Clinical Project Manager

Bard Electrophysiology Division is a global leader in the development of products used to diagnose and treat patients with cardiac arrhythmias. We are committed to technological innovation and to advancing the delivery of health care. Located in Lowell, Mass., we are a division of C. R. Bard, Inc., a recognized leader in the medical device industry that is currently celebrating its 100th year in business.

We're seeking a Project Manager to join our Clinical Affairs team and manage the implementation and execution of our clinical study programs. Leading the clinical core team members, the PM will have ownership of the design, planning, development and execution of all pre- and post- market clinical studies. The Project Manager works with both internal and external organizations and ensures the completion of projects on schedule and within budget in accordance with FDA, GCP and other regulatory requirements.

Additional responsibilities include:

* Develop and implement the project plan and resource requirements, coordinate and communicate project activities including project status meetings, budgets, project timelines, training, and other resources.

* Develop, plan and execute policies for clinical investigations that meet the laws and standards governing the conduct of clinical studies. Implement and monitor clinical studies in compliance with protocol, FDA regulations, GCP and Bard corporate guidelines. Coordinate the development and submission of clinical reports with Regulatory Agencies.

* Provide guidance and mentoring to the project team members. Resolves obstacles to team progress;

* Provides oversight of individual clinical trials to ensure that safety concerns and or adverse events are identified and appropriate responses are developed and executed

* Develop, review and approve protocols, CRF's, IFCs, enrollment trending, newsletters, PDOP, supply forecast, publication strategy etc. Develops all clinical study required tools including monitoring plans, data management's plans, statistical plans, and study manuals.

* Manage business expectations, and communications/data release related to project deliverables and metrics, prepares interim and final clinical study reports in collaboration with the team.

* Directs investigator recruitment and selection, conducts investigator / site training for purposes of collecting study data and study requirements. Prepares and manages site and vendor contracts and budgets, reviews all contract language in collaboration with legal.

* Lead the selection of external service providers (CROs, DSMB, CEC, etc), including contract development and negotiation of scope of work. Manage external service providers, ensuring adherence to scope of work, tracking out of scope activities

The ideal candidate will have a minimum of five (5) years experience in clinical /scientific research, nursing or medical devices/pharmaceutical clinical trials, including pre-market approval (PMA) studies; and at least three (3) years experience managing clinical projects. Additional requirements include:

* Prior clinical experience must include previous protocol design and data analysis and reporting, and demonstrated ability to execute a clinical strategy. Some experience with cardiovascular devices preferred.

* Must be knowledgeable in FDA procedures / processes, product approval pathways, and all the laws, regulations, standards, and guidelines governing the conduct of clinical studies.

* Demonstrated leadership abilities and previous management of personnel.

* Must possess strong project management skills, attention to detail, organizational skills and be highly motivated to achieve project goals. Prior experience composing clinical study reports and conducting data analysis.

* Bachelor's Degree in science or health-related field, or equivalent combination of education and experience.

* Proficiency in Windows, MS Office, and MS Project.

* Excellent communication skills, oral and written.

* Ability to travel up to 40 %

If interested, please apply online at http://track.jobviper.com/ViewJob.asp?id=497102-3-813