Project Manager Clinical Trials at VIDA Diagnostics Inc

VIDA is seeking a Clinical Trial Project Manager to act as project lead for global clinical trials using medical imaging. The position interacts with sponsors, CROs and trial sites and manages the timeline and all project deliverables. Are you interested in delivering effective, end-to-end collaboration, project management, and resource planning to accelerate the global development of safe and effective medical therapeutics? If so, this opportunity is for you.

Responsibilities:

• Work cross-functionally at VIDA to support needs of clinical site, and work to meet goals and timelines of Sponsor, including ensuring imaging study objectives, deliverables and schedule meet Sponsors needs;
• Coordinate and manage project start-up, project maintenance, and project close-out activities;
• Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members;
• Track study status and progress according to milestones, identify and anticipate potential issues/risks or challenges, and work with team to develop appropriate solutions;
• Develop trial management charter, including defining KPIs, scheduling and resource plan, risk management plan, communication plan, and other study-specific documents and management tools;
• Assess impact of change in scope, and communicate to Sponsor clinical team and VIDA team members;
• Accurately report on project status/metrics both for status and as input to finance for invoicing purposes
• May be responsible for other projects and responsibilities as assigned; and

Qualifications

• Bachelors degree in Life Sciences or related field and a minimum of 3 years of related imaging or medical device industry experience (i.e. project management), or Masters degree in Life Sciences or related field and minimum 2 years related imaging or medical device industry experience
• Prior experience with clinical trials is preferred;
• Experience working at or with CROs is preferred;
• Exceptional communication skills (oral and written);
• High attention to detail and quality standard;
• Strong time and project management skills;
• Strong risk management skills;
• Working knowledge of Good Clinical Practice for clinical trials in the US (21 CFR 812 and other sections) and/or Europe (ISO 14155), and local regulations is preferred; and
• Proficient with all Microsoft Office applications (Word, Excel, Power Point, Project, etc.).

All VIDA employees expected to be flexible and have an entrepreneurial mindset. Other duties may be assigned as needed.