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Transcend Therapeutics · 2 months ago

Associate Director, Clinical Operations

New York, NY

Full-time

Onsite

Senior Level, Lead/Staff, Director/Executive

$180K/yr - $210K/yr

7+ years exp

Transcend Therapeutics is a late-clinical-stage neuroscience company focused on developing treatments for neuropsychiatric diseases. The Associate Director, Clinical Operations will oversee the execution of clinical trials, driving operational strategy and ensuring compliance with regulatory guidelines while managing a team and collaborating cross-functionally.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Support the Clinical Trial Manager with planning and strategy for implementation and execution of assigned clinical trials from study startup through close-out

Oversee day-to-day operations of assigned clinical trials including team interactions with study sites and vendors and act as an escalation point for key issues

Identify, prepare, and implement departmental process improvement initiatives to improve operational efficiencies

Provide expertise for drafting, finalization and implementation of clinical documents (ie, Protocol, Clinical Monitoring Plan)

Oversee various activities and cross-functional collaboration of assigned clinical trials (e.g., monitoring, data management, drug supply logistics, labs, recruitment)

Manage direct report(s) by providing leadership, vision and mentoring

Proactively identify clinical data trends and escalate as needed

Ensure Trial Master File (TMF) maintains regulatory compliance

Support creation, review, and revision of clinical SOPs

Ensure that the clinical trials are conducted in a timely fashion and in compliance with SOPs, GCP, regulatory guidelines, company goals, and budget

All other duties as required

Qualification

Clinical trial managementGCP/ICH knowledgeDrug development processPsychiatry-related studiesClinical monitoring experienceFlexibleLeadershipCommunication skillsDetail-orientedInitiative