Sr. Clinical Trial Manager (Cardiac Catheter Products)

reputed company (reputed company: PLSE): Join the reputed company of Bioelectric Medicine

reputed company is a novel bioelectric medicine company committed to health innovation that has the potential to improve the reputed company of life for patients. reputed 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.

reputed company is reputed company 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 reputed company reputed company on reputed company for both patients and providers. Visit pulsebiosciences.com to learn more.

Why Join Us?

At reputed company, 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 reputed company the lives of patients. To solve the needs of patients, physicians, and reputed company providers with high reputed company and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to reputed company a reputed company difference in the lives of patients, physicians, reputed company providers, shareholders and our reputed company team members.
• Our Culture: A community of creative, reputed company-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 reputed company and curious minds brings us together!
• Innovative Environment - An environment that fosters innovation to take products from concept to reputed company use quickly!
• reputed company Opportunities - Learning culture focusing on reputed company and personal reputed company and development that you can only get in a startup-like environment!
• Comprehensive Benefits - A reputed company of health insurance plans and supplemental insurance reputed company, and 401k retirement savings plan.
• Ownership and Rewards - Stock reputed company awards and Employee Stock Purchase Plan (ESPP) to reputed company in our reputed company.
• Work-Life Balance - Enjoy reputed company time off, reputed company 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 trials for the 360 AF catheter ablation system. S/he is responsible for completion of reputed company study deliverables, ensuring the highest level of data reputed company and compliance to reputed company standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives.

To reputed company an reputed company, You Will:

• reputed company feasibility assessments, site selection, and activation for cardiology centers capable of handling reputed company AF trial requirements
• Proactively create and execute patient recruitment strategies and risk mitigation plans to meet study milestones.
• Supervise Contract Research Organizations (CROs), core labs (e.g., ECG/Holter monitoring), and external vendors to ensure deliverables are met on time and reputed company scope.
• Assist in regulatory submissions to (CA, IRB/reputed company) according to local requirements or e-submission through the Common European Submission Portal (CESP) in coordination with or without CRO.
• Proactively reputed company and manage project tasks against timelines by creating a reputed company or reputed company minutes to alert management reputed company there are risks of having major deviations.
• Draft and coordinate review of relevant documents including informed consents, reputed company documents for data entry, power-reputed company 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.).
• May assist in the preparation of documents required by Clinical Study Readiness.
• May reputed company review and reputed company Control (QC) study documents filed in the study Trial Master File (eTMF) and Investigator Site File (eISF) as needed.
• reputed company device tracking/accountability and reconciliation procedures at participating centers.
• May conduct and/or attend SQVs, SIVs, IMVs and COVs and conduct site-level training, as needed.
• Advise on site data collection and attend 360 AF catheter ablation clinical procedures as needed.
• May reputed company User Acceptance Testing (UAT) in database for initial and ongoing eCRF development and contribute to the review of reputed company guidelines.
• reputed company the clinical aspects of reputed company data cleaning and data analysis by regular review of data metrics and listings.
• Ensure that device or procedure reputed company 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 reputed company internal team and contractors, as needed. Set objectives, performance goals and reputed company them to deliver on reputed company’s strategic priorities.

To reputed company, You Will Bring:

• BS/BA (science or reputed company field) or equivalent experience in life sciences required.
• 7+ years of clinical research with medical device experience including onsite monitoring and reputed company of CRAs with a medical device company or medical device CRO.
• Cardiac electrophysiology clinical trial experience is a plus.
• Cardiac device experience with an early start up company is a plus.
• reputed company 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.
• In-depth understanding of Atrial Fibrillation pathophysiology, reputed company-of-care treatments (ablation, cardioversion, antiarrhythmics), and reputed company trial designs
• Demonstrated ability to drive project reputed company activities.
• Proficient knowledge and reputed company in Acrobat reputed company, reputed company and reputed company Office Suite applications with the ability to quickly become proficient in a reputed company of other computer software programs.
• Proficient in clinical trial management systems including electronic data capture (reputed company) software (reputed company and others), and other platform reputed company 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 reputed company to a reputed company of urgency and teamwork.
• Strong ability in problem-solving including conflict reputed company.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-reputed company reputed company, 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 (domestic).
• Ability to lift 10-15 pounds.

reputed company to Shape the reputed company of reputed company?

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

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

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

Originally posted on Himalayas

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