Assistant / Clinical Trial Manager

**Job Title**: Assistant/Clinical Trial 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 Clinical Trial Manager / Clinical Trial Manager will be responsible for the duties and
responsibilities listed below:
**Primary Responsibilities and Duties**

Oversee the operational readiness of assigned clinical trials within STCC.
Create and execute study specific tools and documentation.
Provide oversight, coordination and implementation of the activities, deliverables and study

conduct of assigned projects within STCC.
Manage and liaise with data management on the creation, set up, testing, maintenance of

database and database lock for clinical trials.
Oversee the data entry and cleaning process for data analysis by data monitoring committee.

Manage and liaise with biostatistician on the set up of the database, datasets transfer and
data analysis for assigned clinical trials.

Manage and liaise with drug safety/pharmacovigilance team on the set up of safety reporting
processes and templates and coordinate with the sites on the safety reporting process for
regulatory/ethics submission.

Manage and liaise with external vendors on the study drug receipt, distribution, storage,
inventories, return and destruction of study drugs according to trial SOPs at the site
pharmacy.

Manage and liaise with pharmaceutical companies/biotech companies and site pharmacists
on study drug estimation and shipment for assigned clinical trials.

Manage site monitoring and site close-out activities as per trial monitoring plan till trial
completion.

Evaluate monitoring reports to confirm appropriate conclusions and actions taken.
Perform oversight on the Clinical Research Associates (CRA) to ensure site level issues are

addressed.
Oversee clinical research study conduct and provide advice to sites to ensure smooth site

preparation and running of study within timelines.
Preparation of training materials for site selection visits, start-up meetings, study

audits/inspections etc
Conduct site initiation trainings and ad-hoc trainings to sites.
Set up, maintain, supervise and routinely review the electronic trial master file for accuracy,

timeliness and completeness.
Manage external/central laboratory activities according to trial SOPs and laboratory manual.
Manage the procurement, purchase and delivery of vendor services, liaise between the sites

and central laboratory to address any lab/sample issues.
Discuss and execute study timelines, resource allocation, trial logistics and clinical trial

processes with investigator and/or pharmaceutical companies.
Ensure all trial deliverables are met according to timelines, budget, quality and SOPs, with

compliance with GCP and set guidelines
Assist in the development and review of the clinical trial protocol and study-related

documents
Manage and train the assigned support staff on audit, monitoring, project management and

reporting activities.
Manage STCC tumour groups related activities which include development of documents

and facilitation of meetings.

**What we are looking for**

**Qualification**

Minimum Bachelor’s degree in life sciences, nursing, pharmacy, medical science or equivalent
preferred.

**Exper