Job DescriptionCompany Name: PPD Development, L.P.Position Title: Clinical Data Team LeadLocation: 929 North Front Street, Wilmington, NC 28401Summary of Duties: Act as the lead data manager for one or more projects or to provide support to the lead data manager. Lead all data management activities for individual, limited volume and complexity studies with support from senior team members. Act as an interdepartmental and client liaison for all data management study activities. Apply relevant components of the project protocol to daily tasks and direct others on how to apply to their daily tasks. Act as a liaison to the project lead and client as required, and communicate with management regarding all data management (DM) activities within their studies. Develop and maintain data management project documentation files. Perform independent reviews of data management deliverables following documented CDM guidelines. Develop and deliver study specific training for DM project staff. Produce project-specific status reports for management, Project Lead and clients on a regular basis. Monitor study metrics. Participate in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required. Assist with project forecasting of hours and identification of resource requirements. Identify potential out-of-scope activities and projects to lead and manage. Assist with the contract modification process. Mentor junior level staff on all associated tasks within a study. Assist with the administrative and financial management of allocated projects. Perform all assigned data management activities independently and efficiently, with attention to quality. Duties may be performed remotely.Qualifications: Bachelor’s degree in Pharmaceutical Science, Clinical Research Administration, Health Informatics, Data Analytics, or related field and two (2) years of experience as a Research Data Manager, Clinical Data Manager, Safety Specialist, or related field. Must have two (2) years of experience with: Regulatory guidelines and SOPs; Interactive computer programs, including Excel, Microsoft Office, PDF, Docusign; Electronic Data Capture Systems (EDC or clinical databases) such as Medidata Rave; Designing and validating clinical databases, including designing or testing logic checks; Developing project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and workflow processes; and Designing forms for receiving, processing, or tracking data.#LI-DNIThermo 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.
