http://www.cytiva.com/agamed/ext/cojobs.asp RSS Web Feed for AGA Medical Corporation 11/21/2009 12:36:26 AM 11/21/2009 12:36:26 AM http://www.cytiva.com/agamed/ext/detail.asp?agamed1592 11/16/2009

The Senior Clinical Research Associate will design, implement, monitor and close-out clinical investigations under minimal supervision. He/she will also support professionalism and scientific expertise in the department.

Responsibilities:
• Knowledge of clinical research study processes and study design; ability to incorporate and adhere to Good Clinical Practices, regulatory standards and follow department Standard Operating Procedures.
• Assist in the trending of monitoring findings – taking the lead on resolution of compliance issues at assigned centers.
• Ability to conduct and perform monitoring activities.
• Performs the writing of AE/Death Summaries. Follow-up with any adverse event issues identified by the medical advisor.
• Strategically planning site and study financial matters (contracts and budgets).
• Leadership role in the creation of study training or other formal training at site and at the study team level.
• In-house case report form auditing and data verification.
• Management of assigned clinical study centers.
• Make presentation at study related functions (as required).
• Ability to critique and analyze data in reports and identification of potential trends.
• Assists in the development of regulatory submissions (annual reports, PMA).
• Problem solving capabilities – ability to overcome obstacles in the conduct of the clinical trial. Use of effective negotiation strategies. May independently implement solutions to issues.
• Capable of producing professional correspondence, presentations, reports and training materials. Creates study related materials, such as: subject brochures, subject recruitment materials, trial guide and physician referral presentations.
• Works under minimal supervision on specific study projects.
• Acquires professional, product and market expertise via independent reading, networking and training. Provide mentoring to team members as needed.
• Resource/train other clinical study team members. May serve as peer advisor for new team members.
• May provide assistance in the creation of annual operating plan.
• Travel approximately 10-20% (as project needs require).
• Participate in professional activities outside of normal business hours.
• Other duties as requested. Education:
• BA/BS in Medical Science, Nursing or related field. Requirements:
• 5+ years experience in clinical research, preferably medical device company.
• Computer proficiency required: Word, Excel, Access, PowerPoint, internet, email.
• Ability to constructively interact with a range of personalities and positions both inside and outside of the organization.
• Understanding of the therapy under investigation.
• Ability to organize, prioritizes, and manages tasks in a changing environment.
• Ability to work independently and take direction from others. ]]> 11/18/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1545 7/20/2009
  
  As an Software Quality Assurance Engineer, you will be responsible for the quality oversight and quality leadership for automated manufacturing and testing equipment and pure computer software validations as well as Calibration and Preventive maintenance program planning and execution.
  Responsibilities:
  • Work with Engineers and leadership in the IT/IS, Manufacturing, R&D and QA departments to control software changes.
  • Serve as a key team member in harmonizing and maintaining coordination of software validation program.
  • Create Quality System documentation and provide training on AGA’s software validation program.
  • Provide best-practice guidance for compliant change control in respect to 21 CFR 820, 11, ISO 13485 and SOX 404.
  • Create software validation deliverables or serve as the validation lead if required.
  • Peer review software validation deliverables as required.
  • Review and approve software validation deliverables, including final approval of systems for GxP use, when designated as the Quality reviewer by the Quality System Program Manager.
  • Lead the coordination of Calibration and Preventative Maintenance programs.
  Qualifications:
  • Bachelor's degree in related field.
  • 5 or more years of related professional experience required
  • Software validation experience
  • Training in and exposure to Calibration and Preventive Maintenance processes and tools
  • Experience in medical device industry preferred
  • Training in and exposure to validation processes, best practices and compliance considerations in the medical device industry.
  • Extensive Information Systems/Technology knowledge, including hardware, software, databases, operating systems. Programming knowledge is not required but is preferred.
  • In-depth understanding of ERP systems, data warehouse technology, automated manufacturing, environmental control, automated testing equipment, adverse events/medical reporting and clinical data systems.
  • Excellent organizational, interpersonal, and communication (verbal/written) skills.
  • Detailed-oriented.
  • Ability to constructively interact with a range of personalities and positions, both inside and outside the organization.
  • Ability to work creatively and productively with minimal supervision.
  • Ability to coordinate and ensure completion of program deliverables within predetermined timelines.
  ]]> 10/15/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1548 8/3/2009
  
  As a Senior Service Desk Specialist, you will respond to customer requests and work on Service Desk related projects. Customer requests may include, but are not limited to, installing software on a machine, setting up a new user, assisting someone with their blackberry or helping someone connect remotely.
  Responsibilities:
  • Provide Excellent Customer Service for desktop, application and overall IT support.
  • Strive to achieve first call resolution
  • Desktop Support including: installing new desktop/laptops, maintaining desktop images, desktop hardware lifecycle
  • Provide remote, Microsoft Office and Outlook support
  • Manage cellular phone requests
  • Active Directory Account Management for Change/Add/Remove of user IDs and AD Groups
  • Assist with the New Hire on-boarding process
  • Manage all Shared Copiers/Printers/Faxes
  • Manage small Service Desk Related Projects
  • Actively participate in Larger IT projects Qualifications:
  • Bachelors Degree in Computer Science or related field required.
  • 3+ years of related experience, with experience providing desktop support to Windows computer users, preferred.
  • Ability to interact professionally with all levels of the organization.
  • Ability to recognize and adapt to a changing environment.
  • Ability to work independently yet willing to take direction from others. Knowledge/Skills:
  • Advanced knowledge of Desktop and Laptop hardware
  • Advanced knowledge of Microsoft XP
  • Advanced knowledge of Symantec Ghost
  • Advanced knowledge for supporting remote users using VPN
  • Advanced knowledge of Microsoft office Products
  • Advanced knowledge of Printers and setting up print queues
  • Some knowledge of home wireless networks
  • Basic knowledge of Citrix Metaframe
  • Knowledge of how to configure an RSA token
  • Knowledge of how to run Queries in AD
  • Knowledge of how to create/delete users ID’s in AD
  • Knowledge of how to create and export mailboxes in Exchange
  • Knowledge of how to set up a phone on the Blackberry Enterprise Server (BES)
  • Experience with cellular phone support
  • Must be willing to challenge status quo and propose and implement leaner processes]]> 11/20/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1578 10/8/2009
    
    Summary: Compile, update and maintain Regulatory Affairs submissions in accordance with current country-specific regulations. Duties and Responsibilities:
  • Follow department Standard Operating Procedures.
  • Develop regulatory strategies for new devices as well as for manufacturing and design changes for existing devices for compliance to country-specific regulations.
  • Review device labeling and advertising materials for compliance to country-specific regulations.
  • Manage Product Release Authorizations and supporting documentation in required format for assigned countries.
  • Assemble and maintain regulatory submissions files.
  • Maintain knowledge of regulations and keep abreast of emerging regulatory changes for assigned countries.
  • Participate and/or lead process improvement initiatives to streamline regulatory submission preparation processes for assigned markets.
  • Participate in initiatives to identify regulatory requirements and develop submission processes for new AGA markets.
  • Other duties as requested. ]]> 10/8/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1429 10/9/2009
    
    As a Senior Design Assurance Engineer, you will have two key roles. You will be the key driver in assuring that our products meet the needs of the customer as you work as a core team member in partnership with a Product Development team. In addition, you will be the Lead for packaging design and development across multiple product development teams.
    Specific Design Assurance project activities include:
    • Work with the team to identify appropriate customer requirements for the product.
    • Work with the team to identify product specifications that correctly define the product.
    • Define the risk management approach.
    • Facilitate product risk analysis from a design and process perspective.
    • Provide insight and direction to appropriate inspection of materials.
    • Define with the team appropriate testing and develop the test plans.
    • Analyze testing results and confirm that our products meet the requirements set forth.
    • Provide clear concise documented evidence of the quality of our product to regulatory bodies.
    • Provide scope, deliverables planning, and timelines to the project for planning and subsequent management of product assurance deliverables to meet project timelines.
    Specific Packaging project activities include: Work with the product development team to identify packaging specifications.
    • Develop packaging concepts.
    • Work with external vendors to develop packaging concepts.
    • Define testing requirements and facilitate testing.
    • Create plans and reports.
    Additional activities include:
    • Assist in the development of QA/QC policies and procedure to ensure department efficiency and compliance to appropriate regulations.
    • Conduct training as needed on design assurance methodology, concepts and tools.
    • Support the quality objectives of other engineering disciplines within product development as needed.
    Qaualifications:
    • BS degree in Engineering or related field.
    • Preferred work experience of 5-7 years in Product(Design) Assurance Engineering.
    • Preferred experience of at least 2 years in conducting product risk analysis.
    • Knowledge and application of QSR, ISO and other applicable international regulations.
    • Knowledge and application of mechanical measurement systems, measurement techniques and process capability studies.
    • Ability to read mechanical drawings, understand geometric dimensioning & tolerancing and design appropriate inspection methods to ensure design intent is maintained.
    • Ability to interact effectively with a cross-function team.
    • Ability to facilitate meetings.
    • Computer efficiency in Microsoft programs relevant to job responsibilities.
    • Ability to constructively interact with a range of personalities at many levels of the organization.
    • Experience in medical device industry preferred. 10/9/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1585 10/16/2009
      
      With support from cross-functional team members, the R&D Project Manager is responsible for the organization, planning, and on-time execution of product development projects.
      Responsibilities:
      • Manages large cross-functional product development teams.
      • May provide input to other functional leaders on team and team member performance.
      • Manages the technical challenges of technology application and new product development.
      • Identifies, communicates, and manages moderate to high levels of technical risk.
      • Develops and implements project plan; builds team ownership and commitment to project plan.
      • Communicates within the project team and across other business functions.
      • Leads and influences resolution of cross-functional issues.
      • Applies project management best practices in the development, initiation, planning, execution, control, and closing of projects.
      • Provides clear direction on product development requirements to meet expectations of external customers and business stakeholders.
      • Interacts with research and development, marketing, manufacturing, clinical, and regulatory departments and with external stakeholders.
      • Responsible for project performance, risk management, and issue resolution.
      • Assesses project issues and develops resolutions to meet productivity, quality, and customer-satisfaction goals and objectives.
      • Develops mechanisms for monitoring project progress and for intervention and problem solving with team members. Education:
      • Bachelors Degree (Engineering/Technical field desired) required. Advanced degree preferred. Experience:
      • 8-10 years related work experience (5+ within project management) including product development from concept through trials and production ramp-up.
      • Prefer Product Development Process (PDP) experience of at least one year.
      • Experience with nitinol, braiding, and/or plastic/polymer process preferred.
      • Project Management Professional (PMP) certification preferred.
      • Demonstrated leadership ability, as seen in initiating, leading, and driving departmental and organizational change.
      • Ability to communicate in a matrixed organization, with all levels of management and employees.
      • Business experience demonstrated through business knowledge, leadership skills and process development capabilities.
      • Computer proficiency required: MS Project, Word, Excel, Access, PowerPoint, Outlook, Internet, etc. ]]> 10/16/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1580 10/9/2009
        
        As a Product Quality Analyst you will support to two key areas of daily AGA manufacturing; (1) you will facilitate Engineering Change Order processes within documentation control / configuration management system, and (2) you will lead Product Release to finished goods.
        Daily Documentation Control and Configuration Management (approximately 50% of time):
        • Provides necessary support to ensure proper creation, coordination, filing management, storage, and retrieval of all controlled engineering and quality system documentation.
        • Creates and maintains configuration for the Item Master List and Bill of Material (BOM); this includes consulting with Engineering Change Order originators to determine appropriate Item Master/BOM information based on engineering drawings and other product data.
        • Maintains established product configuration identification system including part numbering, naming, nomenclature, etc.
        • Trains appropriate AGA personnel on aspects of the documentation control system as required.
        • Maintains currency of related databases.
        • Assures that documentation conforms to appropriate AGA and Regulatory requirements. Daily Product Release to Finished Goods (approximately 50% of time):
        • Leads the day-to-day processes associated with the release of products to Finished Goods.
        • Compiles documentation in preparation for product release, ensuring information is present, accurate, and meets all requirements. When issues are identified, the Analyst leads resolution efforts.
        • Assures microbiology laboratory receives documentation and product required to complete LAL and bioburden testing in a timely manner. Also reviews laboratory test reports for acceptability.
        • Responsible for providing daily product release updates daily in Quality Log and upon demand
        • Ensures that priorities and actions are transparent to cross-functional team members and that goals are being met; this will often involve reprioritizing efforts and balancing documentation control/configuration management demands with the day-to-day demands of releasing product.
        • Serves as primary contact for sterilization documentation or laboratory documentation issues.
        • Maintains a broad-based knowledge of Regulations, AGA SOPs and practices, and evolving regulatory trends; assesses them for impact on AGA and implements change accordingly.
        • Writes, reviews, and approves procedures; updates product release procedures as necessary.
        • Performs quality trending on a monthly basis. Recommends and implements improvements for better system utilization to improve efficiencies and minimize errors.
        • Maintains a visual workplace, utilizing Lean 5S techniques. The successful candidate must possess the following educational and skill requirements:
        • Bachelor’s degree in related field.
        • Minimum 5 years experience in Documentation Control, Product Release, or combination thereof.
        • Previous experience in the Medical Device or Pharmaceutical industry.
        • Superior communication skills and proven ability to produce clear, accurate documentation.
        • Ability to interpret engineering drawings and harmonize information with related technical documentation.
        • Prior experience with Agile and JD Edwards preferred. ]]> 10/9/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1576 9/30/2009
          
          As a Principal R&D Engineer, you will provide technical engineering to lead product development and transfer of innovative, minimally invasive medical products from research through manufacturing including the design, development, testing and documentation in accordance with design control procedures. The primary role is within the product development process, representing the R&D function. In this role you will lead development efforts to generate the necessary documentation and data to convey design intent and support submission of these devices to regulatory agencies for approval.
          • Design and develop new interventional medical devices following design control procedures
          • Construct and evaluate prototype medical devices
          • Generate the necessary documentation to convey design intent – including drawings, material specifications, protocols and reports
          • Maintain a detailed laboratory notebook
          • Translate design inputs into engineering specifications
          • Identify and establish relationships with key suppliers for research and development and production components
          • Create detailed design risk analysis reports
          • Perform design verification and validation testing
          • Prepare time lines, cost analyses and resource needs
          • Lead project teams
          • Perform all job functions in accordance with applicable AGA, FDA, and ISO standards
          Qualifications:
          • BS in Engineering or related area
          • Eight plus years of medical device R&D experience
          • Good written and verbal communication, record keeping and technical documentation
          • Demonstrated problem solving and decision making skills
          • Demonstrated creativity and "hands on" prototyping skills
          • Working knowledge of ISO, GMP, and FDA experience is a plus
          • Computer proficiency with Microsoft applications
          • FEA and Minitab knowledge desired
          • Ability to work independently and take initiative
          • Experience with cross-functional team based Product development
          • Experience with machine shop, extrusion, braiding, or laser weld desired
          • Design experience with nitinol a plus
          • Supervisory experience a plus
          ]]> 10/5/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1586 10/19/2009
          
          As a International Product Marketing Manager Structural Heart, you will support the International sales and marketing strategies by working with and leading internal staff and sales representatives to develop marketing strategies and programs that drive growth of AGA’s Structural Heart Product Lines.
          Responsibilities:
          • Devise business plans and strategies for growth in Structural Heart products outside of US
          • Develop and implement tactical marketing programs and deliverables to capitalize on opportunities with existing products and new products
          • Revenue Driver: Ensure that the Sales organizations and distributors are fully supported and prepared with the knowledge and tools necessary to capitalize on revenue growth opportunities.
          • Implement product promotion programs: (1)Assist in creating/maintaining/upgrading all collateral material including brochures, spec sheets, slides, case studies, launch kits, and reference manuals. (2) Ensure that proper internal review is complete. (3) Monitor competitive activity and product positioning.
          • Assist in opinion leader/proctor development and in managing global physician relations.
          • Become expert on AGA Structural products and their application.
          • Product training: Lead product training for internal sales representatives
          • Logistics support: Work with Operations and Clinical departments to ensure that product forecasting is complete to ensure adequate inventories for clinical trials and product introductions.
          • Forecast: Drive annual and quarterly forecast plans on product lines in collaboration Qualifications:
          • BS/BA in business or health sciences. MBA preferred.
          • Three to Five years experience in medical device marketing. Sales experience desirable and peripheral vascular experience or interventional cardiology experience preferred.
          • Ability to work with a cross-functional team and seek consensus/approval where needed.
          • Ability to work independently and take direction from others.
          • Able to help determine product positioning and create promotional/launch programs for our global customers.
          • Strong interpersonal communications skills for both internal and external customers.
          • Ability to make large, interdisciplinary group presentations.
          • Financial analysis skills to enable support of corporate strategic decisions. Budgeting skills.
          • Basic computer skills, Word, Excel etc.
          • Good basic understanding of anatomy, cardiology in particular.
          • Leadership skills in persuasion, building consensus, and a company-wide view of initiatives.
          • Ability to travel 30-40%. ]]> 11/5/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1591 11/13/2009
            
            As a Field Sales Representative - Great Lakes Territory, you will be responsible for sales to the pediatric and adult interventional cardiologists, market development, and key account responsibility for AMPLATZER structural heart devices and accessories.
            • Meet sales and expense quotas.
            • Grow the current customer sales base and develop new accounts within the assigned sales territory.
            • Develop K.O.L. (Key Opinion Leaders) and utilize for preceptorship, training and physician to physician teaching/selling.
            • Responsible for building relationships with multiple customers within an account and keeping them informed of new products, and new procedures.
            • Develop and maintain an in-depth knowledge of your accounts through profiling, to include competitor activity, market share per product, key contact and decision makers and accurate business forecasts.
            • Provide supply/inventory and pricing trend information to sales management.
            • Required to travel 75 – 80% (evenings and weekends as required).
            • Provide technical updates to hospital staff.
            • Attend medical conferences.
            • Provide weekly, monthly, and quarterly reports to sales manager.
            Qualifications:
            • Bachelor’s Degree in related field or the equivalent combination of education and experience in the interventional radiology and /or vascular surgery lab.
            • A Minimum of 3 years medical sales experience with wire and catheter-based products preferred. Interventional cardiology sales experience a definite plus!
            • Excellent customer service and presentation skills.
            • Working knowledge of Microsoft products – Word, Excel, PowerPoint.
            • Working knowledge of Customer Relationship Management software – Pivotal preferred.
            • Ability to work well in a team environment.- Must be a self-starter.
            • Work hour flexibility required - some evenings and weekends.
            • Current and Valid Driver’s license is required.
            • Willing to travel 75 – 80%.
            ]]> 11/16/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1553 8/10/2009
            
            As a Field Clinical Specialist, you will be responsible for coordination and support of physician and catheterization lab training and on-going clinical education related to the family of AMPLATZER Occlusion devices.
            Responsibilities:
            • Coordination and support of physician and cath lab proctoring sessions.
            • Case support/clinical support related to device use within approved indications.
            • Provide clinical and technical updates to hospital staff.
            • Clinical field sales training and support of the sales team.
            • CRM database customer account management and update.
            • Attend and support medical conferences.
            • Trunk stock inventory management.
            • Develop K.O.L. (Key Opinion Leaders) and utilize for preceptorship, training and physician to physician teaching/selling.
            • Responsible for building relationships with multiple customers within an account and keeping them informed of new products, and new procedures.
            • Develop and maintain an in-depth knowledge of your accounts through profiling, to include competitor activity, market share per product, key contact and decision makers and accurate business forecasts.
            • Provide supply/inventory and pricing trend information to sales management.
            • Required to travel 75 – 80% (evenings and weekends as required).
            • Provide weekly, monthly, and quarterly reports to sales manager.
            Qualifications:
            • Bachelor’s Degree in Life Science or related area.
            • Three (3) years experience as a CVT or RT working in the cardiac catheterization laboratory and one to three years industry experience as a clinical product specialist.
            • Excellent customer service and presentation skills.
            • Microsoft – Word, Excel, PowerPoint.
            • Pivotal – Customer Relationship Management software.
            • Must be a self-starter.
            • Must be adaptable, flexible, and capable to present strong and effective clinical and technical presentations related to structural and congenital heart defects.
            • Ability to understand interventional cardiology procedures and terminology.
            • Strong communication and interpersonal skills.
            • Ability to handle difficult situations and/or conversations.
            • Current and Valid Driver’s license is required.
            • Willing to travel 75 – 80%.
            • Work hour flexibility required - some evenings and weekends.
            ]]> 8/19/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1582 10/8/2009
            
            As a Field Clinical Specialist, you will be responsible for coordination and support of physician and catheterization lab training and on-going clinical education related to the family of AMPLATZER Occlusion devices.
            Responsibilities:
            • Coordination and support of physician and cath lab proctoring sessions.
            • Case support/clinical support related to device use within approved indications.
            • Provide clinical and technical updates to hospital staff.
            • Clinical field sales training and support of the sales team.
            • CRM database customer account management and update.
            • Attend and support medical conferences.
            • Trunk stock inventory management.
            • Develop K.O.L. (Key Opinion Leaders) and utilize for preceptorship, training and physician to physician teaching/selling.
            • Responsible for building relationships with multiple customers within an account and keeping them informed of new products, and new procedures.
            • Develop and maintain an in-depth knowledge of your accounts through profiling, to include competitor activity, market share per product, key contact and decision makers and accurate business forecasts.
            • Provide supply/inventory and pricing trend information to sales management.
            • Required to travel 75 – 80% (evenings and weekends as required).
            • Provide weekly, monthly, and quarterly reports to sales manager.
            Qualifications:
            • Bachelor’s Degree in Life Science or related area.
            • Three (3) years experience as a CVT or RT working in the cardiac catheterization laboratory and one to three years industry experience as a clinical product specialist.
            • Excellent customer service and presentation skills.
            • Microsoft – Word, Excel, PowerPoint.
            • Pivotal – Customer Relationship Management software.
            • Must be a self-starter.
            • Must be adaptable, flexible, and capable to present strong and effective clinical and technical presentations related to structural and congenital heart defects.
            • Ability to understand interventional cardiology procedures and terminology.
            • Strong communication and interpersonal skills.
            • Ability to handle difficult situations and/or conversations.
            • Current and Valid Driver’s license is required.
            • Willing to travel 75 – 80%.
            • Work hour flexibility required - some evenings and weekends.
            ]]> 10/8/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1589 11/4/2009
            
            As a Data Warehouse / ETL Developer, you would work closely with the Information Systems team in maintaining and enhancing the infrastructure for reporting / business analytics. This person will be primarily responsible for:
            • ETL development & production support
            • Creation of Data Warehouse system validation plans
            Qualifications:
            • Bachelors degree in Information Systems or a related field
            • Familiarity with standard relational and dimensional database concepts and best practices
            • Working knowledge of Data Warehouse concepts: OLAP, ROLAP, dimensions, facts
            • Working knowledge of Microsoft SQL and Oracle database systems
            • Understanding of common business systems (ERP, CRM, PLM, Clinical)
            • Familiarity with working in a regulated environment
            • Ability to communicate with business users and technology staff in order to implement business solutions
            • 3-5 years of Business Intelligence / Data Warehouse experience including experience with ETL development OR 2+ years experience coding ETL with Outlooksoft (SAP BPC v5.x) SSIS plug-ins
            • Working knowledge of Microsoft SQL Server Integration Services preferred
            • Other programming experience preferred (Visual Basic.net, Java, etc.)
            • Certified Business Intelligence Professional (CBIP certification) preferred
            Position Responsibilities will be broken down as follows:
            • ETL: 50%
            • Production Support: 30%
            • Validation / Testing: 20%
            ]]> 11/5/2009 http://www.cytiva.com/agamed/ext/detail.asp?agamed1587 10/23/2009
            
            As the Clinical Programs Manager, you will manage the successful completion of all Pediatric and Post Approval clinical programs for AGA Medical as well as be responsible for developing program budgets and hitting both enrollment and spending targets. You will staff, manage and ensure competency of Clinical Research Associates including their knowledge and compliance with SOPs. The Clinical Programs Manager will build and maintain relationships with clinical trial sites and principal investigators plus develop and maintain tools for tracking progress against department goals and objectives. You will participate in the design of new trials and the selection of trial sites ad well as manage the timely development of PMA and other regulatory submissions.
            Responsibilities:
            • Manage the successful and timely execution of all device clinical trials for AGA Medical.
            • Select, train and manage all Clinical Research Associates including their training and compliance with all SOPs and associated regulations.
            • Lead the training, initiation and management of clinical trial sites.
            • Establish and manage trial budgets including enrollment targets. Report regularly on performance against plan including steps to overcome any shortfalls in enrollment or overages in spending.
            • Participate in the design and development of new trials.
            • Develop the clinical component of regulatory submissions including 510(k)s and PMAs including validation of the associated data analysis.
            • Develop and maintain individual training programs for all staff.
            • Assist in the drafting and development of publications based on the results of the clinical trials.
            • Ensure all staff maintain relevant professional certifications and remain current with the latest development in interventional cardiology and structural heart defects.
            • Develop and maintain strong relationships with principal investigators at clinical trial sites.
            • Ensure that AGA Medical is using the most current tools in the management of clinical trials. Qualifications:
            • BA/BS in life sciences or nursing.
            • Advanced degree in life sciences or nursing a strong plus.
            • 5-10 years experience in clinical research management, preferably medical device company developing products for use in interventional cardiology.
            • Demonstrated and successful management experience of a clinical team of a minimum of 5-10 professionals.
            • Demonstrated knowledge of and experience with GCP and all US regulations.
            • Knowledge and experience with European and Japan device clinical trials a strong plus.
            • Hands on experience in the preparation of PMAs and 510(k)s or equivalent non-device regulatory submissions.
            • Comfortable in both the clinical and business setting. Comfortable presenting to senior management.
            • Ability to work independently and take direction from others.
            • Strong work ethic and willing to travel up to 30%.
            • Excellent communication, problem-solving and organizational skills.
            • Computer proficiency including Microsoft Office applications.]]> 11/17/2009