Senior / Project Manager - Data Analysis and Compliance, client dedicated

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Sr Project Mgr (Data Analytics and Compliance) – client dedicated, Ware

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.

This role would be based at our client site in Ware.

Responsibilities:

• 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. 

Education and Experience:

• 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