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.

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
We are committed to building an inclusive culture – where you can authentically be yourself.

Project Manager II – Early Phase, Sponsor Dedicated

Key skills