Senior Clinical Trial Manager (CTM)

Senior Clinical Trial Manager (CTM)United States - RemoteSenior Clinical Trial Manager (CTM)This position may be performed remotely with travel to the Boston area as needed.Position SummaryThis 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 ResponsibilitiesManage 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 regulationsManage strategic engagement with key collaboratorsSet-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.Key contributor to IRB/EC and regulatory submissionsOversee TMF reviews to ensure completeness and inspection readinessRegularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides)Identify and mitigate against study risks, escalating as necessaryDirect initiatives to identify and implement best practices and continuous improvement plans in clinical developmentEducation and Professional ExperienceBachelor's degree in a scientific field required; advanced scientific degree a plus5+ years directly managing clinical trials in Sponsor or CRO settingIn-depth knowledge of clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirementsExperience directing members of clinical operations teamsExperience 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 FactorsIntellectual curiosity, innovation and creative problem solving with an entrepreneurial spiritAbility to think critically in fast-paced projects with a keen sense of urgency and demonstrated ability to problem solveSelf-motivated and able to work autonomously, as well as a member of a collaborative teamHighly-organized and detail-oriented with a passion to deliver quality resultsStrong verbal and written communication skills with an ability to build relationships internally and externallyHighest levels of professionalism, confidence, personal values and ethical standardsAnnualized Base Salary$168,000 - $188,000 USDCompensation & BenefitsAt Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together!Company OverviewPraxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. 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.Attention: Job Scam AlertPraxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to View email address on click.appcast.io.