Matrix Medical Network Job - 41728639 | CareerArc
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Company: Matrix Medical Network
Location: Scottsdale, AZ
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

 

Quality Assurance Manager, DCT (Remote)

 

Matrix Clinical Trials provides rapid and scalable decentralized trial solutions to reach broad and diverse trial participant populations and improve the patient experience. Matrix adheres to the highest standards in quality, compliance, and data collection to accelerate trial completion timelines and support trial partners.

 

To learn more about Matrix Medical Network Clinical Trials please visit:  https://matrixmedicalnetwork.com/clinical-trials/ 

 

 What we offer:

    • A chance to work with great people on exciting projects
    • Make a difference by taking the time doing the work that saves lives that have positive and direct impact on the wellbeing of others
    • The opportunity to work with a progressive company, who wants to make a difference
    • Opportunities to travel
    • Matrix Medical Network is proud to be a Diversity, Equity and Inclusion Employer  


Qualifications

 

Educational Requirements:

A Bachelor of Arts /Science degree or related field is required.

A Combination of Education and Work Experience May Be Considered. (Required), Bachelors

Registered Quality Assurance Professional (RQAP), Certified Quality Auditor (CQA), Certified Clinical Research Associate (CCRA), Certified in Research Healthcare Compliance (CHRC) or equivalent is a plus.

 

Required Skills and Abilities:

The ideal candidate will possess a strong understanding of the clinical trials, virtual care and healthcare industry and specifically with decentralized clinical trials. We are looking for a business professional with 5-10 years of  clinical research quality assurance, CRO or pharma operations experience. The successful candidate will possess the following experiences and personal attributes:

Knowledge

  • Strong working knowledge of Microsoft Office and clinical research Quality Management Systems (QMS, eSource, CTMS, eReg, EDC, etc.).
  • A good understanding of what it takes to ensure clinical research quality assurance
  • Must be comfortable working independently to achieve defined financial and operational goals.

Experience

Knowledge, Skills and Abilities:

  • 5+ years experience leading and overseeing clinical trials quality and compliance.
  • 5-10 Years experience in clinical trials, Pharma, CRO or related field
  • Excellent communication skills with Leadership, outside partners, and international organziations. Ability to relate to physicians, nurses, and senior level health care leaders
  • Excellent presentation skills
  • Excellent interpersonal and patient centric skills to interact effectively with co-workers and outside partners
  • Expert quality management skills, including the developing and maintaining detailed quality management plans, and experience prioritizing work and meeting deadlines.
  • Extensive knowledge of project management processes, systems development methods, organizational change management concepts, and business process improvement methods.
  • Expert ability to work with others in order to achieve a common goal, resolve conflicts and manage cross-functional and external relationships; demonstrated ability to negotiate and influence without authority.
  • Ability to analyze complex problems, interpret quality needs and develop creative solutions in a technical environment.
  • Strong interpersonal skills, including the ability to make effective written and oral presentations, work well with different types people in a multi-cultural environment and matrix organization..
  • Experience with government agency inspections and external Pharma/CRO auditors.
  • Experience working in multi-client and multi-vendor environments.
  • Ability to coordinate complex logistics
  • Demonstrated ability to handle multiple priorities which may involve competing deadlines
  • Strong organizational skills with proven track record of excellence
  • Prior experience working in cross-functional teams
  • Proven ability to set goals and deliver results against KPIs
  • Must be a proactive, team-focused leader and self-starter .
  • Proven track record working with international clients; excellent client interface and customer service skills.
  • Ability to work effectively in a fast-paced, entrepreneurial environment and build programs to scale.
  • Superior leadership skills with the ability to influence and engage others; direct and non-direct reports and peers.
  • High level of integrity with a hands-on work ethic and approach.
  • Business and organization knowledge.
  • Teamwork building skills.
  • Quantifiable business results.
  • Service oriented (External and Internal).
  • Flexible and adaptable.

 

Our Culture: 

 

  • We have a clear vision of where we are going, and we are guided by core values that embody our organization and our culture.
  • We emphasizes innovation and growth, and you will be given the opportunities and tools to develop personally and professionally.
  • We encourage and celebrate collaboration.
  • We have a deep commitment to positively impact the communities in which we work and to make a difference in the lives of who we serve.
  • As a clinical organization, we support vaccinations because we care about the health and safety of our colleagues and those we serve. Moreover, our clients are increasingly expecting us to be vaccinated due to the vulnerability of those we serve.  As such, Matrix Medical Network requires that all team members are fully vaccinated against Influenza and COVID-19, unless they are eligible for a specific exemption.

 

Matrix Medical Network is an Equal Employment Opportunity Employer. It is the policy of Matrix to provide equal employment opportunities without regard to race, color, religion, sex, gender identity or expression, pregnancy, age, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law. It is also the policy of Matrix that qualified individuals with disabilities receive equal opportunity in regard to job application procedures, hiring, and all aspects of the employment process. Matrix is committed to the full inclusion of all qualified individuals. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of Matrix to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship.  If reasonable accommodation is needed to participate in the job application or interview process, pre-employment testing, to otherwise participate in the selection process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact MatrixHR@matrixhealth.net.

 

  

Matrix Medical Network is proud to be an Equal Opportunity Employer. Scottsdale, AZ 85258, Remote, Primary Location: Scottsdale, AZ 85258.  Job: Manager, Quality Assurance, DCT,  Regular Shift. Full Job Level: Day Job,  Travel, Monday, Friday. Job, work at home opportunity, DCT, clinical trials, ACRP, CRC, clinical trials research, CRO, management,  Remote Opportunity, Regular, Job Type, Standard, Travel, Pay, hours.    

 

 



Responsibilities

About the Position:

 

     Type: Full Time Regular

     Compensation: $86,000 - $100,000 Base + Eligible for 10% STI management bonus  

Location: Primary location is 9201 E. Mountain View, Road, Scottsdale, AZ 85258. Position is remote.  

Hours: Days, Evenings, occasional weekends and flexible  

Benefits Offered to include: Medical, Dental, Vision, 401K with company matching, paid time off, paid holidays and eligible for tuition discount to name a few. 

 

The Manager Quality Assurance, DCT is responsible for ensuring quality and compliance with regulations, guidances and Matrix Clinical Trials policies and procedures.  This role is a key leader in the deployment of solutions to advance the corporate mission of Matrix clinical trials. This role requires strong leadership skills, clinical research quality management expertise and the ability to work clinical and business unit leaders to support the goals of safeguarding patient safety, regulatory compliance and data integrity. 

  • Schedule, oversee and perform routine and non-routine quality assurance audits including, but not limited to: study decentralized sites, vendors, processes, and systems
  • Manage and maintain databases for the quality system
  • Prepare and assist in preparing quarterly/annual reports and quality trending reports
  • Preside over improvement programs
  • Evaluate quality events, incidents, queries, and complaints
  • Keep up to date with all applicable quality legislation and compliance issues
  • Utilize guidance documents, international standards, or consensus standards and interpret for guidance
  • Provide regulatory and GCP oversight and support internal staff
  • Assist Education department in the development of education and training activities including but not limited to regulatory compliance and GCP, as needed
  • Assist Clinical Operations and other functional units in the development and review of SOPs and other quality documents
  • Develop and implement detailed audit plans
  • Ensure timely and effective follow-up of all identified or assigned quality issues
  • Assist in preparing investigational sites for regulatory inspections
  • Presides over audits
  • Assists with Research Quality & Regulatory Compliance Committee
  • Assume a lead role for the preparation, conduct, and responses to regulatory agencies
  • Communicate any critical compliance risks noted from these activities to senior management 


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