Sr. Clinical Trials Manager

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 150,000 - 175,000; Full time

Job summary

Pulse Biosciences, Inc. is seeking a Sr. Clinical Trials Manager to oversee global clinical feasibility trials. The ideal candidate will have extensive experience in clinical research, particularly with medical devices, and a strong understanding of regulatory compliance. This role offers a unique opportunity to contribute to innovative bioelectric medicine solutions, ensuring high-quality data and operational excellence.

Benefits

Comprehensive Benefits

Stock Options

Flexible Work Schedule

Onsite Gym

Paid Time Off

Qualifications

• 5+ years of clinical research experience, particularly with medical devices.
• Experience in managing clinical trials and vendor relationships.
• Knowledge of FDA and EMA regulations.

Responsibilities

• Manage global clinical feasibility trials ensuring compliance and data quality.
• Coordinate with vendors and internal teams for project execution.
• Assist in regulatory submissions and maintain project timelines.

Skills

Clinical Research

Project Management

Regulatory Compliance

Education

BS/BA in Science or Healthcare

ICH GCP Certification

Job description

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Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine

Pulse Biosciences 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 (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously 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.

Why Join Us?

At Pulse Biosciences, we are driven by purpose and innovation.

• Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
• Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
• Our Commitment: Hiring the best and brightest minds to advance our world-class organization.
  
  

What You Will Experience

• Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
• Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
• Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
• Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.
  
  

About The Role

The Sr. Clinical Trial Manager is primarily responsible for working closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical feasibility trials. S/he is responsible for completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives.

To Make An Impact, You Will

• Contribute to the planning, execution, and completion of global clinical feasibility trials.
• Assist in the preparation of documents required for Clinical Study Readiness.
• Attend and participate in Company Project Teams.
• Maintain detailed daily coordination and supervision of scheduled and ongoing projects.
• Manage vendors to Scope of Work (SOW), quality, and budget towards successful achievement of study goals.
• Assist in managing Core Labs by organizing and facilitating meetings as required, reviewing guidelines and tracking standard reports in the portal.
• Assist in 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 track and manage project tasks against timelines by creating a Smartsheet or timely minutes to alert management when there are risks of having major deviations.
• Draft and coordinate review of relevant documents including informed consents, source documents for data entry, power-point slide deck for site initiation visit, monitoring plans, clinical study and/or safety reports and study materials (e.g., newsletters, recruitment posters, study logs, etc.).
• Develop and oversee the production and timely distribution of site and regulatory binders as needed.
• Perform initial Review and Quality Control (QC) study documents filed in the study Trial Master File (eTMF) and Investigator Site File (eISF).
• Manage device tracking/accountability and reconciliation at participating centers.
• May conduct and/or attend SQVs, SIVs, IMVs and COVs and conduct site-level training, as needed.
• Participate in CellFX clinical study cases for data collection, as needed.
• Perform User Acceptance Testing (UAT) in database for initial and ongoing eCRF development and contribute to the review of EDC guidelines.
• Oversee the clinical aspects of timely data cleaning and data analysis by regular review of data metrics and listings.
• Ensure that device or procedure related adverse events are identified and appropriate responses to such concerns are developed and executed as outlined in Safety Plan and/or Study Protocol.
• Must have general functional expertise to support SOP development and implementation.
• Evaluate vendor invoices for completeness and accuracy.
• Hire, manage and develop internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.
  
  

To Excel, You Will Bring

• BS/BA (science or healthcare field) or equivalent experience in life sciences required.
• 5+ years of clinical research with medical device experience including onsite monitoring and oversight of CRAs with a medical device company or medical device CRO.
• International clinical trial experience is a plus.
• Cardiac device experience with an early start up company is a plus.
• Current ICH GCP certification is strongly preferred.
• Thorough knowledge of FDA and EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical trials involving class II/III devices.
  
  

Pay Range

Compensation is determined based on a wide range of factors including location, 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

Ready to Shape the Future of Healthcare?

Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.

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.

PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Medical Equipment Manufacturing

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