Clinical Project Manager

Regulatory      ·      Fremont, CA       ·      Full time

Job Description:

Development, implementation, and execution of Neuralink’s human clinical trial operations. Build and manage key relationships between internal Neuralink teams, and external organizations such as study sites, research partners, regulatory bodies, and other entities essential to successfully carrying out human clinical trials.

About you

• Meticulous attention to detail and strong organizational skills
• Effective multitasking skills
• Great verbal and written communication skills
• Driven to see projects through to completion
• Resourceful, flexible, and adaptable; no task is too big or too small
• Ability to thrive in a dynamic and constantly changing environment
• Ability to work effectively and collaboratively in a cross-disciplinary team environment
• Willing and eager to go above and beyond/flexible schedule

Key Responsibilities

• Project management and task management
• Creation and review of clinical trial components, SOPs, participant-facing materials, and study plans
• Negotiating and building relationships with organizations
• Management and oversight of external vendors
• Operationalizing clinical trials
• Work collaboratively and effectively with external partners, clinical staff, and Neuralink team. 
• Organize study data collection pipelines
• Maintain a working knowledge of and assure compliance with Good Clinical Practices, Federal Regulatory requirements, and Site Specific SOPs.

Key Qualifications

• Evidence of exceptional ability in science or engineering 
• 3+ years biomedical-related research
• 2+ years of academic or industry experience working with medical devices.
• Prior experience executing clinical trials
• Comfortable working closely with physicians, engineers, participants, and technical staff in a research and healthcare environment. 
• Working knowledge of FDA reporting regulations related to clinical studies. 
• Comfortable in the operating room environment.
• Working knowledge of medical and scientific terminology.
• Demonstrated communication and management skills.
• Demonstrated problem-solving abilities in managing clinical sites and demonstrated tactfulness and diplomacy in communicating with study staff.

Preferred Qualifications 

• Thorough knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations
• Working knowledge of FDA reporting regulations related to clinical studies
• Prior experience with neurological or spinal medical devices
• 3+ prior publications in biomedical engineering or neuroscience
• Familiarity with scripting or programming

What we offer:

• An opportunity to change the world and work with some of the smartest and the most talented experts from different fields. 
• Growth potential. We rapidly advance team members who have an outsized impact. 
• Excellent medical, dental, and vision insurance through a PPO plan; parental leave.
• Flexible time off + paid holidays.
• Equity + 401(k) plan.
• Commuter Benefits.
• Meals provided.

Neuralink provides equal opportunity in all of our employment practices to all qualified employees and applicants without regard to race, color, religion, gender, national origin, age, disability, marital status, military status, genetic information or any other category protected by federal, state and local laws.  This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social, and recreational programs. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.