Sr. Clinical Trial Manager (Cardiac Catheter Products)

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 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:

• 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.

To Excel, You Will Bring: 

• 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.