Senior Clinical Trial Manager, Cardiac Catheter Products

Role Overview

• Work closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical trials for the 360 AF catheter ablation system.
• 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.
• Participate in process improvement initiatives.
• Lead feasibility assessments, site selection, and activation for cardiology centers capable of handling complex 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 within scope.
• 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.).
• May assist in the preparation of documents required by Clinical Study Readiness.
• May perform review and Quality Control (QC) study documents filed in the study Trial Master File (eTMF) and Investigator Site File (eISF) as needed.
• Oversee 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 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.

Requirements

• BS/BA (science or healthcare field) or equivalent experience in life sciences required.
• 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.
• 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.
• In-depth understanding of Atrial Fibrillation pathophysiology, standard-of-care treatments (ablation, cardioversion, antiarrhythmics), and complex trial designs
• 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 (domestic).
• Ability to lift 10-15 pounds.

Tech Stack

• Google Cloud Platform

Benefits

• A variety of health insurance plans and supplemental insurance options
• 401k retirement savings plan
• Paid time off
• Paid holidays
• Flexible work schedule
• Wellness program, including onsite gym and mindfulness classes
• Stock options awards
• Employee Stock Purchase Plan (ESPP) to share in our success