Thermo Fisher Scientific is looking for a Manager of Lab Data Management to prepare and review data management documents to meet or exceed quality expectations, interact with the laboratory to determine the format and design of complex data management documents for potential submission to regulatory authorities, use data entries and information to develop report text, and ensure compliance with required formats. This role also serves as a departmental resource for training, mentoring, and the development of process improvements.
Requirements
- 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).
- Good working knowledge of scientific terminology, medical, pharmaceutical, and research concepts.
- Working knowledge of data management procedures and regulatory requirements.
- Proficient with Microsoft Office.
- Strong editorial/proofreading skills.
- Clear understanding of broader GMP labs testing process.
- Good understanding of challenges of lab data used in GMP.
Responsibilities
- 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.
- Organizes processes for data management documentation.
- Ensures compliance with internal and external policies and procedures on publications.
- Keeps updated on guidelines and requirements of regulatory agencies to ensure that information is available for staff.
Other
- Supervises daily work activities of the data management staff to ensure efficient and effective operations.
- Provides short-term 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).
- Ensures that staff are in compliance with documented procedures to ensure quality expectations are met.
- Represents the data management team in overall initiatives and collaborates with other department heads on process improvements.
- 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.
- Strong time management and project management skills.
- Excellent written and oral communication skills.
- Strong attention to detail.
- Proven problem-solving and troubleshooting abilities.
- Demonstrated leadership abilities.
- Ability to motivate and train staff individually and in a team environment.
- 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.
- 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.
- 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.
