clinical data manager

clinical data manager San Diego, CA

Illumina
Full Time San Diego, CA 66724 - 45383 USD ANNUAL Today
Job description

What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Responsibilities:
  • Execution of Quality Management Systems(QMS) transactions in ERP system including but not limited to material control and master data
  • Provide quality review and approval of equipment management documentation
  • Builds and maintains relationships with the teams supported
  • Review and improve quality master data to align with released standards
  • Apply global governance of quality system controls in SAP to existing data fields.
  • Support QMS projects to ensure compliance to applicable regulations and standards
  • Provide feedback on documents and systems to improve standard activities efficiency and effectivity
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Review data for compliance to specifications and report abnormalities
  • Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
  • 0-2 years’ experience in data management or quality field in a regulated environment; direct experience working in quality data management preferred
  • Ability to understand and follow work instructions
  • Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint)
  • Self-starter, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
  • GMP experience a plus
  • Knowledge and experience applying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD) Knowledge and experience with instituting quality controls in an ERP system, SAP preferred
  • Highly effective communication, facilitation and negotiation skills
  • Adaptable to fast-paced, dynamic work environment with shifting demands
  • All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities
Experience/Education:
  • 0-2 years’ experience in data management or quality field in a regulated environment; direct experience working in quality data management preferred
  • BS degree; or equivalent work experience
The estimated base salary range for the Quality Data Associate role based in the United States of America is: $46,000 - $69,000. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

clinical data manager
Illumina

www.illumina.com
San Diego, CA
Charles Dadswell
$1 to $5 billion (USD)
5001 to 10000 Employees
Company - Public
Biotech & Pharmaceuticals
1998
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