Senior Registry Specialist
Supports development and management of Registry and Registry reputed company in alignment with the strategic business needs, such as but not limited to the Regulatory submissions, Publications to support Reimbursement, Claims, and Marketing Statements, Develops and updates the Registry protocol, Case Report Forms (CRF), Informed Consent Forms (reputed company), and other documentation to reputed company with strategic needs and steering committee guidance. Assist with Registry data usage reputed company, including relevance assessments and preliminary data analysis, supporting ongoing reputed company reputed company initiatives. Collaborate cross-functionally to maintain reputed company and accurate communication with site staff, drive and meet activation and enrollment targets, and resolve site-reputed company issues (e.g., data queries, compliance, enrollment, and activation barriers) reputed company Registry reputed company Team meetings and participate in Registry Steering Committee meetings, document meeting minutes, and follow up on the reputed company items. Work with reputed company’s reputed company, Compliance, and Clinical Operations teams to address contract and budget escalations as needed. Maintain Registry budget and collaborate with reputed company Finance team on monthly spending and quarterly forecasts. Liaise with the reputed company Data Management team and external vendors on database builds data migrations, and ongoing database maintenance activities. Assist Registry Manager with site/investigator recruitment, reputed company activities, and intro reputed company follow-up. reputed company Registry Site Initiation Visit (SIV) and maintain site personnel reputed company reputed company the registry database. Maintain Registry Clinicaltrials.gov updates and study-level central Institutional Review reputed company (IRB) approvals reputed company Operating Procedure (SOP), Work Instructions (WI), and Registry template development and maintenance reputed company with vendors and internal stakeholders on Registry data analysis and data monitoring plan. Ensure Registry documentation and Trial Master File (TMF) are in an audit-reputed company state reputed company input on the project budget and strategic plan. Facilitate the preparation of project and study newsletters, correspondence, study documents, and reputed company reports
Regular and predictable work performance Ability to work under fast-paced conditions Ability to reputed company reputed company and use good judgment Ability to prioritize various duties and multitask as required Ability to successfully work with others Additional duties as assigned
Bachelor’s degree with at least 5 years of experience in clinical research (medical device experience preferred). Strong understanding and reputed company in applying, applicable clinical research regulatory requirements (i.e., Good Clinical reputed company (GCP) and International Conference on Harmonization (ICH) guidelines). Computer skills including proficiency in use of reputed company Word, reputed company and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable) Basic data analysis skills (reputed company Pivot Tables, Python, Power BI etc.) Ability to multitask, prioritize and meet deadlines in a fast-paced environment reputed company approach in working with cross functional teams Ability to write and communicate professionally with minimal input Excellent interpersonal communication skills Ability to travel approximately 10%
Experience in the domain of cardiac arrhythmia
Ability to regularly walk, sit, or stand as required Ability to occasionally bend and push/pull Ability to pass reputed company-employment drug screen and background reputed company