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Senior Clinical Trial Manager (CTM)

$168k - $188k

Praxis Precision Medicines, Inc.

Location This position may be performed remotely with travel to the Boston area as needed. Position Summary This role will be responsible for project management in the initiation, execution and close out of domestic and international clinical studies, including study concept and design, feasibility assessments, study start-up, contract and budget oversight, data exchange and support of data analysis and interpretation. This position requires both the knowledge and experience to work within established clinical trial paradigms while exploring and embracing new approaches to conducting research to support data aggregation and analysis to advance patient care. The Sr. CTM will participate on clinical project teams to achieve quality results in a cost-effective and timely manner. S/he will be a key team member to establish key practices and procedures for the clinical team. Primary Responsibilities Manages study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations Manages strategic engagement with key collaborators Set-up and oversee clinical trial-related trackers such as regulatory documents, trial master file (TMF), startup progress, screening/enrollment, study invoices/payments, project budgets, etc. Regularly review documents to ensure adherence to Clinical Operations and/or project-specific quality requirements (e.g. SOPs, work practices, training guides) Education and Professional Experience Bachelor’s degree in a scientific field required; advanced scientific degree a plus 5+ years directly managing clinical trials in Sponsor or CRO setting In-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements Experienced in directing members of clinical operations teams Experience working in a team across multiple functional areas (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance) Other Essentials and Key Success Factors Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit Ability to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solve Self-motivated and able to work autonomously, as well as a member of a collaborative team Highly organized and detail-oriented with a passion to deliver quality results Strong verbal and written communication skills with an ability to build relationships internally and externally Highest level of professionalism, confidence, personal values and ethical standards Compensation

$168,000 - $188,000 USD

Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE ® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. #J-18808-Ljbffr Praxis Precision Medicines, Inc.

Vacancy posted 3 days ago
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