Clinical Trial Project Manager (Medical Device)

Medpace is seeking a Clinical Trial Manager to act as project lead for full service global clinical trials for Medical Devices. We are looking for experience within Medical Devices for Metabolic, Cardiovascular, Diabetes, and more. The position interacts with sponsors and manages the timeline and all project deliverables. Are you interested in delivering effective, end-to-end collaboration, training, and resource planning around the globe to accelerate the global development of safe and effective medical therapeutics? If so, this opportunity is for you.

• Lead clinical team providing daily work direction to clinical study team members to supportneeds of clinical site, and work to meet goals and timelines of Sponsor, including determiningstudy objectives, strategy, scope, and schedule to meet Sponsor’s needs;
• Coordinate and manage project start-up, project maintenance, and project close-outactivities;
• Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact forSponsor and all project team members;
• Track study status and progress according to milestones, identify and anticipate potentialissues or challenges, and work with team to develop appropriate solutions;
• Provide project management oversight of Project Coordinators, Clinical Trial Assistants,Clinical Research Associates and other clinical study team members;
• Develop Study management tools, including communication plan, Clinical Monitoring Plan,patient recruitment and -retention plan, and other study-specific documents –andmanagement tools;
• Communicate change in scope to Sponsor clinical team and Medpace Account Manager;
• May be responsible for other projects and responsibilities as assigned; and
• Provide input on the following (as applicable):
• Study protocol/Clinical Investigation Plan
• Edit check specifications
• Data analysis plan
• Data clean-up results
• Analysis
• Final study report

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