Senior Associate, Clinical Operations - New York - Transcend Therapeutics

    Transcend Therapeutics
    Transcend Therapeutics New York

    2 days ago

    Description
    Position Details
    • Title: Senior Associate, Clinical Operations
    • Location: New York City
    Company Overview
    Founded in 2021, Transcend Therapeutics is a late-clinical-stage neuroscience company developing rapid-acting treatments for neuropsychiatric diseases. Our lead asset TSND-201, a rapid-acting neuroplastogen, is the first and only product to demonstrate rapid, robust, and durable therapeutic effects in PTSD. TSND-201 was granted Breakthrough Therapy designation by the FDA based on Phase 2 results, and we have aligned on a Phase 3 program for TSND-201 in PTSD. Transcend is backed by leading life sciences investors and driven by a mission to create treatments for the millions of people for whom current psychiatric medicines have not worked.
    About the Role
    The Senior Associate, Clinical Operations is a key member of the Clinical Operations team, with responsibility for supporting the operational aspects of one or more clinical trials. The Senior Associate will support the Clinical Trial Manager, CRAs, and the investigational sites.
    This position is highly visible in a small, growing organization which may provide for the opportunity for rapid advancement.
    Key responsibilities will include:
    • Assist clinical team during all phases of a clinical study (feasibility, start-up, maintenance, and close-out)
    • Support field-based clinical research associates
    • Participate in vendor and study team meetings, including drafting meeting minutes, as needed
    • Collect and review essential regulatory documents
    • Submission and tracking of documents to central IRB
    • Distribute materials to study sites, as directed
    • Create and maintain study trackers (e.g., contact lists, study status trackers, enrollment)
    • Review and maintain documents in the Trial Master File (TMF)
    • Support internal data review, as needed
    • Participate in creation, review, and revision of clinical SOPs
    • Assist in preparation and coordination of Investigator Meetings, as needed
    • Additional responsibilities as required
    This is a great opportunity to step into a high-impact, high-visibility role on the early team of Transcend Therapeutics. We offer competitive cash and equity compensation; medical, dental, and vision insurance; 401k; unlimited vacation and sick time; and more.
    The salary range for this role is $70,000 to $100,000, plus equity and benefits.
    Experience Requirements
    • At least 1 year of clinical research experience within a pharmaceutical company or CRO or at least 3 years of experience as a clinical research coordinator
    • Experience in conducting studies in psychiatry-related indications is preferred
    • Proficient knowledge of GCP/ICH, drug development process, clinical operations
    Key Competency Requirements
    • Excellent verbal, written, communication and interpersonal skills
    • Detail-oriented, with a desire to 'get in the weeds' and understand the nuances
    • Flexible, able to pivot when needed in a fast-paced environment
    • Able to effectively communicate and collaborate across functions and job levels
    • Internally motivated, with a passion for mental health
    • Routinely takes initiative
    Travel Required
    • Domestic and international travel may be required (approximately 5%)
    We are committed to building a diverse, inclusive and talented team, free from discrimination. If you're excited about our mission but don't meet 100% of the qualifications above, we encourage you to apply.
    Transcend Values
    Operate with good intent. Above all, we aim to reduce suffering. We must remain selfless in pursuit of that noble goal, acting with good intent and assuming the same in our partners and peers.
    Proceed with Passion. We're working to usher in an era where people with mental illness have safe and easy access to the treatments they need. Fulfilling that mission demands creative ideas, camaraderie among collaborators, and an understanding that we are all responsible for our individual and team success.
    Be willing to work-and learn-together. The problems we're working to solve are complex, and no one person has every solution. Making the best decision as a team is more important than being individually "right." The diversity of our backgrounds and experiences is a strength; when all of those views are synthesized, we can develop new solutions and make better decisions.

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