Manages a project as a project manager overseeing interdisciplinary clinical research studies
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
Leads project team to ensure quality, timelines and budget management
Accountable for the financial performance of each project
Coordinates activities and deliverables of all study conduct partners
Proactively identifies and manages issues
Ensures studies are conducted in compliance with GCP and relevant SOP’s
Accountable for all project deliverables
Responsible for quality and completeness of TMF for assigned projects
Accountable for maintenance of study information
Responsible for study management components of inspection readiness
Oversight for development and implementation of project plans
Plans, coordinates and presents at internal and external meetings
Prepares project management reports for clients and management
Develops contingency planning and risk mitigation strategies

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%)

We are passionate about developing our people, through career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition and total rewards program
Committed to building an inclusive culture – where you can authentically be yourself
Driven to Deliver, capturing the passion of our colleagues

Project Manager II

Key skills