Study Manager

1 week ago

Singapore Consortium for Clinical Research and Innovation Singapore Full time

**Overview**

The Consortium for Clinical Research and Innovation, Singapore (CRIS) brings together five national R&D, clinical translation and service programmes to advance clinical research and innovation for Singapore, and establish important capabilities for a future-ready healthcare system.

The Business Entities under CRIS include:

- Singapore Clinical Research Institute (SCRI)
- National Health Innovation Centre (NHIC)
- Advanced Cell Therapy and Research Institute, Singapore (ACTRIS)
- Precision Health Research, Singapore (PRECISE)
- Singapore Translational Cancer Consortium (STCC)
- Cardiovascular Disease National Collaborative Enterprise (CADENCE)

Together, CRIS makes a positive difference to Singapore patients and researchers by ensuring that these clinical research platforms and programmes are at the cutting edge of capability development and innovation. If you are as passionate as we are in clinical trials and research, we want you

**SCRI**

The Singapore Clinical Research Institute (SCRI) is the national coordinating body (NCB) for clinical trials with a vision to establish Singapore as a regional thought leader in clinical research. This is accomplished through the deployment of innovative technologies and processes, and strategic coordination of ecosystem capabilities and infrastructure to achieve synergies that will enhance the clinical research ecosystem aimed towards a healthier community and better patient outcomes.

**What you will be working on**

**The Role:
You will be responsible for planning, monitoring and coordinating of clinical trials within the region. Your responsibility will include:

- Collaborate with Study Management Team to drive patient recruitment and successful execution of clinical studies.
- Independently perform site qualification, site initiation, site routine monitoring, site management and site close out visits ensuring GCP/ICH/protocol compliance.
- Work with site personnel and study team to prevent, mitigate and resolve issues.
- Document monitoring activities in monitoring reports, follow-up letters and other required documentation as per SOPs and site monitoring plan.
- Review Informed Consent process documentation, conduct source document review and source data verification of CRFs, DCFs, as stipulated.
- Ensure the reporting of high quality data and timely query resolution
- Ensure that the site is reporting safety events appropriately and in a timely manner.
- Process SAE reports and perform reconciliation.
- Organize, present at and participate in Investigator Meetings, other study trainings and meetings as required
- Assist investigator in IRB/EC &RA submission.
- Manage trial financial payment including site payments.
- Coordinate with sites in preparation for study site audits and in providing responses to audit findings as stipulated.
- Assist in the review of CRF design & CRF completion guidelines.
- Provide training for training events organized by SCRI Academy as required.

Requirements:

- Degree in Health Sciences/Nursing/Pharmacy/Clinical Research/related field.
- At least 3 years of experience in clinical trial
- For senior CRA, preferable with Phase I monitoring experience
- Those with clinical research monitoring experience in a Pharmaceutical Company or a CRO will have added advantage
- Have some knowledge of clinical trial monitoring, drug development process, GCP, regulatory requirements of regional countries, basic knowledge of project management and medical terminology.
- Have strong communication, time management and interpersonal skills.
- Ability to take initiative and work independently.
- Be proficient in English and have good writing skills.
- Be able to travel
- Be organized and have attention to detail
- Have a professional appearance and demeanor

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