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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Sr Project Co-ordinator (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

• Provide hands-on support including tracking, migrating, and verifying data and documents between various repositories (internal and/or external).

• Identify and map data across documentation and regulatory submissions.

• Manage documentation at various stages of lifecycle.

Process Analytics and Trending

• Proactive user of Power BI preferred.

• Identify key analytic themes/parameters and generate trending information to understand baseline framework, level of control, and improvement.

• Ensure effective problem analysis and timely resolution of diverse issues, escalating when necessary.

• Lead the identification and implementation of strategies to improve process, system, and result qualities and efficiencies.

• Maintain a strong understanding of compliance systems, current technologies, and professional concepts.

• Schedule and plan work to meet priorities, setting 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:

• Familiarity with CMC regulatory filing structures and supporting documentation required for submissions.

• Flexibility and adaptation to changing environments.

• Strong verbal and written communication skills.

• Experience with controlled document computer systems e.g. Veeva.

• Ability to communicate, influence and negotiate at various levels.

• Broad knowledge of the R&D Drug Development Process preferred.