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

Requirements

Bachelor’s degree, preferably in a life science
At least 7 years of clinical trial experience within a pharmaceutical company or CRO and at least 4 years in a managerial position
Experience managing direct reports
Proficient knowledge of GCP/ICH, drug development process, clinical operations
Experience executing clinical trials in a small team or at a small pharmaceutical company is preferred
Experience conducting studies in psychiatry-related indications is preferred
Previous clinical monitoring experience is preferred

Benefits

medical, dental, and vision insurance
401k
unlimited vacation and sick time
competitive cash and equity compensation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementclinical document draftingdata managementprocess improvementregulatory complianceclinical monitoringdrug development processSOP creation and revisionclinical operationsdata trend analysis

Soft Skills

leadershipmentoringstrategic planningproblem-solvingcross-functional collaborationcommunicationteam managementoperational efficiencyescalation managementvision