Clincial Project Manger : Medical Devices : Mass

Execute an exciting clinical trial from the ground up for a technology that could change the treatment pattern for cardiac patients!

Utilize strategic planning skills to determinestudy objectives, strategy, scope, budget and schedule to meet the goals and timelines of trials in multiple therapeutic areas.

Project Management

Provides highly effective clinical project management for the life cycle of one (or more) complex project(s). Monitor and drive the progress of the clinical study. Provide dotted line management of clinical study associates and team members. Identify and react to potential risk and challenges and develop proactive solutions. Forecast and budget for the clinical study. Ensure compliance to all national and international regulations, audits, deliverable timelines of trials. Prepares and presents status updates to Boards, Panels, Management and Clients

Medical Writing

Prepares investigational site lists and participates in reviewing and approving; ensuring documentation, site inspection , monitoring, relationship development and audit ready compliance throughout lifecycle of the trial

Other Required Skills

Bachelor's degree in Life Sciences or a related field;

At least 7 years of clinical study experience, including prior experience with medical devices and IDE trials;

Previous knowledge of GCP for medical device trials, 21 CFR 812 (other sections, depending on role);

Outstanding oral and written communication skills;

Ability to interact with medical personnel and attend medical procedures;

Strong customer service focus and project management skills;

High attention to detail and quality standard; and

Proficient in Microsoft Office applicationsTo find out more about Real Staffing please visit www.realstaffing.com