Study Manager - Infectious Disease

Overview

Manage interdisciplinary clinical research studies as project manager, serving as primary liaison between the Company and the Customer to ensure compliant, on-time, on-budget study delivery.

What you'll do

• Manage a project as a project manager overseeing interdisciplinary clinical research studies and ensure compliance with GCP, relevant SOPs, and regulatory requirements.
• Act as the 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 the project team to ensure quality, timelines and budget management, and be accountable for the financial performance of each project.
• Coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Be accountable for all project deliverables for each project assigned.
• Be responsible for quality and completeness of the TMF for assigned projects.
• Be accountable for maintenance of study information on a variety of databases and systems.
• Be responsible for study management components of inspection readiness for all aspects of study conduct.
• Oversee development and implementation of project plans.
• Plan, coordinate and present at internal and external meetings.
• Prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add-on business.
• 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.

What you'll need

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

Nice to have

• Clinical research organization (CRO) and relevant therapeutic experience.
• Direct therapeutic area expertise.

Details

• Location: USA, remote.
• Travel: approximately 25%.
• Employment is subject to the posting being a possible upcoming opportunity rather than a live role.