Remote Clinical Research Manager
Company: PPD Development, LLC
Posted on: September 16, 2021
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
-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
-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 /
Keywords: PPD Development, LLC, Wilmington , Remote Clinical Research Manager, Other , Wilmington, North Carolina
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