Project Manager

ESSENTIALDUTIES

• Leadall clinical study operations providing strategic / tactical planningorganization and direction of study project(s) including but notlimited to the oversight of clinical project timelines reportsbudgets monitoring site and vendor management clinical supplies anddata collection
• Facilitate andfoster positive productive and timely communication between Sponsorstudy team and other functionalgroups
• Manage and motivate studyteam while serving as a mentor. Mentorship may include identifyingskills of the clinical team members and assisting with furtherprofessional development
• Provideproper financial oversight of study budget including out of scopetracking
• Collaborate with seniormanagement to provide study updates / progress resourcing needssponsor issues and health status at regularly scheduled intervals(Project Review)
• Drive thedevelopment maintenance and distribution of project plans based onprojectspecific requirements throughout the life of the study (i.

e.monitoring plan communication plan project management plan eTMFplan other plans asapplicable)

• Manage studies incompliance with GCP relevant SOPs regulatory requirements andprojectspecific plans
• Assessresourcing needs to ensure the study has the appropriate resourcesfor the duration of theproject
• Actively manage and trackstudy risks (with team and Sponsor input for potential obstaclesthat would delay the project s progress while appropriatelyescalating issues
• Assess trainingneeds of team members on the therapeutic area protocol specialprocedures / skills and implement the appropriate trainingplans
• Delegate study teamresponsibilities and ensure that team members have the necessarytools and resources to effectively perform theirrole
• Monitor and manage the projects progress and develop timelines with input from relevantstakeholders and sponsor approval;

reassess critical path for studyprogress and adjust timelines asneeded

Oversee activities anddeliverables of outside vendors as requested; ensure communicationoccurs between outside vendors the team andsponsor

OTHERQUALIFICATIONS

• Outstandinginterpersonal oral and written communicationskills
• Proven effectiveness as ateam leader
• Prior experiencesuccessfully managing multifaceted studies from inception throughimplementation andcompletion
• Outstandingorganizational and time managementskills
• Experience managing projectsin a virtualenvironment
• Demonstrated ability tolead by example and to encourage team members to seek solutionsindependently

Requirements

RNor Bachelor and / or advanced degree in biological sciences orrelated field or equivalent combination of relevant experienceeducation or training and previous CRAexperience

Benefits

• Competitivepay
• Careergrowth
• Full medical dental andvision benefitpackages
• 401(k)
• Commuterbenefits
• Legalbenefits
• The best coworkers if we dosay soourselves

RN or Bachelor and / or advanced degree in biological sciences orrelated field, or equivalent combination of relevant experience,education or training and previous CRA experience