Manager Clinical Programs Medical Device AZ

Our client is a global leader in developing, manufacturing, and marketing of innovative medical devices in the fields of Vascular, Urology, Oncology, and Surgical products. We are pleased to be involved with the search for an outstanding candidate for the challenging and exciting Clinical Program Manager for our client dedicated to pursuing technological innovations at reduced overall costs that offer superior clinical benefits

Clinical Program Manager-Medical Devices

Responsibilities:

• Supervisory responsibilities for direct reports, hiring, performance, salaries development, training.
• Schedules, supervises and ensures the delivery of services provided by internal and external teams (feasibility, documentation, resources, status
• Coordinates the development, follow up and submission of clinical reports to Regulatory Affairs / FDA
Ensures that the project teams fulfill their responsibilities in accordance with the scope of work and project plan
• Oversees, mentors and reviews work product produced by project team members
and vendors are in compliance with agreement (e.g. project deliverables, timelines)
• Ensures that projects are delivered on time, within budget, and according to requirements and expectations and with regard to GCP-ICH guidelines, applicable regulations and performance metrics
• Interacts with internal and external project teams to assure comprehensive management of program regarding risk assessment and escalates to management if there is significant business impact
• Assists in the development and implementation of standardized processes and operating procedures for conducting clinical research with development of the study protocol/ case report forms, investigators brochure, clinical instructions for use and clinical reports
• Interacts with investigative sites, vendors and other functional areas as primary project contact for clinical issues and to ensure compliance with the study protocol, ICH-GCP guidelines and all applicable regulations
• Supervises investigational product accountability, subject screening/enrollment, case report form monitoring/retrieval, all clinical events are reported appropriately
• Documents and reports non-compliance issues in a timely manner

Requirements
• Master's, Bachelor's degree or Technical degree defined as biological sciences or related medical/scientific field
• 5-8 years of medical device / research industry management and/or Senior CRA experience with 3 years of supervisory experience
• Minimum of 3 years of site monitoring experience
• Functions well individually as well as participating in and leading a cross-functional team environment in the technical and supervisory capacities
• Demonstrated project and people management skills including, including management of projects and multiple vendors
• Experience with clinical audit requirements and ability to prepare/participate in FDA audits and regulations (FDA/CFR, ICH/GCP)
• Willing to travel up to 40%
• Excellent analytical, negotiation and communication (computer, verbal and written) skills

Excellent Salary, Benefits and Relocation for this exceptional opportunity!
Shore Consultants is the fastest growing most comprehensive Pharmaceutical /Medical Device Recruiting Firm within the MRI Network. Why? We deliver over and over and over; one quality placement at a time. MRI is the largest search and recruitment organization in the world today. Come and see the ultimate standard in client and candidate satisfaction. Visit www.sceaston.com for client critical information and exciting new careers!!!
Key words: GCP, 13485, CRA, CRC. RAPS, trials, evaluations, surgery, nurses, CRO, Monitor,

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