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 CellFX nsPFA technology delivers nanosecond pulses of electrical energy to non-thermally clear cells while sparing adjacent noncellular tissue. The Company is actively pursuing the development of its CellFX nsPFA technology for use in the treatment of atrial fibrillation and in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. 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 Senior Clinical Trial Manager, you will be primarily 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 identifying, communicating and resolving clinical study operational issues; and participating in process improvement initiatives.
You will make an impact by:
- Managing the planning, execution, and completion of clinical trials.
- Maintaining detailed daily coordination and supervision of scheduled and ongoing projects.
- Managing vendors to Scope of Work (SOW), quality, and budget towards successful achievement of study goals.
- 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 regulatory submissions to (CA, IRB/ECs) according to local requirements or e-submission through the Common European Submission Portal (CESP) in coordination with or without CRO.
- 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.
- Drafting and coordinating review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures, clinical study reports and study materials (e.g., newsletters, recruitment posters, study logs, etc.).
- Developing and overseeing the production and timely distribution of site binders.
- Managing device tracking/accountability and reconciliation.
- Conducting and/or attending SQVs, SIVs, IMVs and COVs and conducting site-level training, as needed.
- Participating in surgical cases for data collection, as needed.
- Overseeing the clinical aspects of timely data cleaning and data analysis by regular review of data metrics and listings.
- Ensuring that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed as outlined in Safety Plan and/or Study Protocol.
- Providing general functional expertise to support SOP development and implementation.
- Participating in the development and management of budgets for all clinical projects and adhering to company financial goals, including working with accounting for accrual expenses of clinical affairs studies.
- Hiring, managing and developing internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.
- May perform other duties as assigned.
To be successful, you will bring:
- BS/BA (science or healthcare field) or equivalent experience in life sciences.
- 5+ years of clinical research experience including onsite monitoring.
- Multiple years’ experience planning, conducting and managing IDE clinical trials.
- Cardiac device experience with an early start-up company is a plus.
- Current ICH GCP certification is strongly preferred.
- Thorough knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical trials involving class II/III devices.
- Demonstrated ability to drive project-related activities.
- 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.
- Proficient 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).
- Ability to analyze and interpret clinical data.
- Must recognize and commit to a sense of urgency and teamwork.
- 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 to 40% of the time. Overnight and/or international travel may be required.
- Ability to lift 10-15 pounds.
You’ll experience:
- Purposeful and rewarding work collaborating with bright and curious minds!
- 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:
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: $150K - $175K.
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.
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.
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