Staff Clinical Data Manager

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.

• Lead Clinical Data Management operational activity of clinical trials in sample collection, clinical validation, and reproducibility studies
• Draft data cleaning and review plans under Good Clinical Practices (GCP) and SOPs including, but not limited to data listings review, data query management and external party data reconciliation
• Accountable for development and upkeep of key project CDM deliverables (Data Management Plans, Data Transfer Agreements, etc.)
• Responsible for Clinical Data Management Electronic Data Capture (EDC) development and validation of Case Report Forms (eCRF) per study protocol
• Primary point of contact across Clinical Affairs, Biostatistics, Product Test Groups, and Field Application Engineers for data reconciliation
• Review and update overall study timeline deliverable dates in collaboration with Manager, Clinical Data Management

• Bachelor’s degree or above in a Biomedical, Life Science, or Engineering discipline preferred
• Intermediate coding proficiency in database development environments (MySQL, SQL Server, preferred)
• Proficient in computer skills for communication and reporting (Microsoft Office, JIRA, Confluence)
• Strong collaboration skills with internal clinical personnel and external sites or vendors
• Knowledge of clinical/medical terminology
• Experience of Software Development Life Cycle (SDLC) particularly in software validation and verification
• GCP and regulatory knowledge including FDA and IVD regulations

• Minimum 4 years of relevant experience in Clinical Data Management in a Pharmaceutical, Biotech, or CRO environment.
• Experience project leading with multiple deliverables on standardized timelines
• Experience working on projects managing a clinical database environment, preferred
• Experience with clinical trial databases and electronic data capture (EDC)
• Experience with laboratory information management systems (LIMS)
• Working knowledge of FDA regulations, IVD GCP guidelines, SDTM, CDISC, database development and UAT
• Working experience and understanding of Oncology diseases and clinical research

The estimated base salary range for the Staff Clinical Data Manager role based in the United States of America is: $113,600 - $170,400. 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 accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf