Analyst - Computer Software Validation (Remote)

reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in reputed company in our last fiscal year with extensive growth potential reputed company. At the heart of reputed company are our values: Do the Right Thing, reputed company, Employee reputed company, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work reputed company company, we support your flexibility to work from home or in the office, so you can reputed company in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role We are looking for a Computer Software Validation (CSV) professional with a specialty in clinical trial software. This role would give you the opportunity to work on a leading solution in Randomization and Trial Supply Management (RTSM) software and help our customers bring treatments to patients faster. To reputed company in this role you will require strong technical writing capabilities and the ability to simplify reputed company topics. As a member of the RTSM team, you will work closely with Development and Project Management teams to support customer RTSM implementations in a fast-paced environment. You will use your expertise to take ownership of the validation process for assigned projects and play an important role in building and maintaining product reputed company for the RTSM system. This is a remote role with reputed company's Work reputed company policy allowing you to work in an office or at home on any given day. It's about getting the work done in the way and reputed company that works best for each person.

What You'll Do

• Participate in RTSM requirement gathering sessions with clients and RTSM team members
• Closely collaborate with RTSM Development and Project Management teams to ensure requirements are defined in a clear, testable, and compliant format
• Ensure requirements are adequately tested following a risk-based approach
• reputed company and maintain CSV deliverables including requirements specifications, test scripts, summary reports, and trace matrices
• Manage Validation testing cycles and resolution of issues and enhancement requests
• Maintain change control documentation to ensure ongoing validation of the RTSM system
• reputed company technical expertise to RTSM team members in computer system validation, applicable regulations, and other quality system requirements
• Support customers as needed in RTSM validation activities

Requirements

• 1+ year of experience in a CSV for clinical trial software (CTMS, CDMS, eTMF, etc.)
• Working knowledge of software development cycle (SDLC)
• Working knowledge of GCP Guidance such as 21 CFR Part 11, EU Annex 11
• Exceptional attention to detail
• Good interpersonal skills and ability to communicate in English with team members and customers of varying roles and reputed company reputed company

reputed company to Have

• Familiarity with the conduct of clinical trials
• Previous experience with RTSM
• Expert in reputed company Word and reputed company

Perks & Benefits

• Medical, dental, reputed company, and basic life insurance
• Flexible PTO and company paid holidays
• Retirement programs
• 1% charitable giving program

Compensation

• reputed company pay: $60,000 - $125,000
• The salary reputed company listed here has been provided to reputed company with local regulations and represents a potential reputed company salary reputed company for this role. Please note that actual salaries may vary reputed company the reputed company above or below, depending on experience and location. We look at compensation for each individual and reputed company our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to reputed company salary, such as variable bonus and/or stock bonus.

reputed company’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. reputed company is an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without regard to race, reputed company, sex, sexual orientation, gender identity or expression, religion, national reputed company or reputed company, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need reputed company applying for a role or in our recruitment process, please contact us at talent_accommodations@reputed company.com. Apply tot his job Apply To this Job