Clinical Trial Manager

Position OverviewReporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related activities, timelines, actions and plans. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.Key Responsibilities:Responsible for engaging third party vendors and managing the RFP process from vendor identification through bid defense and contractingAccountable for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budgetFacilitate dose escalation meetings and the associated content and documentation enabling themAssist with the drafting of protocols, informed consent forms, study operations guidelines and other study plansWork with finance to reconcile monthly actual and forecast budgetsOversee maintenance of the eTMFPerform co-monitoring visits of clinical study sitesPlan and coordinate advisory boards, investigator meetings and CRA trainingsDevelop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progressMaintain a high standard of professionalism, and confidentiality be able to problem solve, communicate effectively, and trouble-shoot creativelyMinimum Qualifications:BS/BA/BSN - health/science related field preferredMinimum 3-5 years' relevant industry experience including at least 2 years of trial management experienceExcellent communication, writing and presentation skillsDemonstrated ability to work independently as well as in a team environment and seek resources as necessaryAbility to assess complex issues and propose viable solutionsDemonstrated ability to lead and organize team meetingsAbility to foster effective relationships with vendors, investigators and colleaguesAbility to contribute technical expertise to the various aspects of the clinical trial process.Proficiency in study monitoring activitiesKnowledge of the infrastructure and operational characteristics of CROs and centralized services.Demonstrated effective time management skillsMust be willing to travel domestically and internationally up to 15-20%Preferred QualificationsMS or advanced degree6 or more years in a Clinical Operations Management roleGlobal trial management experiencePrior Clinical Monitoring and/or CRO experienceKnowledge of First in Human trial managementExperience with dermatology indications

Created: 2025-01-15