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.

Responsibilities

• 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
• Affirmatively 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
• 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
• Evaluate vendor invoices for completeness and accuracy
• Hire, manage, and develop internal team and contractors, as needed

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