Project Manager II

Role Overview

• Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOP’s, and regulatory requirements
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement
• Lead project team to ensure quality, timelines and budget management
• Accountable for the financial performance of each project
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues
• Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements
• Accountable for all project deliverables for each project assigned
• Responsible for quality and completeness of TMF for assigned projects
• Accountable for maintenance of study information on a variety of databases and systems
• Responsible for study management components of inspection readiness for all aspects of the study conduct
• Oversight for development and implementation of project plans
• Plan, coordinate and present at internal and external meetings
• Prepare project management reports for clients and management
• Developing contingency planning and risk mitigation strategies to ensure successful delivery of study goals
• Develops strong relationships with current clients to generate new and/or add-on business for the future
• May participate in bid defense meetings where presented as potential project manager
• May be required to line manage other project management team members and clinical monitoring staff

Requirements

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
• Clinical research organization (CRO) and relevant therapeutic experience preferred
• Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills
• Strong ability to manage time and work independently
• Direct therapeutic area expertise
• Ability to embrace new technologies
• Excellent communication, presentation, interpersonal skills, both written and spoken
• Ability to travel as necessary (approximately 25%)

Tech Stack

• Google Cloud Platform

Benefits

• career development and progression
• supportive and engaged line management
• technical and therapeutic area training
• peer recognition and total rewards program
• Total Self culture