Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

This is a fully remote role supporting our GMP Lab in Middleton, WI. We welcome applicants from all locations within the US.  

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.

Location/Division Specific Information

Our GMP Labs 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.

Discover Impactful Work:

The Manager of Lab Data Management prepares and reviews data management documents to meet or exceed quality expectations. This position interacts with the laboratory to determine the format and design of complex data management documents for potential submission to regulatory authorities. The Manager uses data entries and information to develop report text and ensures compliance with required formats. This role also serves as a departmental resource for training, mentoring, and the development of process improvements.

A day in the Life:

Supervision and Resource Planning:Supervises daily work activities of the data management staff to ensure efficient and effective operations.Provides short and long-term resource planning to assign projects to appropriate and available staff.Evaluates the timeliness and quality of deliverables and provides updates to senior management, including the tracking of key performance indicators (KPIs).Document Preparation and Review:Ensures that staff are in compliance with documented procedures to ensure quality expectations are met.Prepares and/or assists in the preparation of data management documents such as methods, protocols, reports, summaries, and standard operating procedures (SOPs).Compiles laboratory data into specified formats and ensures that hardcopy and electronic reports are consistent and comply with required formats.Edits and performs quality control review of reports prepared by data management staff. Reviews data tables and listings to ensure accuracy.Process Organization and Improvement:Organizes processes for data management documentation.Ensures compliance with internal and external policies and procedures on publications.Represents the data management team in overall initiatives and collaborates with other department heads on process improvements.Keeps updated on guidelines and requirements of regulatory agencies to ensure that information is available for staff.Training and Mentorship:Provides assistance and resource information to departmental and laboratory staff.Trains and mentors other data management and laboratory staff in documentation skills and procedures for preparing documents.Assesses the competency of staff in the unit and issues formal evaluations.

Keys to Success:Education·Bachelor's degree or equivalent and relevant formal academic/vocational qualification

ExperiencePrevious experience (5+years) in a related field.Understanding of laboratory scientific data and their systems such as laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), and scientific data management systems (SDMS).1+ year of leadership responsibility.

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.

Knowledge, Skills, AbilitiesGood working knowledge of scientific terminology, medical, pharmaceutical, and research concepts.Working knowledge of data management procedures and regulatory requirements.Strong time management and project management skills.Excellent written and oral communication skills.Proficient with Microsoft Office.Strong attention to detail.Strong editorial/proofreading skills.Proven problem-solving and troubleshooting abilities.Demonstrated leadership abilities.Ability to motivate and train staff individually and in a team environment.Clear understanding of broader GMP labs testing process.Good understanding of challenges of lab data used in GMP.Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.Good interpersonal skills with an internal and external customer focus.Capable of leading and mentoring junior level staff.Proven flexibility and adaptability when working in a team and independently using good judgment in making decisions.Strong computer skills and knowledge of databases and how to effectively extract and interpret data.Ability to maintain a high degree of confidentiality with GMP data and client’s proprietary data.Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to work upright and stationary and/or standing for typical working hours.Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.Moderate mobility required.Ability to access and use a variety of computer software developed both in-house and off-the-shelf.Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Frequently interacts with others, relates sensitive information to diverse groups.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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