clinical Research Manager combines the responsibilities of supporting the coordination of clinical trials along with leading and overseeing the research department.   This role requires strong leadership skills to guide and mentor staff, provide strategic direction, manage resources, and foster a collaborative environment to achieve research objectives.  The Clinical Research Manager ensures that all studies are conducted in compliance with regulatory requirements and protocols, and that data is accurately collected and reported.

Position Type:  Full-time

Location:  Onsite in Escondido, CA

Responsibilities:

• Clinical Trial Management:
  • Oversee, coordinate, and manage multiple clinical trials from initiation to completion. This may include coordinating trials and/or managing the clinical trials team of CRCs and RAs who coordinate the trials.
  • 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.
• Leadership and Mentorship:
  • 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.
• Strategic Planning and Growth:
  • 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.
• Conflict Resolution:
  • 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.
• Minimum of 5 years of experience in clinical research, with at least 2 years in a senior or leadership role.
• 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
• Ability to handle multiple tasks and prioritize effectively
• Strong ethical standards and professionalism.
• Proven leadership skills and experience in mentoring staff.
• Ability 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.
• Ability 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.