JOB DESCRIPTION
Summarized Purpose:
Performs site management and other related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and PPD SOPs. Reviews study data from various sources remotely. Develops collaborative relationships with investigational sites and other stakeholders as applicable. May contact study sites to collect study documentation, resolves issues and requests outstanding information. Detailed tasks and responsibilities assigned to RSM-Central or RSMLocal positions are outlined in the task matrix. Works proactively and almost independently, requiring minimal supervision. Supports the line manager to mentor, train and contribute to the development of junior clinical team members.
Essential Functions:
. According to the specific role (Central or Local) may coordinate, oversee and complete assigned trial activities as detailed on the task matrix, including but not limited to the following:
. Develops and maintains a close and collaborative communication with the site staff. Actively discusses protocol conduction, enrollment rates and strategies, open issues, EDC completion and queries, as well as any other topic or indicator associated to project status and site performance.
. Completes/tracks/follows up ETRTR for subject data present in the EDC and other applicable systems, according to the study-specific guidelines. Raises manual queries in EDC when applicable.
. Remotely reviews study logs as deemed necessary.
Interested to apply can share CV to in*o@om**********h.com or for the zoom Screening ,Interview call/whatsapp to 9344064***.
Keyskills: qa audit site audits clinical trial audits sponsor audits