Project Manager, Data Analytics and Compliance Labs - customer dedicated

• Day-to-Day Document/Data Migration
• Hands-on support as required including tracking, migrating and verifying data and documents between various repositories (internal and/or external)
• Create and perform data mapping for understanding appropriate categorization of data per project
• Report on obstacles and inefficiencies with recommendations for improvement
• Assignments may vary in size, duration and urgency, so flexibility and adapting to changing environments is likely to be required
• Process Analytics and Trending
• Identification of key analytic themes/ parameters and generation of any trending for understanding baseline framework, level of control and improvement
• On-boarding training/On-going training on client systems
• Application of knowledge and leveraging of continuous improvement activities utilizing available tools that support continued adherence with industry regulations
• Proactively communicates the status of critical compliance systems support and problem resolution.
• Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed
• Ensures lifecycle management that includes archiving controlled-issued documentation via the R&D archival system and other designated document repositories.
• Leads the identification and implementation of strategies to improve the qualities and efficiencies of processes, systems and results. Maintains strong compliance systems understanding of current technologies and professional concepts.
• Responsible for scheduling and planning their own work to meet priorities. Sets specific daily and weekly priorities to meet timelines.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills and Abilities:

• Experience within the pharmaceutical industry essential
• Proactive user of Power BI or other data analytics/visualisation software eg Spotfire (incl. data mapping, setup of sway pages etc)
• Familiarity with filing structures and documentation required for submissions
• Experienced in User testing ideally within the acquisitions environment
• Ability to move data quickly
• Compliance systems experience preferred
• Strong Project Management experience preferred
• Experience with Veeva Vault is strongly desired.
• Strong interpersonal skills required
• Strong verbal and written communication skills required
• Experience with controlled document computer systems required
• Keeps current on governmental regulatory requirements and the Client's standards related to biopharmaceutical clinical manufacture and control
• Experience with learning management systems preferred
• Ability to communicate, influence and negotiate at various levels
• Broad knowledge of the R&D Drug Development Process preferred

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. With $1.4 billion invested annually in R&D, our collaborative and diverse teams have the resources they need to drive new discoveries and do cutting-edge research and develop important applications and tools that help millions of lives around the world.
Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000+ colleagues deliver an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.