Endologix, Inc

Clinical Monitoring Manager

Job ID
2017-1758
US-CA-Irvine

Overview

 

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

 

Design, plan and conduct clinical research trials while effectively managing the activities of clinical affairs specialists/staff, study investigators, site coordinators, clinical research organizations (CROs), contractors, and regional monitors. Oversees and ensures compliance with study protocols, FDA and International regulations, IRB and/or Ethics committee’s requirements and overall clinical objectives.

 

In accordance with Endologix’s policies and applicable laws and regulations: Select, reward, discipline, train and develop employees.

Plan and direct performance of Clinical staff members as assigned: Motivate employees, assist in goal setting, provide development opportunities and performance feedback, address complaints and resolve problems.

Responsibilities

  • Oversee CRO management (contract F-CRA’s), site monitoring, data collection and its integrity, and deliverables
  • Ensure timely processing and review of clinical trial documentation including patient data, site files, safety data oversight and compliance of overall trial documentation
  • Partner with clinical team regarding the implementation, maintenance and improvement of policies and procedures pertaining to investigational trial monitoring
  • Establish and track quality performance measurements
  • May perform role of guest auditor or subject matter expert during clinical audits/inspections to assess accuracy and quality of scientific data submitted to Food and Drug Administration (FDA ) in support of Pre-Market Approval Application (PMA) or 510K for medical devices
  • Oversee and coordinates field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
  • Develop and deliver technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
  • Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, and data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.
  • Contribute to the development of clinical protocols, informed consent forms, and case report forms. Also contribute to team projects.
  • Manages assigned Clinical Affairs specialists directly
  • Manages regional monitors and other contractors per the project requirements.
  • Perform other duties as assigned by supervisor.

Qualifications

  • Knowledge of FDA regulatory requirements related to the conduct of clinical studies.
  • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Minimum Education:

  • Bachelor’s degree in a scientific discipline, RN or BSN degree or equivalent                                                                    

Minimum Experience:     

  • Minimum of 8 years’ experience in Clinical research with Bachelor’s Degree
  • Supervisory experience preferred
  • Experience with Medical Devices is preferred

Specific Skills, Knowledge & Behaviors

 

Core Competencies:

Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.

Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.

Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.

Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; Manage multiple tasks and competing demands; Change approach or method to best fit the situation.

Organizational & People Development: Function as both team player and leader; Provide informal feedback; Challenge the status quo; Strive for continuous professional development; Recognize the contributions of others; Set and achieve challenging goals.

Spoken Communication: Speak clearly and concisely; Listen carefully and seek clarification; Deliver effective presentations.

Written Communication: Write clearly and informatively; Create documents that are complete and accurate.

Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.

Decisions: Make timely and sound decisions; Take risks and manage them intelligently.

Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.

Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

 

Equipment Use & Abilities Required:

 

 

Equipment Use: Copy machines, fax machines, calculators and personal computers and computer terminals.

Computer Skills: Software proficiency in Microsoft Office Suite.

Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.   Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.  

Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

 

WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

 

The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.

 

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

                                            

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

                                                                                                                  

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