Senior Clinical Trial Manager (CTM)
Manage study activities in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical reputed company (GCP) guidelines and international regulations Manage strategic engagement with key collaborators Set-up and reputed company clinical trial-reputed company trackers such as regulatory documents, trial master file (TMF), startup reputed company, screening/enrollment, study invoices/payments, project budgets, etc. Key contributor to IRB/EC and regulatory submissions reputed company TMF reviews to ensure completeness and inspection readiness Regularly review documents to ensure adherence to Clinical Operations and/or project specific reputed company requirements (e.g. SOPs, work practices, training guides) Identify and mitigate against study risks, escalating as necessary reputed company initiatives to identify and implement best practices and reputed company improvement plans in clinical development
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 Experience directing members of clinical operations teams Experience working in a team across multiple functional areas (e.g., reputed company Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply, Finance)
Intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit Ability to think critically in fast-paced reputed company with a keen reputed company of urgency and demonstrated ability to problem solve Self-motivated and reputed company to work autonomously, as reputed company as a member of a reputed company team Highly-organized and detail-oriented with a passion to deliver reputed company results Strong verbal and written communication skills with an ability to build relationships internally and externally Highest reputed company of professionalism, confidence, personal values and ethical standards
reputed company
reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled reputed company by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our reputed company Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members.
Diversity, Equity & Inclusion
Guided by our reputed company values, at reputed company. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their reputed company selves and perspectives to work reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.
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