Sr Clinical Data Manager

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description To provide oversight for end-to-end Data Management activities, manage data currency throughout the trial, and overall monitoring Data management deliverables for all phases of clinical trials for Medical Devices. Responsibilities, Skills & Hands-On Experience Develop and design CRF for a clinical trial, including pre-market feasibility and pivotal trials for medical devices. Development of the Electronic Data Capture (EDC) Database in compliance with 21 CFR part 11 and GDPR, including the requirements specifications, edit checks, programming for the database build, user acceptance testing requirements, and database validation documentation. Integration of required functionalities such as imaging video repository, site payments, ePro, eConsent, safety/CEC adjudications, as applicable. Setup and review data tracking reports to optimize data management processes for data integrity. Ensures The Accuracy and Consistency of Clinical Databases. Reviewing data and identifying errors/inconsistencies. Collaborating with appropriate project team to prevent and resolve data issues. Tracking outstanding issues and following-up until resolution. Preparing and validating study metrics and ad hoc data listings as necessary. Develop and maintain appropriate clinical data management documentation including but not limited to Data Management Plan, Data Quality Review Plan, User Acceptance Testing Plan, CRF Completion Guidelines (CCGs), document change control logs, training requirements and records. Facilitate Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality, and completeness. Meet milestone events such as database go-live, interim database freeze, database locks, and DSMB reviews. Complete projects and tasks in a manner consistent with corporate goals and objectives. Support Clinical Operations to evaluate EDC vendors, and system functionality requirements for the study, as needed. Represent Data Management on cross-functional project. Support the system vendor selection process to assess system capabilities with study team needs. Program periodic study reports and training materials upon request. Maintenance of the EDC database throughout the study including mid-study changes. Participate in the Health Authority inspections and audits. Collaborate in the development of data management SOPs and Work Instructions. Strong attention to detail and skill with numbers. Strong analytical/problem-solving skills. Must have the ability to work with limited supervision in a remote setting. Strong project management; Exhibits expertise in metrics analysis and reporting methodologies. Excellent oral and written communication skills. Demonstrated ability to communicate effectively with senior management and cross-functional teams. Education & Work Experience BA degree preferably in the computer sciences, or related discipline. Years of relevant clinical data management experience using multiple EDC platforms may substitute for degree in some cases. 6+ years in a CDM department in a device, biopharmaceutical or CRO setting. Strong knowledge and experience of EDC systems (e.g., iMednet, Medrio, and other EDC platforms), IRT, CTMS, eTMF, and ePRO preferred. Demonstrated knowledge of Microsoft Office Suite. Well versed in industry trends and emerging technologies supporting data collection. Knowledge of FDA submission requirements, e.g., Investigational Device Exemption (IDE) . Working knowledge of regulatory requirements such as ISO 14155, FDA regulations (CFR 11, 50, 54, 56, 812) and ICH Good Clinical Practice (required). Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider current market rate, and title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $130,000 to $150,000+ equity + benefits. NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to .