Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve! We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.

Position Summary:

As the Senior Clinical Data Manager you will join our rapidly growing Companion Diagnostics Program and contribute key support and expertise to our analytical validation and clinical studies. With a focus on detail, you will play a critical role in designing and executing approaches for leading clinical data. You will collaborate with clinical operations, statistics, and data science personnel as well as external partners to ensure accurate, documented, and regulatory-compliant data from studies pivotal to the ArcherDX platform.

This role reports to the Senior Director Clinical Development & Operations and may be located Remotely.

Responsibilities:

Job performance will involve a variety of activities including:

• Collaborate with our pharma partners and CROs to lead ongoing data cleaning, data locks, and provide support for data analysis
• Develop, execute, and maintain robust and compliant data management plans
• Review and assist with development of data transfer agreements and data specifications
• Recognize process improvement needs and collaborate with other personnel to address them
• Draft data reports for regulatory filings
• Contribute to the development and implementation of departmental policies, standards, and protocols
• Review, understanding, and compliance with HIPAA Security policies and procedures.
• Safeguarding the privacy and security of protected health information and European Union personal data.

Experience:

• Bachelor's degree with a major in a scientific or other relevant field
• 2+ years of clinical data management experience in a life sciences organization
• Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software
• Experience working with medical devices, diagnostics, and/or oncology assays preferred
• Familiarity with molecular biology, genetics, and genomic sequencing preferred
• Familiarity with CDISC standards including SDTM preferred
• Experience with Electronic Data Capture (EDC) software preferred
• Outstanding organization skills and attention to detail
• Ability to work collaboratively and to communicate effectively with team members
• Highly motivated and self-directed

Key attributes

• Drive and determination
• Thrives in a fast paced, dynamic environment

In Colorado, our competitive compensation package includes a base salary starting from $134,000 per year. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.

Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:

• Health, dental, vision, short- and long-term disability, and basic life insurance coverage
• Paid time off, holiday pay, parental leave, and other health and wellness supports

At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.