Sr. Clinical Data Manager at Invitae

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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
  • 5+ 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.

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Technology we use

  • Engineering
    • C#Languages
    • C++Languages
    • JavaLanguages
    • JavascriptLanguages
    • PHPLanguages
    • PythonLanguages
    • SqlLanguages

Location

Situated in Austin's Central Business District, one block West of the Texas State Capitol.

What are Invitae Perks + Benefits

Invitae Benefits Overview

At Invitae, our employees are the key to our continued success. Our culture is one of our most important strengths. A set of commitments we make to each other and to our customers to build a world-class organization in service of our mission. That is why Invitae proudly offers comprehensive perks and benefits program with choice and flexibility in mind.

Culture
Friends outside of work
Eat lunch together
Intracompany committees
Daily sync
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Unconscious bias training
Diversity manifesto
Someone's primary function is managing the company’s diversity and inclusion initiatives
Mean gender pay gap below 10%
Diversity Employee Resource Groups
Hiring Practices that Promote Diversity
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Team workouts
Mental Health Benefits
Retirement & Stock Options Benefits
401(K)
Company Equity
Employee Stock Purchase Plan
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Family Medical Leave
Adoption Assistance
Return-to-work program post parental leave
Vacation & Time Off Benefits
Unlimited Vacation Policy
Sabbatical
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Free Daily Meals
Game Room
Stocked Kitchen
Some Meals Provided
Happy Hours
Parking
Pet Friendly
Recreational Clubs
Home Office Stipend for Remote Employees
Professional Development Benefits
Job Training & Conferences
Diversity Program
Lunch and learns
Cross functional training encouraged
Promote from within
Mentorship program
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