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Remote Clinical Research Manager

Company: PPD Development, LLC
Location: Wilmington
Posted on: September 16, 2021

Job Description:

Insight Global is looking for a Clinical Research Manager to join the team sitting fully remote in support of a Government customer focusing on infectious diseases. The CRM will be responsible for the following:



-Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.

-Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.

-Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.

-Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.



-Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)

-Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Keywords: PPD Development, LLC, Wilmington , Remote Clinical Research Manager, Other , Wilmington, North Carolina

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