Clinical Study Manager

Clinical Study Manager based in Malaysia

Your new company
Our client is a Beijing based company, national high-tech enterprise with more than 10 years of experience in the molecular diagnosis industry. It focuses on the field of point-of-care testing (POCT), and is especially good at nucleic acid detection technology for pathogenic microorganisms. It is an academician expert workstation, a national infectious disease It is the undertaking unit of major special projects, the undertaking unit of the "Torch Plan" industrialization demonstration project of the Ministry of Science and Technology, and the undertaking unit of the training project of the National Health Commission. The company has always practiced the vision of "allowing everyone to benefit from molecular diagnostics", allowing molecular diagnostics to truly come to the scene and opening the road to molecular testing that is fast, accurate, simple, portable and beneficial to the people.

Your new role
· Responsible for study design, strategy, planning (timeline, required resources and budget) for clinical studies, coordinating activities with stakeholders internally and externally and providing regular status reports.
· Responsible for the development and authoring of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regional regulations, guidelines.
· Accountable for study submission to IRB/IECs and for authoring Competent Authority submissions and may also submit to other Regulatory authorities.
· Responsible for managing and tracking of clinical studies and budget, ensuring study completion in a timely manner within budget, escalating potential issues, setting up internal and external communications for correction, trouble shooting, and prevention planning.
· Coordinate meetings and communications between investigators and within organization/teams.
· Responsible for ensuring that relevant systems e.g. EDC, are built and validated as required in order to meet study data management requirements. Accountable for data integrity, including review of data reports / files for accuracy and traceability, ensuring the timely archive and submit documentation.
· Responsible for clinical study data entry and audit; adherence to all regulations including patient privacy per organizational policies
· Identify, enlist and choose sites, and coordinating site management activities.
· Accountable for ensuring study site preparation, equipment, and training are compliant to the clinical protocols..
· Create and implement study-specific clinical monitoring tools and documents. Coordinate and supervise clinical monitoring team.
· Provide CRA with project-specific training and having regular meetings with them.
· Arrange and oversee site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality.
· Accountable for study close out procedures and reviews on study binders, datasets and study supplies.
· Accountable for supplementing data or clinical documents for any queries from authorities during submission procedures.
· Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Coyote’s high quality and ethical image.

What you'll need to succeed

· Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Coyote’s high quality and ethical image.
· Master’s degree or above, in life sciences, biomedical or clinical related areas.
· Minimum 5 years working experience of clinical study. Independent on IVD study plan / protocol design and study reports. Minimal 2 years project management experience.
· Resource for investigational sites and CROs.
· Working knowledge of Regulatory requirements e.g. FDA CFR, ICH GCP, ISO etc.
· Understanding of Electronic Data Capture (EDC), eTMF and CTMS or so clinical operation systems.
· Advanced Degree, or senior scientific research background · Working experience for multi-national IVD company · Knowledge or experience working with R&D or Regulatory
· Understand essential statistics used in study design and reports.
· Proficient with Microsoft Project or other project management tools · Working knowledge ISO20916, ISO13485, CLSI etc

· High proficiency in Mandarin, speak, write and read
· As Coyote Bioscience does not have a legal entity in Malaysia, hence the company will provide 12% extra payroll based on the basic salary for employer contribution on local retirement fund. In addition, Employee’s health benefit and insurance will also be compensated in cash for candidate to purchase the medical insurance by themselves
· Candidate requires to travel to Beijing and San Francisco once a year to work closely with their R&D team

What you'll get in return

In return, you'll be part of an organisation who values their employees. You will have a structured career growth and plenty of developmental opportunities. You will also be compensated with attractive remuneration package

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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Job Type
Working Pattern
Clinical Research

Talk to a consultant

Talk to Sudan Peng, the specialist consultant managing this position, located in London-City
4th Floor, 107 Cheapside

Telephone: 02034650158