Pulse Biosciences (Nasdaq: PLSE) is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary Nanosecond Pulsed Field Ablation (nsPFA) technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The Company is actively pursuing the development of its nsPFA technology for use in electrophysiology and the treatment of atrial fibrillation. Visit pulsebiosciences.com to learn more.

At Pulse, we:

• Exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
• Take pride in hiring the best and brightest minds to our world-class company.
• Are individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude that will excel in our culture.

About the Role

As the Clinical Trial Manager, you will primarily be responsible for working closely with cross functional teams, vendors, sites and CROs to ensure compliance with clinical study protocols. You’ll be responsible for completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identify, communicate and resolve clinical study operational issues; and participate in process improvement initiatives as necessary.

You will make an impact by:

• Managing projects with activities focused on one or more of the following: clinical operations, data management, statistics, medical writing, subject randomization and device supply management.
• Being responsible for the oversight and day-to-day operations from study startup through closeout with CROs and third-party vendors (i.e., imaging core lab, ECG core lab) to ensure that all contractual obligations are met.
• Assisting with study oversight groups such as data monitoring and adjudication committees by organizing and facilitating meetings, providing reports and documentation to committees and following upon agreed actions.
• Managing the study submission to IRB/ECs in coordination with CRO, as appropriate.
• Managing all project management aspects of assigned Phase I -IV clinical trials and in accordance to ICH/GCP guidelines, FDA, Health Canada, EMA, and other applicable regulatory and legal requirements.
• Proactively tracking and managing project tasks against timelines by creating a Smartsheet or timely minutes to alert management when there are risks of having major deviations.
• Partnering in the development of the case report form (CRF) design process including content, form layout, and edit check review.
• Developing critical study documents such as informed consent form templates.
• Managing oversight of Investigational Product (IP) accountability and ensures adequate site supply.
• Conducting and/or attending SQVs, SIVs, IMVs and COVs.
• Preparing project status reports and maintaining accurate and current details.
• Conducting “lessons learned” meetings with project team members to learn from failures and prevent same from future projects.
• Exercising sound judgment to resolve or, as appropriate, seek expert input on protocol and device questions, safety, regulatory, and legal questions. Ensuring resolution is tracked and consistently messaged to all team members and clinical sites.
• Providing support in Clinical Operations as required, such as the following:
  • Assist in the development of study-specific training materials;
  • Manage the process of setting up and maintaining the Trial Master File;
  • Review/compile documentation for qualification of clinical sites to ensure those sites comply with ICH/GCP and relevant local and global regulations;
  • Contribute to the SOP review process
• Building and mentoring clinical study team in support of business growth, as needed.

To be successful, you will bring:

• Minimum BS/BA (science or healthcare field) or equivalent experience.
• Minimum 5 years of clinical research experience as a project lead within a medical device, biotechnology or academia setting. Experience mentoring and/or managing Clinical Research Associates.
• Minimum 2 years as a clinical research associate with onsite/remote clinical monitoring experience in biotechnology/pharmaceutical/CRO industry.
• Global, registrational study experience.
• Knowledge and understanding of ICH/GCP guidelines, FDA, Health Canada, and EMA regulations.
• CCRA or CCRP certification is strongly preferred.
• Strong clinical study/project management skills.
• Proficient knowledge and skill in Acrobat Adobe, Smartsheet and Microsoft Office Suite applications with the ability to quickly become proficient in a variety of other computer software programs.
• Proficiency in clinical trial management systems including electronic data capture (EDC) software (Medidata and others), and other platform related to electronic Trial Master File (eTMF).
• Excellent communication, written and organizational skills (ability to prioritize a number of tasks of varying complexity).
• Strong knowledge of FDA regulations and willing to learn foreign regulatory requirements.
• Strong ability in problem-solving including conflict resolution.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work in a fast-paced environment with multiple competing tasks and demands, across time-zones.
• Ability to travel up 40% of the time. Overnight and/or international travel may be required.
• Ability to lift 10-15 pounds.

You’ll experience:

• Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and ESPP program.
• Paid time off, paid holidays, and flexible work schedule.
• Wellness program with free onsite gym, mindfulness classes and activities.
• A commitment to providing a respectful work environment to our diverse workforce.

Pay Range:

Exact compensation is determined based on a wide range of factors including job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range:

$120K - $160K

We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.

Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.

LOCAL CANDIDATES ONLY

Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.