Records Specialist

Thermo Fisher Scientific•Middleton, WI

12h•Onsite

About The Position

This is a fully onsite role based at our GMP Lab in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. The Records Specialist provides general global records management (GRM) and file room support by working closely with global project teams to ensure all global records management tasks are completed according to organization and/or client standard operating procedures (SOP) and working practice documents (WPD). This role also provides broad technical assistance to study teams.

Requirements

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Sophisticated communication and interpersonal skills
Excellent organizational skills and strong attention to detail with proven ability to handle multiple tasks efficiently and effectively
Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
Flexibility to reprioritize workload to meet changing project timelines
Firm understanding of applicable systems including document management software
Advanced computer skills
Excellent English and grammar skills, (second language a plus)
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Nice To Haves

Associate's degree preferred
Technical positions may require a certificate

Responsibilities

Process (scans/images, indexes, files) incoming study documents (paper and/or electronic).
Act as the study team subject matter expert on the filing process for assigned studies.
Liaise with the clinical study team to resolve outstanding issues identified during filing and/or quality reviews.
Provide extensive technical support for the study team when initiating the TMF.
Maintain and update products and systems associated with global records classification, retention and disposition.
Conduct training for department staff, company employees, and clients.
Assist with applicable sponsor deliverables.
Work independently on special projects

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