Career Opportunities at DFINE

At DFINE, employees are our greatest assets. Our success depends upon recruiting and retaining talented, enthusiastic and dedicated people. We do this by providing a dynamic and challenging work environment in which our employees can thrive.

We are a unique team that welcomes diversity of background and experience. DFINE is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.
 
 

Controller
Clinical Data Coordinator
IT Business Analyst 
R&D Engineer 
Senior Manufacturing Engineer
Territory Sales Manager
Quality Engineer
Clinical Support
Director of Clinical Affairs


Controller 



Position Summary:

Under the general direction of CEO, oversees all operations in connection with financial matters, including accounts receivable and payable, payroll, and auditing; trains and supervises department staff; develops and initiates systems, policies, and procedures for transacting financial matters; ensures that the financial system is accurate, efficient, and in accordance with professional accounting practices and governments regulations.
 
Authorities: 

Has authority to initiate action to prevent the occurrence of any non-conformities relating to product, process and quality system and to control further processing, delivery or installation of non-confirming product until the deficiency or unsatisfactory condition has been corrected.
 
Duties and Responsibilities: 
  • Demonstrate a commitment to the quality system, visibly and actively, on a continuing basis.
  • Develops and implements the Accounting Department’s goals, projects, policies, procedures, methods, and controls.  
  • Directs the general accounting activities including maintenance of general ledgers, analysis of computer printouts, and review of payroll records.  
  • Prepares monthly and close-out reports as required by state and federal regulations; profit-loss statements, annual corporate tax returns and special financial reports, studies, and analyses.  
  • Develops and maintains internal audit control system.  
  • Develops and administers the cash management program.
  • Provides data, reports, and other information to assist in the preparation of the annual budget.
  • Forecasts revenues, expenditure, and year-end balances.
  • Plans, designs, implements, and modifies the data processing system.
  • Prepares and revises the fiscal operations procedure manual.
  • Coordinates with other departments concerning short- and long-range fiscal needs and plans.
  • Responds to requests for information.
  • Supervises daily accounting operations, especially the verifying and signing of payroll and cash disbursement.
  • Selects, trains, supervises, and evaluates accounting staff.
  • Be aware of the Quality Policy and Quality Objectives and provide support to meet them.
  • Be aware of the Quality Manual and follow as it applies to the function.
  • Other duties as assigned.
Position Requirements: 
  • Principles, practices, and methods of modern accounting and auditing.
  • Principles and practices of financial administration including budgeting and reporting.
  • Modern office practices, procedures, methods and equipment.
  • Modern principles and practices in operations procedures and data processing.
  • Application of data processing in the maintenance of accounting records and financial administration.
  • Budget preparation, program analyses, and revenue forecasting.
  • Principles and practices of organization, administration, budget, and management.
  • Reports accounting practices required by state and federal regulations.
  • Planning, coordinating, and directing a complex financial operation.
  • Developing, revising and installing accounting systems and procedures.
  • Interpreting, and applying appropriate laws and regulations.
  • Preparing varied financial statements, reports, and analyses.
  • Communicating clearly and concisely orally and in writing.
Education Requirements:
  • Bachelor’s Degree in Accounting or Business Administration with an accounting concentration from an accredited college or university.
 
Experience Requirements:
  • Four (4) year’s progressively responsible experience in accounting, of which two (2) years were in a supervisory capacity.
  • Two (2) to four (4) plus years experience in a manufacturing company.  Ideal qualifications would include experience with a company making and selling medical device, biotechnology or pharmaceutical product within the U.S.
 
Special Requirements:
  • Accounting experience with private and publicly traded company.  International experiences a plus.
  • Previous public, private equity financing and investor relations experience.
 
Preferred Requirements:
  • Certified Public Accountant (CPA) Certificate.
 
Note:  This job description is an outline of the major recurring responsibilities of the job/position.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.  Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Click here to apply for this position.
 
Clinical Data Coordinator


Position Summary:


Perform all aspects of data management tasks from participation in database development and assisting in clinical trial preparation through close-out of study.  Responsibilities include both administrative and clinical support functions. Responsible for data collected from all clinical trials or commercial series.  Support development of database and Case Report Forms, data management plans as well as review and query the data to insure clinical data collected is complete, accurate and of highest quality possible. Support for adverse event and medication coding, site and clinical associate training, participate in quality control audits, database lock(s) and will assist in final clinical study report writing and review.
 
Duties and Responsibilities:    
  • Participate in protocol review, focusing on data management issues and cross-study data collection consistency. 
  • Participate in the design, documentation, testing and implementation of clinical data collection using electronic data capture (EDC) systems. Includes design of eCRFs, edit check specifications, eCRF Completion Guidelines and Data Management Plans (DMPs).
  • For EDC, participate to ensure that user acceptance testing is completed prior to implementation and deployment to clinical trial sites.  Ensure that the requirements for data transfers and integration with other systems are defined.
  • For EDC, participate in the review and resolution of data discrepancies per procedures and guidelines.
  • For paper CRFs, post CRA data reviews, oversee DCF’s (Data Clarification Form) for completeness, consistency and clarity.  Managing and tracking CRF flow, including scanning as required. Enter and update data as needed.
  • Collaborate with outside vendors/institutions to aid in data analysis programming and data clean up.
  • Participate in the development of and maintenance of study database metrics.
  • Participate in the coding of medications, adverse events, and/or medical history using current WHO-Drug/MedDRA dictionaries.
  • Provide project/study support for all activities required to initiate, monitor, and close clinical studies and marketing evaluations for U.S. and European Clinical Trials consistent with applicable regulations, guidelines and policies.
  • Assist in preparation of study material for investigator, study coordinator and monitor meetings.
  • Monitor compliance with department procedures pertaining to data collection, entry, monitoring, clarification, and analyses
  • Prepare data for publication or presentation
  • Maintain databases listed below and associated clinical infrastructure processes
  • Clinical Cost Database - relates to Clinical Accrual reports to Finance
  • Investigator File Database
  • Materials Database - relates to managing device inventory at sites
  • Manage the process of recording completed clinical work for payment. Acts as liaison with Finance dept and financial auditors.
  • Keeps abreast of the basic requirements on clinical/regulatory issues in the area of clinical data management.
  • Assist with Investigator and site staff training.
  • Supports  administrative activities such as business travel, expense reports, Board of Director presentations, Monthly Clinical internal communications among senior staff, report writing, and document preparation.
  • Supports  assigned regulatory related projects involving clinical or scientific and medical affairs regarding product registrations, approvals, and post-marketing compliance. This may include the review, evaluation, and compilation of files and reports for submissions.
  • Participate in generation and reviews of technical and clinical documentation and reports.
  • Responsible for timely completion of clinical submissions in collaboration with Regulatory and Quality Assurance.
  • Assist clinical team in filing study documents, communicating with sites.
  • Review and verify adequacy of center activation documentation, site initiation and compliance documentation.
  • Assist in coordinating activities performed by independent CRAs, Contract Research Organizations and Core Labs.
  • Assist in preparing study documents such as study manuals, worksheets etc.
  • Other duties as assigned.

Education Requirements:
  • BA or BS degree or scientific field preferred or equivalent experience.
  • Experience Requirements:
  • Minimum of 3 years of clinical data management experience with demonstrated excellent data management skills on various types of clinical trials (Pharma and/or Device).
  • Experience using Clinical Data Management and/or Electronic Data Capture products (e.g. Veracity, Oracle Clinical, Phase Forward, Medidata, eClinical, etc.).
  • Excellent organizational skills with attention to detail.
  • Excellent written and oral communication skills.
  • Computer literacy, proficiency in MS Office, Excel, Power Point, etc.
  • Strong interpersonal skills.
  • Some knowledge in regulatory requirements, such as FDA, ICH, GCP etc. guidance.
  • Ability to complete deliverables on time and adjust priorities in a fast paced environment
  • Ability to work independently as well as collaboratively in a team environment
  • Knowledge of CTMS systems is a plus
  • Statistical knowledge or basic level SAS knowledge a plus
  • Some experience in regulatory submission of medical devices (510K, class III devices, PMA) or drugs (NDA, CTD) is helpful.
  • MedDRA/WHO-Drug coding experience is preferred.
Note:  This job description is an outline of the major recurring responsibilities of the job/position.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.  Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Click here to apply for this position.

IT Business Analyst 


Position Summary:

The Business Analyst will help design, plan, and manage global enterprise applications to support the business.  As well as implementation and maintenance, this position will encourage and train end users in the effective use of enterprise business applications.
 
Authorities: 

Has authority to initiate action to plan, design, develop, plan and manage global enterprise applications to support the business.  
 
Duties and Responsibilities: 
  • Coordinate activities of IT ERP application, with the responsibility for completing development, enhancements, and reporting activities on time and quality focused
  • Provide support for application maintenance, including databases to support an objective of Operational Excellence in IT
  • Gather, define, and document business requirements, formulate functional and technical specifications for the corporate ERP system
  • Actively promote effective use of enterprise systems across the organization
  • Provide reporting, training, and documentation for enterprise applications including best practices
  • Ensure compliance to Sarbanes-Oxley, FDA and other regulatory agency requirements
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, performance management programs, and FDA regulations
  • Administer, maintain and implement policies and procedures for ensuring the security, and integrity of the company’s database
  • Implement data models and database performance issues, database capacity issues, replication, and other distributed data issues
  • Install, configure and maintain applications software
  • Analyze and develop labels and reports using Windows NT, UNIX Shell Script, Company ERP application and Progress 4GL functions
  • Other duties as assigned
Position Requirements: 
  • Principles, practices, and methods of modern ERP application reporting.
  • Principles and practices of defining end-user requirements for development and reporting.
  • Modern office practices, procedures, methods and equipment.
  • Modern principles and practices in operations procedures and data processing.
  • Application of data processing in the maintenance of company records and administration.
  • Ability to develop policies and procedures for ensuring the security and integrity of the company’s data.
  • Support reporting required by state and federal regulations.
  • Developing, revising and installing ERP systems and associated business applications.
  • Interpreting and applying appropriate laws and regulations.
  • Communicating clearly and concisely orally and in writing.
Education Requirements:
  • B.S. / M.S. in Computer Science/Engineering or equivalent experience.
 
Experience Requirements:
  • Minimum of 5-7 years of experience working with Business Applications 
  • Experience with global enterprise ERP (prefer QAD) and CRM (tier 1 or tier 2) system
  • Experience with Progress RDMS, and 4GL administration
  • Software development experience including SDLC 
  • Experience working in medical device or other parts of the life sciences industry is preferred
  • Scripting skills for automation purposes are helpful
     
Special Requirements:
  • Functional knowledge of Front Office (Marketing, Sales, Service) and Back Office (Finance, Manufacturing, Quality) automation and best practices
  • Ability and desire to learn quickly and share knowledge 
  • Excellent communication, interpersonal, and customer service skills
Note:  This job description is an outline of the major recurring responsibilities of the job/position.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.  Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Click here to apply for this position.
 



R&D Engineer 


Position Summary:
Responsible for designing, documenting, and verifying the product 
 
Authorities: 
Has the authority to identify and record problems relating to product and component design and to recommend or provide solutions Direct Contract Manufacturers, engineers and technicians. Interface with vendors, order parts, materials. Support Manufacturing and R&D goals.
 
Duties and Responsibilities:
  • Design and develop product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO and MDD requirements.
  • Responsible for ensuring proper documentation consistent with company’s quality system.
  • Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives.
  • Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
  • Develop solutions to design problems through the application of engineering principals, analysis, and empirical methods 
  • Develop solutions to design problems through the application of engineering principals, analysis, and empirical methods.
  • Model complex components and assemblies in CAD and create detailed drawings.
  • Build and test prototype designs for proof of concept.
  • Develop protocols and perform product verification and validation testing.
  • Perform process-related design tasks to support pilot manufacturing.
  • Support production of final product by troubleshooting manufacturing processes.
  • Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
  • Enhance the intellectual property position of the company via invention disclosures and patent applications.
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
  • Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
  • Responsible for component documentation
  • Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
  • Other duties as assigned.
     
Position Requirements:
  • Must posses good interpersonal and communication skills, and work in a collaborative style.
  • Good technical skills and proven engineering problem solving ability.
Education Requirements:
  • Bachelor’s Degree in Mechanical or Biomedical engineering or equivalent experience.
Experience Requirements:
  • 2 plus years experience in engineering preferably in the medical device and/or pharmaceutical industry. 
Special Requirements:
  • Experience using CAD tools (SolidWorks preferred).
  • Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
Note:  This job description is an outline of the major recurring responsibilities of the job/position.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.  Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Click here to apply for this position.
 



Senior Manufacturing Engineer 


Position Summary:
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.
 
Duties and Responsibilities:
  • Design and develop manufacturing processes for new products and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost
  • Responsible for ensuring proper documentation consistent with company’s quality system.
  • Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives
  • Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP
  • Responsible for identifying issues in manufacturing and resolving them per the quality system requirements
  • Proactively work with QA/RA to ensure any and all issues are addressed per the requirements of the quality system and ISO 13485, MDD and QSRs
  • Ensure changes to processes have thorough justification and where applicable, validated to meet the regulations and the Company’s quality system
  • Ensure new tools/jigs, fixture, equipment or modifications to existing such items are only introduced in manufacturing upon completion of IQ, OQ, PQ applicable to the tools/jigs, fixture, equipment
  • Maintain accurate and timely preventive maintenance of equipment and tooling. 
  • Ensure the manufacturing processes meet the approved MPIs, STMs, QPIs, etc.
  • Ensure all equipment, tool, fixtures used for testing are calibrated, as appropriate, and/or inspected/verified to be traceable within the Quality System (per SOP 0005) and conforming to their specifications
  • Ensure the test protocols and reports are thorough, complete, provide all required details to reproduce the study at a later date.  Ensure the data sheets for the studies are well designed to capture all required data
  • Perform testing per GLP guidelines with emphasis to test sample identification, traceability, sterilization processing
  • Develop protocols and perform product verification and validation testing.
  • Perform process-related design tasks to support pilot manufacturing
  • Support production of final product by troubleshooting manufacturing processes
  • Identify suppliers and maintain relationships to ensure the delivery of superior components and services
  • Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
  • Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions
  • Support company goals and quality policy, quality objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Position Requirements:
  • Must posses good interpersonal and communication skills, and work in a collaborative style
  • Good technical skills and proven engineering problem solving ability
  • Must have the ability to mentor junior Engineers and Technicians
  • Other duties as assigned
Education Requirements:
  • Bachelor’s Degree (Master’s preferred) in Electrical, Manufacturing, Mechanical or Biomedical engineering or equivalent experience
Experience Requirements:
  • Minimum of eight years experience in engineering preferably in the medical device and/or pharmaceutical industry preferred
Special Requirements:
  • Experience using CAD tools (SolidWorks preferred)
  • Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
Note:  This job description is an outline of the major recurring responsibilities of the job/position.  It is not intended to be all-inclusive of the work to be performed.  Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent.  Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Click here to apply for this position.


 

Territory Sales Manager

Position Summary

Sales and territory management responsibility within a designated geography.

Authorities

  • Has authority to make decisions and implement programs/action items within the specific province of sales in a designated geographic area.

Duties and Responsibilities

  • Execution of sales plan
  • Management of accounts within sales territory
  • Presenting DFINE technology to physicians and facilities
  • In-service of DFINE products to physicians and facilities
  • Must be capable of providing verbal technical assistance as it pertains to the use of our products/systems in compliance with approved Information for Use documentation
  • Maintain up to date Vendor Credential requirements for all accounts within your respective geography
  • Complete and submit Case Reporting Forms for all cases conducted within your respective geography
  • Effective management of DFINE consignment inventory including but not limited to monthly count, expiry management, product exchange/return
  • Effective management of territory expenses against budget
  • Conduct your business and interactions with customers/accounts in strict compliance of AdvaMed guidelines
  • Report all Product Complaints (any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution) and all relevant information on the complaint to DFINE headquarters in San Jose in a timely manner
  • For Product Complaints, ensure all related and/or affected devices are returned for investigation to DFINE headquarters in San Jose
  • For all incidents related to Patient Injury, provide all relevant information to DFINE headquarters to meet the USFDA's Medical Device Reporting guidelines
  • Be aware of the Company's Quality Manual and Quality Policy
  • Other duties as assigned

Position Requirements

  • Excellent written and oral communication skills
  • Extensive knowledge of OR medical device market
  • Excellent negotiation and closing skills
  • Demonstrated ability to plan and execute
  • Documented history of achievement
  • Proficient computer skills specifically related to Microsoft Office
  • Must demonstrate a confident, hard charging, winner's presence
Education Requirements
  • 4-year Bachelors degree or equivalent experience

Experience Requirements

  • 5-7 years O.R. sales experience with focus on but not limited to: spine, orthopedics, neurosurgery, interventional radiology
  • Background must include successful record of achievement in both capital equipment and disposable sales
  • Top 10% record of achievement in prior positions
  • Superior knowledge of territory and current customer relationships

Click here to apply for this position.
 
 


Quality Engineer


Position Summary:

Use disciplined approach with technical, statistics and knowledge of national and international standards and regulatory requirements to ensure that products are developed and manufactured in compliance with the Company’s quality system and regulatory requirements in support of Company’s strategic plan and Department/Individual goals.

Authorities:

Has the authority to identify deficiencies in quality system, and device performance and recommend and implement corrective and preventive actions which includes design and process verifications and validations.

Duties and Responsibilities:
  • Responsible for developing test methods and documenting protocols/reports to verify and validate device design, process, sterilization, biocompatibility, etc.
  • Responsible for investigating CAPAs, Product Complaints, Non-Conforming Material reports and identifying and implementing effective corrective and preventive actions.
  • Performs trend analysis and establish corrective/preventive actions as required.
  • Responsible for set-up and validation of test methods, procedures and sampling plans for inspection and testing of finished products.
  • Responsible for ensuring system hazard analysis, design and process FMEAs are conducted per ISO 14971.
  • Responsible for initiation and approval of document change orders (DCOs) with proper documentation of change, reasons and justifications.
  • Responsible for monitoring supplier quality.
  • As necessary, perform supplier audits to ensure continued compliance and acceptability.
  • Perform statistical analysis of data to arrive at robust conclusions.
  • Perform robust root cause and corrective action analysis.
  • Responsible for control, disposition and solid root cause/corrective action analysis of non-conformance reports.
  • Monitor effectiveness of sampling plans (size and frequency), inspection and tests performed and test methods.
  • Perform internal audits per the audit plan and implement/assist in implementing corrective and preventive actions.
  • Recommends improvements in quality system to ensure that the quality system is efficient and effective controls are in place to minimize risk.
  • Follow and enforce compliance to the Company’s quality system and regulatory body requirements per ISO 13485/FDA’s QSRs and applicable national and international standards.
  • Responsible for being aware of Company’s quality policy and quality objectives and provide support to achieve them.
  • Complete projects in a timely manner and consistent with corporate objectives.
  • Identify needs and document SOPs, test methods, protocols, reports, DCOs, etc.
  • Interface with suppliers, contract manufacturers, contract developers.
  • Ensure proper documentation of Design History Files per the company’s procedures.
  • Prepare deliverables for Management Reviews.
  • Other duties as assigned.
Position Requirements:
  • Proficient in use of MSWord, MSExcel, is required.
  • Ability to work well under pressure and handle multiple projects and meet deadlines.
  • Ability to read and understand regulations, standards and procedures.
  • Ability to perform statistical analysis of data is required.
  • Good leadership, analytical and interpersonal skills.
Education Requirements:
  • 5+ years quality engineering/assurance/control experience with sterile medical devices
  • Thorough knowledge and understanding of FDA’s QSRs, ISO 13485:2003 and MDD 93/42/EEC and other national/international standards.
  • High level of attention to details skills.
  • High level of organization skills.
  • Strong statistical skills are required.
  • Hands on ability to lead a group of individuals and various cross-functional project teams on collaborative projects and the ability to work as a member of a team.
  • Effective verbal and written communication skills.
Special Requirements:
  • Advanced understanding of disciplined product development processes, good manufacturing practices, process validations and regulatory and quality requirements.
Preferred Requirements:
  • Experience in the medical device field.
  • ASQ Certified Quality Engineer preferred.
Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor. Click here to apply for this position.

 



1099 Clinical Support
Duties and Responsibilities
  • Basic Vertebral Augmentation case coverage support
  • Operating Room experience
  • Assist in referral /Market Development
  • Other duties to assist Sales Manager
Requirements
  • Fundamental understanding of spinal anatomy
  • Fundamental understanding of procedural imaging
  • Experience working in a sterile clinical setting
  • Ability to effectively and efficiently communicate verbally
Optimal Requirements
  • Certificate in Medical/Technical program or Associate degree or equivalent
    • Radiology/Surgery
    • Other
  • Experience supporting the clinical application of medical devices

Click here to apply for this position.




Director of Clinical Affairs
Position Summary:
Primary responsibility is for the management, direction and strategic development of clinical studies and clinical affairs personnel in support of Company goals and objectives. Function as contact person for all issues related to on-going or proposed clinical studies, or the resources required to support such studies. Develop business relationships with clinical investigators and their staff.

Authorities:
Has authority to make decisions and implement programs/action items within the specific province of clinical sciences.

Duties and Responsibilities:
  • Manage the clinical department:
    • Staff and manage clinical affairs department personnel
    • Budget planning, head count, hiring, training, documentation
    • Planning of quarterly and annual objectives
    • Measure and report clinical metrics
    • Ensure that the department is on track with the clinical objectives weekly
    • Weekly staff meeting planning
    • Manage team in positive manner, minimize turn-over, team oriented
    • Outsource appropriate tasks as needed (i.e., independent CRAs/CROs, statistics, medical writers)
  • Oversee all sponsored clinical trials and registries:
    • Maintain working relationships with all Principal Investigators and site clinical study personnel
    • Collaborate in authoring of clinical protocols o Develop and implement the DFINE STAR Registry
    • Develop and periodically review and refine clinical research related SOPs
    • Ensure development of all materials necessary to run the clinical trials (case report forms, investigator brochures, monitoring plans, etc.)
    • Create and foster clinical site relationships, submission of protocols, negotiation of contracts and budgets, performance of study cases, and completion of subject follow-up
    • Ensure adequate support to all sites with IRB/EC and contract approvals (including legal review) and annual reports
    • Ensure that all sponsored trials adhere to the appropriate legal, ethical and corporate requirements, as well as complying with local, national and international regulatory requirements and standards including FDA regulations to support US and international regulatory submissions
    • Collaborate in developing and executing the company’s clinical publication strategy, including manuscripts, meeting abstracts, and book chapters
    • Provide and adhere to project management timelines for trial completion, data collection, analysis and publications
    • Ensure the Sales team is aware of, and when necessary trained on, DFINE clinical trials and STAR Registry
    • Other duties as assigned
  • Clinical liaison to other department / project teams. Specific examples include:
    • Collaborate and coordinate activities with OUS clinical personnel (GmbH and distributors)
    • Marketing support to ensure accuracy of marketing literature, physician and patient labeling (brochures, booth graphics)
    • RA/QA support by reporting of clinical studies in support of regulatory submission and product certifications, adverse event reporting, clinical trial complaints
    • Reimbursement support via reporting of trial data o Support sales training clinical data related content
    • Provide monthly, quarterly and annual clinical objectives updates for intra-departmental and management review
    • Provide clinical study/registry metrics for monthly review
    • Conduct Investigator meetings as required for sponsored trials
    • Attend relevant scientific/medical meetings as needed
    • Maintain current on clinically related literature

Position Requirements:
  • BA/BS Degree. MS or PhD degree preferred with emphasis in life sciences, medicine, or related field
  • Preferred 5-10 years experience in management of clinical affairs group in a medical device company
  • Excellent written & oral communication skills
  • Proficient with MS Office Suite Applications
  • Basic clinical research statistical method experience
  • Thorough understanding of Good Clinical Practices, ICH and applicable regulations regarding research and regulation of medical devices

Requirements:
Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor.