Assistant Study Manager

**Job Title**: Assistant Study Manager /Study Manager

**Department**: STCC - Clinical Trials and Investigational Medicine Units

**Business Entity**: STCC

**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)

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

**STCC**

The Singapore Translational Cancer Consortium (STCC) is a nationally coordinated consortium to
synergise cancer research capabilities in Singapore. Established in 2020, STCC brings together
unmatched basic, clinical and translational talent in Singapore to create globally significant peaks of
excellence in selected Asian cancers. STCC’s four joint platforms - Clinical Trials and Investigational
Medicine Units, Cancer Database and Tissue Banks, Research-based Molecular Diagnostics, and
Business Intelligence and Development Unit - provide an enabling research and innovation
environment driven to foster translational research with meaningful outcomes for society. We
currently have the following opening and would like to invite you to be part of an ongoing and dynamic
team.

**What you will be working on**

**The Role:
**The Assistant Study Manager / Study Manager (Clinical Trials) will be responsible for the duties and
responsibilities listed below:
**Primary Responsibilities and Duties**

Manage and liaise with Investigators on their interest in the feasibility requests received.
Perform appropriate trial feasibility assessment and determine risk mitigation strategies and

steps.
Prepare and review feasibility questionnaires, surveys and other feasibility-related

documents.
Create, maintain and update feasibility tracker and database
Evaluate, document and collect information on sites and other available facilities.

Contribute and manage processes related to continuous quality improvement and effective
feasibility evaluation and site identification.

Prepare and coordinate documents from relevant stakeholders for regulatory and ethics
submissions.

Manage the regulatory and ethics submissions and approvals for assigned clinical trials.
Manage the review and execution for the non-disclosure agreements, clinical trial

agreements, research collaboration agreements as well as manage and liaise with
pharmaceutical/biotech companies and sites on the budget negotiations.

Prepare, review and monitor the status of submissions/amendments for regulatory
authorities and ethics committees. Ensure adherence and compliance with regulation and
internal procedures.

Execute all start-up related activities.
Assist with the creation and review of the case report form and set up of database for

assigned clinical trials.
Liaise with stakeholders (sites, CROs and vendors) to set up invoicing and payment matters.
Arrange and coordinate STCC tumour groups related activities which include development of

documents and facilitation of meetings.
Update and maintain internal databases and tracking systems with project specific

information.
Assist in the review of the clinical trial protocol and study-related documents such as

pharmacy manual, laboratory manual, drug request forms, SAE forms, study file templates,
monitoring visit templates, etc.

**What we are looking for**

**Qualification**
Minimum Bachelor’s degree in life sciences, nursing, pharmacy, medical science or

equivalent preferred.

**Experience**

At least 3 years of experience in clinical research in a Pharmaceutical Company, or CRO

Possess knowledge of Good Clinical Practice (GCP), clinical trial monitoring, drug
development process, regulatory requirements, project management and medical
terminology.

Able to conduct literatures searches and interrogate databases.

**Skills**
Proficient in Microsoft Office e.g. PowerPoint, Word and Excel
Meticulous with an attention for details.
Excellent communication skills, both written and spoken.
strong communication, time management, analytical and problem-solving skills.
Ability to work independently and in a team.

**What you need to know**

about CRIS and the Business Entities, visit our websites below: