Pulse Biosciences, Inc.

Pulse Biosciences, Inc.

Sr. Clinical Trial Manager (Cardiac Catheter Products)

US Remote · Senior

Sponsorship not specified$10k-$15kDetected 14 days ago
GCPData AnalysisExcelProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryMedical DevicesResearchCommunicationProblem SolvingOrganizational SkillsMicrosoft Office

About the role

  • Clinical Trial Manager is primarily responsible for working closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical trials for the 360 AF catheter ablation system.
  • 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

Responsibilities

  • 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.
  • 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.
  • 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.

Requirements

  • May assist in the preparation of documents required by Clinical Study Readiness.

Nice to have

  • Cardiac electrophysiology 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.
  • 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.

Compensation

  • $10k-$15k

Benefits

  • Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.
  • 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.
  • Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
  • Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.

Company info

  • 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.
  • A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
  • 7+ years of clinical research with medical device experience including onsite monitoring and oversight of CRAs with a medical device company or medical device CRO.
  • At Pulse Biosciences, we are driven by purpose and innovation.

Equal opportunity

  • A commitment to providing a respectful work environment to our diverse workforce.
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