Manager / Senior Manager, Clinical Project Management

About the role

Artivabio is seeking a dedicated and experienced Manager or Senior Manager for Clinical Project Management to join our team in San Diego, California. This role is pivotal in overseeing the planning, execution, and completion of clinical trials that are essential to our innovative gene therapies. The ideal candidate will possess a strong background in clinical project management, with a proven track record of leading cross-functional teams and ensuring compliance with regulatory standards. This position offers an exciting opportunity to contribute to groundbreaking advancements in the field of biotechnology.

Key facts

What you'll do

• Lead and manage clinical trial projects from initiation through to completion, ensuring they are delivered on time, within budget, and in compliance with regulatory requirements.
• Develop and implement project plans, timelines, and budgets, while continually assessing risks and implementing mitigation strategies.
• Collaborate closely with cross-functional teams including clinical operations, regulatory affairs, data management, and biostatistics to ensure alignment and effective communication throughout the project lifecycle.
• Oversee the selection and management of external vendors and clinical research organizations (CROs), ensuring they meet project specifications and quality standards.
• Monitor trial progress, conduct regular status meetings, and prepare comprehensive reports for stakeholders, including senior management and external partners.
• Ensure adherence to Good Clinical Practice (GCP) and other relevant regulations, maintaining the highest standards of quality and compliance throughout all clinical activities.
• Act as the primary point of contact for all clinical project-related inquiries, fostering strong relationships with internal teams and external partners.
• Identify opportunities for process improvements and implement best practices to enhance the efficiency and effectiveness of clinical project management.
• Provide mentorship and guidance to junior project management staff, fostering a culture of continuous learning and professional development within the team.
• Prepare and present project updates to senior leadership, highlighting key milestones, challenges, and strategic recommendations.
• Participate in the development of clinical study protocols and informed consent documents, ensuring clarity and compliance with regulatory standards.
• Contribute to the strategic planning of clinical development programs, aligning project objectives with overall business goals.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree (Master's or PhD) preferred.
• A minimum of 5 years of experience in clinical project management within the biotechnology or pharmaceutical industry.
• Demonstrated experience managing multiple clinical trials simultaneously, with a strong understanding of the clinical development process.
• In-depth knowledge of GCP, FDA regulations, and other relevant guidelines governing clinical research.
• Proven ability to lead cross-functional teams and manage external vendors effectively.
• Strong analytical and problem-solving skills, with the ability to make data-driven decisions.
• Excellent communication and interpersonal skills, with the ability to build relationships at all levels of the organization.
• Proficiency in project management software and tools, as well as Microsoft Office Suite.
• Strong organizational skills and attention to detail, with the ability to prioritize tasks in a fast-paced environment.

Nice to have

• Experience in gene therapy or advanced therapeutic modalities is a significant plus.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Certification in project management (PMP or equivalent) is advantageous.
• Previous experience in a start-up or fast-paced environment is desirable.

Skills & tools

• Project management methodologies and tools (e.g., Agile, Waterfall)
• Clinical trial management systems (CTMS)
• Electronic data capture (EDC) systems
• Microsoft Office Suite (Excel, Word, PowerPoint)
• Risk management frameworks

Practical notes

• This position is located in San Diego, California, and may require occasional travel to clinical sites or partner locations.
• The salary for this role is competitive and commensurate with experience, with additional benefits including health insurance, retirement plans, and opportunities for professional development.
• Artivabio is committed to fostering a diverse and inclusive workplace, and we encourage applications from individuals of all backgrounds.
• For more information and to apply, please visit our careers page at https://artivabio.bamboohr.com/careers/189.

Join Artivabio and be a part of a team that is at the forefront of transforming lives through innovative gene therapies. Your expertise in clinical project management will play a crucial role in our mission to deliver groundbreaking treatments to patients in need.