Job Overview
We are seeking a dedicated Clinical Systems Implementation & Validation Engineer for a contract position in Palo Alto, CA. This role requires a collaborative individual to engage with cross-functional teams in executing essential Computer Systems Validation (CSV) activities, including the assessment and testing of computerized systems. The position involves debugging and Silicon Validation, with a crucial focus on developing and reviewing test cases to ensure they align with organizational requirements.
Key Responsibilities
- Implement and categorize compliant Computerized Systems utilizing a risk-based methodology for clinical applications.
- Create and evaluate Change Controls pertinent to the implementation and upgrading of Clinical applications.
- Conduct and review release impact assessments to facilitate SaaS vendor releases (BSI and Veeva).
- Formulate and critique project plans aimed at enhancing clinical systems.
- Design validation strategies for critical integrations of Clinical Systems to ensure the availability of study data in CTMS from sites.
- Author, review, and endorse validation documentation deliverables, including Validation Plans, URS/FRS, and Qualification Plans.
- Instruct Test Script authors and test executors on performing PQ/UAT executions in Azure DevOps, in alignment with Client Qualification Management SOPs.
- Develop Data Migration Plans that incorporate data verification methods for archiving CRO eTMF files.
- Oversee and approve Periodic Review reports and collaborate with vendors on documenting system maintenance activities.
- Analyze Master Service Agreements and perform gap analysis against client policies to address procedural discrepancies.
- Execute Root Cause Analysis (RCA) using 5 Whys and fishbone methodologies for deviations, implementing Corrective and Preventive Actions (CAPA) and effectiveness checks.
- Serve as an IT Scribe during Mock Audits to facilitate communication between Front and Back rooms.
Required Skills
- Proficient experience with Clinical Systems (Veeva).
- Familiarity with Computer Systems Validation (CSV); CSA knowledge is advantageous.
- Expertise in Electronic Data Capture (EDC) systems, Veeva System, IRT, and CTMS.
- Comprehensive understanding of Data Management within Clinical Research Organizations (CRO).
- Strong grasp of Standard Operating Procedures (SOPs).
- Knowledge of Systems Integrations.
Qualifications
- A Bachelor's degree in a relevant discipline is preferred.
- Proven experience in Clinical Systems Implementation and Validation.
- Familiarity with CSV activities and electronic data capture systems.
Career Growth Opportunities
This role presents the chance to gain hands-on experience in clinical systems and validation processes, alongside the opportunity to work with cutting-edge technology. These experiences are fundamental for professional development in the life sciences and technology sectors, fostering career advancement.
Company Culture And Values
We pride ourselves on a collaborative and inclusive work environment that encourages open communication and teamwork. Our commitment to compliance and quality assurance highlights our dedication to maintaining the highest standards and accountability across all operations.
Networking And Professional Opportunities
By joining our team, you will have the opportunity to build a strong professional network, engage in skill development, and collaborate with talented individuals in the field, further enhancing your career prospects in this dynamic industry.
Employment Type: Contractor