Assistant Manager (Study Monitor)

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Job Description

•Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) andtermination visits (TV) at assigned clinical sites and generate visit reports.
•Monitor the progress of clinical study sites participating in a clinical study, and toassure the protocol is followed and data is reported accurately.
•Evaluate the quality and integrity of the reported data, site efficacy and investigationalproduct (IP) management.
•Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
•Develop patient recruitment strategies in conjunction with the clinical site to meetenrolment timelines, while also ensuring compliance with the approved standardoperating procedures (SOPs), protocol/amendment(s), GCP, and the applicableregulatory requirement(s).
•Assure that adverse events are correctly documented and reported.

•Ensure proper transmission of clinical case data to the data management centers,review case reports questions and problems and clarify or obtain alterations to data asappropriate.

Qualifications

•Site Management or equivalent experience in clinical research, with understanding ofclinical trials methodology and terminology.
•Ability to perform all clinical monitoring activities independently.
•Strong interpersonal, written, and verbal communication skills within a matrixed team.
•Experience working in a self-driven capacity, with a sense of urgency and limitedoversight.
•Good time management and ability to manage multiple tasks, evaluate a variety ofunpredictable scenarios and achieve project timelines while being able to apply yourunderstanding of study protocol(s).
•Strong computer skills, including but not limited to the knowledge of an electronic datacapture systems (EDC), Electronic Trial Master File (eTMF), Clinical Trial ManagementSystem (CTMS), and MS-Office products such as Excel and Word.
•BSc or MSc in relevant field. A lower educational credential may be considered ifcandidate has ample monitoring experience.