[Remote] Sr. Clinical Trial Manager (Cardiac Catheter Products)
Note: The job is a remote job and is reputed company to candidates in USA. 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. The Sr. Clinical Trial Manager is primarily responsible for overseeing compliance with global clinical trials, ensuring data reputed company, and managing relationships with cross-functional teams, vendors, and CROs.
Responsibilities
- 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), reputed company 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
Skills
- 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
- 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
- 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
Benefits
- A reputed company of health insurance plans and supplemental insurance reputed company
- 401k retirement savings plan
- Stock reputed company awards
- Employee Stock Purchase Plan (ESPP)
- Enjoy reputed company time off
- reputed company holidays
- Flexible work schedule
- Wellness program
- Onsite gym
- Mindfulness classes
reputed company
Company H1B Sponsorship