"Senior Executive/Assistant Manager (Study Monitor)"

Job Description

We are looking for an experienced clinical monitor to perform the study monitoring in ADVANcing Clinical Evidence in Infectious Diseases Network (ADVANCE ID). ADVANCE ID is jointly funded by the Wellcome Trust and Singapore institutions including the Saw Swee Hock School of Public Health and Yong Loo Lin School of Medicine, National University of Singapore. The vision of the Network is to improve public health by developing the clinical evidence base for the prevention and treatment of drug-resistant infections. Its mission is to build and sustain a strategic clinical research network focussed on most efficiently delivering locally relevant interventions for drug-resistant infections.

The Network aims to improve and strengthen clinical research capabilities in the region by acting as a platform to develop good principles and practices. It will stabilise capacity and capabilities to mitigate inefficiencies in trial start-up phase and loss of skillset following study closure, as in typical trial setup. The Network will continuously develop its capabilities, quality and efficiency by learning from and collaborating with other clinical trial networks.

In the long term, the Network aims to support broader infectious disease studies by expanding geographically beyond its original starting point in South East Asia and collaborating with other networks around the world. It will function as an active network that involves patients in platform trials, allowing for rapid clinical research response in the event of an emerging infectious disease or pandemic threat.

The monitor should be able to supervise study sites and activities to ensure adherence to appropriate study protocols and applicable regulatory requirements of the study.

Duties & Responsibilities

• Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit reports.
• Monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
• Evaluate the quality and integrity of the reported data, site efficacy and investigational product (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 meet enrolment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory 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 as appropriate.

Qualifications

• Site Management or equivalent experience in clinical research, with understanding of clinical 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 limited oversight.
• Good time management and ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
• Strong computer skills, including but not limited to the knowledge of an electronic data capture systems (EDC), Electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), and MS-Office products such as Excel and Word.
• BSc or MSc in rele